FibromyalgiaPhase 2NCT03092726

A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

A Phase 2 study testing ASP8062 in people with Fibromyalgia, run by Astellas Pharma Global Development, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as well as the safety and tolerability. This study also assessed the treatment differences in physical function as well the improvements in overall subject status (e.g., fibromyalgia symptoms, global functioning) of ASP8062… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Fibromyalgia
What is being tested?: ASP8062
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 183 participants
Where: 24 sitesUnited States
Study dates: 8 May 2017to 6 Mar 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has a body mass index (BMI) ≤ 45 kg/m^2.
Female subject must either:
Be of nonchildbearing potential:
Postmenopausal (defined as at least 1 year without any menses) prior to Screening, or,
Documented surgically sterile (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
Or, if of childbearing potential, agree not to try to become pregnant during the study and for 28 days after the final study drug administration, have a negative blood pregnancy test at Screening and negative urine test on Day 1, and if heterosexually active, agree to consistently use 1 form of highly effective birth control starting at Screening and throughout the study period and for 28 days after the final study drug administration.

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Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration.
A sexually active male subject with female partner(s) who are of childbearing potential is eligible if:
Agree to use a male condom starting at screening and continue throughout study treatment and for 90 days after the final study drug administration. If the male subject has not had a vasectomy or is not sterile the male subjects female partner(s) is utilizing 1 form of highly effective birth control starting at screening and continue throughout study treatment, and for 90 days after the male subject receives final study drug administration.
Male subject with a partner of child-bearing potential, or a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom throughout the study period and for 90 days after the final study drug administration.
Subject meets the American College of Rheumatology (ACR) 1990 fibromyalgia diagnostic criteria at Screening:
Widespread pain for at least 3 months, defined as the presence of all of the following: Pain above and below the waist and pain in the axial skeleton (cervical spine or anterior chest or thoracic spine or low back) must be present.
Pain in at least 11 of 18 tender point sites on digital palpation. Digital palpation should be performed with an approximate force of 4 kg.
Subject meets the ACR 2010 fibromyalgia diagnostic criteria at Screening:
Widespread pain index (WPI) ≥ 7 and symptom severity (SS) scale score ≥ 5 or WPI 3-6 and SS scale score ≥ 9.
Symptoms have been present at a similar level for at least 3 months.
The subject does not have a disorder that would otherwise explain the pain.
Subject has a pain score ≥ 4 on the revised fibromyalgia impact questionnaire (FIQR) pain item at Screening.
Subject is compliant with daily pain recordings during the Baseline Diary Run-In period, as defined by the completion of a minimum of 5 of 7 daily average pain ratings and agrees to complete daily diaries throughout the duration of the study.
Subject has a mean daily average pain score ≥ 4 and ≤ 9 on an 11-point 0 to 10 NRS as recorded in the subject e-diary during the Baseline Diary Run-In period, and meeting pre-specified criteria for daily average pain scores.
Subject agrees to use only acetaminophen as rescue medication for fibromyalgia pain throughout the course of the trial (up to 1000 mg per dose and not to exceed 3000 mg/day).
Subject agrees not to initiate or change any non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) during the course of the study. Non-pharmacologic interventions must be stable for a minimum of 30 days prior to Screening. And subject agrees to maintain usual level of activity for the duration of the study.
Subject is capable of completing study assessments and procedures.
Subject agrees not to participate in another interventional study from Screening through the End of Study (EOS) visit.

Who cannot join

Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
Subject has had no meaningful improvement from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes).
Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP8062.
Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation.
Subject has infectious or inflammatory arthritis (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia.
Subject has a current, untreated moderate or severe major depressive disorder as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.). Subject with current, treated major depressive disorder can be included provided that it is without clinically significant changes in symptoms while on the same dose of a protocol allowed antidepressant for greater than 60 days prior to Screening.

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Subject has initiated any non-pharmacologic interventions for the treatment of fibromyalgia or depression within 30 days prior to Screening or during the Screening period.
Subject has a history of any psychotic and/or bipolar disorder as assessed by the M.I.N.I.
Subject has a Hospital Anxiety and Depression Scale (HADS) score > 14 on the Depression subscale at Screening or at the time of Visit 3 (Randomization).
Subject has a history of suicide attempt or suicidal behavior within the last 12 months, or has suicidal ideation within the last 12 months (a response of "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale C-SSRS]), or who is at significant risk to commit suicide at Screening and at the time of Visit 3 (Randomization).
Subject has clinically significant abnormalities in clinical chemistry, hematology, or urinalysis, or a serum creatinine > 1.5 x the ULN at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
Subject has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of the reference range at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
Subject has a positive test for hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (immunoglobulin M) (anti-HAV [IgM]) or hepatitis C virus antibodies (anti-HCV) at Screening or has history of a positive test for human immunodeficiency virus type 1(HIV-1) and/or type 2 (HIV-2).
Subject has a resting systolic blood pressure > 180 mmHg or < 90 mmHg, and/or a sitting diastolic blood pressure > 100 mmHg at Screening. These assessments may be repeated once, after a reasonable time period (but within the Screening period).
Subject has a clinically significant abnormality on 12-lead electrocardiogram (ECG) at Screening or Visit 3 (Randomization). If the ECG is abnormal an additional ECG can be carried out. If this also gives an abnormal result, the subject must be excluded.
Subject has a history of myocardial infarction (within 6 months of Screening), unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsade de pointes, structural heart disease or a family history of Long QT Syndrome.
Subject has evidence of any clinically significant, uncontrolled cardiovascular, gastrointestinal, endocrinologic (low thyroid stimulating hormone [TSH], but euthyroid is allowed), hematologic, hepatic, immunologic, infectious, metabolic, urologic, pulmonary (including obstructive sleep apnea not controlled by a continuous positive airway pressure device) neurologic, dermatologic, psychiatric, renal and/or other major disease (exclusive of fibromyalgia).
Subject has planned surgery during the study participation.
Subject has an active malignancy or a history of malignancy (except for treated nonmelanoma skin cancer) within 5 years of Screening.
Subject has a positive drug or alcohol test at Screening, Baseline Diary Run-In or prior to Randomization. However, a positive test for tetrahydrocannabinol (THC) and/or opioids is allowed at the Screening visit, but must be confirmed negative prior to Baseline Diary Run-In and Randomization.
Subject has a current or recent (within 12 months of Screening) history of a substance use disorder including cannabinoid and/or alcohol abuse disorder. Subject has used opioids for pain for more than 4 days during the week preceding the Screening visit.
Subject is currently using protocol specified prohibited medications and is unable to wash-out including over-the-counter (OTC) products and grapefruit and/or grapefruit juice.
Subject has filed or is awaiting judgment on a disability claim or has any pending worker's compensation litigation or related monetary settlements.
Subject has any condition which makes the subject unsuitable for study participation.
Subject is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site personnel directly affiliated with this study and/or immediate families (spouse, parent, child, or sibling, whether biological or legally adopted).

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
PAB Clinical Research
Brandon, Florida, 33511
NY Scientific
Brooklyn, New York, 11235
Neuro-Behavioral Clinical Research, Inc
Canton, Ohio, 44718
Neurobehavioral Research, Inc
Cedarhurst, New York, 11516
ClinSearch, LLC
Chattanooga, Tennessee, 37421
Chicago Research Center, Inc
Chicago, Illinois, 60634
University of Cincinnati
Cincinnati, Ohio, 45219
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049
Avail Clinical Research, LLC
DeLand, Florida, 32720
Medisphere Medical Research Center, LLC
Evansville, Indiana, 47714
Elite Clinical Research, LLC
Jackson, Mississippi, 39202
The Center For Pharmaceutical Research
Kansas City, Missouri, 64114
Clinical Investigation Specialists, Inc
Kenosha, Wisconsin, 53142
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Infinity Medical Research, Inc
North Dartmouth, Massachusetts, 02747
Excell Research, Inc
Oceanside, California, 92056
Clinical Neuroscience Solutions, Inc
Orlando, Florida, 32801
Noesis Pharma, LLC
Phoenix, Arizona, 85032
Summit Research Network
Portland, Oregon, 97210
Private Practice
Raleigh, North Carolina, 27609
Collaborative Neuroscience Network, LLC.
Torrance, California, 90502
Omega Medical Research
Warwick, Rhode Island, 02886
PMG of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia

Conditions: Fibromyalgia
Being tested: ASP8062, Placebo
Keywords: ASP8062, Fibromyalgia
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ASP8062Drug
ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.
PlaceboDrug
Placebo was administered orally as a single daily dose, taken preferably in the morning with or without food.

Study groups in NCT03092726
Study group	Role	What they receive
ASP8062	Experimental	Participants received 30 mg of ASP8062 orally once daily for 8 weeks. Receives: Drug: ASP8062
Placebo	Placebo comparator	Participants received matching placebo orally once daily for 8 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)
The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors "no pain" and 10 "pain as bad as you can imagine." The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).
Measured: Baseline and week 8
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A TEAE was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs in drug abuse, dependence and withdrawal standardized MedDRA query (SMQ) are special AEs of interest grouped together using the SMQ tool (MedDRA v20.0).
Measured: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
The Columbia Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent).
Measured: Weeks 1 to 8
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide).
Measured: Weeks 1 to 8

Secondary outcomes (6)

Percentage of Participants With ≥ 30% Reduction From Baseline to Week 8 and End of Treatment (EOT) in Mean Daily Average Pain Score as Assessed by NRS
The mean daily average pain score was assessed through the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors "no pain" and 10 "pain as bad as you can imagine." The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT analysis, participants with missing baseline or EOT data were classified as nonresponders.
Measured: Baseline to week 8
Percentage of Participants With ≥ 50% Reduction From Baseline to Week 8 and EOT in Mean Daily Average Pain Score as Assessed by NRS
The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors "no pain" and 10 "pain as bad as you can imagine." The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. For the week 8 analysis, participants with missing baseline or week 8 data were classified as nonresponders. For EOT analysis, participants with missing baseline or EOT data were classified as nonresponders.
Measured: Baseline to week 8
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
The FIQR was developed to capture total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days or the last time the activity was performed if not within the 7-day recall period. The Function subscale has a range of scores of 0 to 90, with a lower score indicating better (higher) function. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).
Measured: Baseline and weeks 2, 4, 8
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Symptoms subscale range of scores is 0 to 100, with a lower score indicating a better (lower) level of symptoms. A negative change indicates a reduction/improvement from baseline (i.e., a favorable outcome).
Measured: Baseline and weeks 2, 4, 8
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
The FIQR was developed to capture the total spectrum of problems related to fibromyalgia and the responses to therapy. The 21-item FIQR contains 3 subscales: function (9 questions), overall impact (2 questions), and symptoms (10 questions). Participants answer each question on an 11-point NRS, with anchors appropriate to each question on a tablet device during a visit. The recall period was the last 7 days. The Overall Impact subscale has a range of scores from 0 to 20, with a lower score indicating better (lower) impact. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).
Measured: Baseline and weeks 2, 4, 8
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
The PGIC is a self-administered 7-point Likert scale that asks participants to evaluate their fibromyalgia relative to baseline. This is a single question and the grade ranges from 1 ("Very Much Improved") to 7 ("Very Much Worse").
Measured: Weeks 2, 4, 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 20176 Mar 2018

First posted28 Mar 2017
Study start8 May 2017
Primary completion6 Mar 2018
Study completion6 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by Astellas Pharma Global Development, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 183 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03092726
Sponsor's protocol ID: 8062-CL-0101
Status last verified: Oct 2025
First submitted: 10 Mar 2017
Last updated: 3 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2a, Randomized, Double-Blind Placebo-controlled, Parallel-group Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia
ClinicalTrials.gov ID: NCT03092726
Acronym / sponsor ID: 8062-CL-0101
Conditions: Fibromyalgia
Keywords: ASP8062, Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 183 participants (actual)
Lead sponsor: Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
Study start: 8 May 2017 (actual)
Primary completion: 6 Mar 2018 (actual)
Study completion: 6 Mar 2018 (actual)
First posted: 28 Mar 2017 (actual)
Results: Posted 28 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ASP8062	Experimental	Drug: ASP8062Participants received 30 mg of ASP8062 orally once daily for 8 weeks.
Placebo	Placebo comparator	Drug: PlaceboParticipants received matching placebo orally once daily for 8 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Subject has a body mass index (BMI) ≤ 45 kg/m^2.
Female subject must either:
Female subject must agree not to breastfeed at Screening and throughout the study period, and for 28 days after the final study drug administration.
Female subject must not donate ova starting at Screening, throughout the study period, and for 28 days after the final study drug administration.
Male subject must not donate sperm starting at Screening and throughout the study period, and for 90 days after the final study drug administration.

Key exclusion criteria (25 listed)

Subject has received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
Subject has had no meaningful improvement from 2 or more prior treatments (commercially available) for fibromyalgia (in at least 2 pharmacologic classes).
Subject has had known hypersensitivity or intolerance to the use of acetaminophen or associated formulation components; known hypersensitivity to the formulation components of ASP8062.
Subject has pain due to diabetic peripheral neuropathy, post-herpetic neuralgia, traumatic injury, prior surgery, complex regional pain syndrome, or other source of pain that would confound or interfere with the assessment of the subject's fibromyalgia pain or require excluded therapies during the subject's study participation.
Subject has infectious or inflammatory arthritis (for example, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, gout), autoimmune disease (for example, systemic lupus erythematosus), or other widespread rheumatic disease other than fibromyalgia.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ASP8062ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.	Drug	ASP8062
PlaceboPlacebo was administered orally as a single daily dose, taken preferably in the morning with or without food.	Drug	Placebo

Primary outcome

Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)
Time frame: Baseline and week 8
The mean daily average pain score was assessed thorugh the Daily Average Pain NRS, which is a generic instrument for the assessment of pain that consists of a single question that asks participants to record their daily average pain on an 11-point scale, where 0 anchors "no pain" and 10 "pain as bad as you can imagine." The mean daily average pain score was calculated from data recorded by participants daily in the electronic diary, and the recall period was the last 24 hours. A negative change indicated a reduction/improvement from baseline (i.e., a favorable outcome).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days)
Safety was assessed by adverse events (AEs), which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study drug or was clinically significant. A TEAE was defined as any AE that started or worsened after the first dose of study drug up to 30 days after the last dose of study drug. AEs were considered serious (SAEs) if the AE resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, resulted in congenital anomaly, or birth defect or required inpatient hospitalization or led to prolongation of hospitalization. TEAEs in drug abuse, dependence and withdrawal standardized MedDRA query (SMQ) are special AEs of interest grouped together using the SMQ tool (MedDRA v20.0).
Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation
Time frame: Weeks 1 to 8
The Columbia Suicide Severity Rating Scale (C-SSRS) is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods (not plan) without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent).
Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior
Time frame: Weeks 1 to 8
The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses were provided to 5 items to suicidal behavior (1. Preparatory acts or behavior, 2. Aborted attempt, 3. Interrupted attempt, 4. Actual attempt, 5. Completed suicide).

6 secondary outcomes

Percentage of Participants With ≥ 30% Reduction From Baseline to Week 8 and End of Treatment (EOT) in Mean Daily Average Pain Score as Assessed by NRS
Time frame: Baseline to week 8
Percentage of Participants With ≥ 50% Reduction From Baseline to Week 8 and EOT in Mean Daily Average Pain Score as Assessed by NRS
Time frame: Baseline to week 8
Change From Baseline to Weeks 2, 4, 8 and EOT in the Fibromyalgia Impact Questionnaire Revised (FIQR) Function Subscale Score
Time frame: Baseline and weeks 2, 4, 8
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Symptoms Subscale Score
Time frame: Baseline and weeks 2, 4, 8
Change From Baseline to Weeks 2, 4, 8, and EOT in the FIQR Overall Impact Subscale Score
Time frame: Baseline and weeks 2, 4, 8
Overall Participant Improvement as Assessed by Patient Global Impression of Change (PGIC)
Time frame: Weeks 2, 4, 8

Results and safety

Results posted to the registry on 28 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	88	79
ASP8062	95	81

Primary outcome: Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS)

Time frame: Baseline and week 8. Least squares mean (Standard Error). Unit: Units on a scale

Measure	Placebo n = 88	ASP8062 n = 95
Value	-1.42 (0.19)	-1.36 (0.19)

Placebo vs ASP8062: LS Mean (LSM) Difference: 0.06 (90% CI -0.38 to 0.50), p = 0.590, MMRM

Population analysed: The analysis population was the full analysis set (FAS), which consisted of all randomized participants who took at least 1 dose of study drug. Participants with available data at baseline were included in the analysis.

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days). Count of participants. Unit: Participants

Measure	Placebo n = 88	ASP8062 n = 95
Any TEAE	43	67
Drug-related TEAE	19	45
Serious TEAE	0	0
Drug-related serious TEAE	0	0
TEAE leading to withdrawal of treatment	3	10
Death	0	0
TEAE in drug abuse, dependence, withdrawal SMQ	0	0
TEAE in drug abuse and dependence SMQ	0	0

Population analysed: The analysis population was the SAF.

Primary outcome: Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation

Time frame: Weeks 1 to 8. Count of participants. Unit: Participants

Measure	Placebo n = 86	ASP8062 n = 90
Wish to be dead	1	1
Non-specific active suicidal thoughts	0	0
With any methods (not plan) w/o intent to act	0	0
With some intent to act, w/o specific plan	0	0
With specific plan and intent	0	0

Population analysed: The analysis population was the SAF. Participants with available data were included in the analysis.

Primary outcome: Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behavior

Time frame: Weeks 1 to 8. Count of participants. Unit: Participants

Measure	Placebo n = 86	ASP8062 n = 90
Preparatory acts or behavior	0	0
Aborted attempt	0	0
Interrupted attempt	0	0
Actual attempt	0	0
Completed suicide	0	0

Population analysed: The analysis population was the SAF. Participants with available data were included in the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of study drug up to 30 days after last dose of study drug (up to 87 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 88 (0%)	17 of 88 (19.3%)	0 of 88
ASP8062 30 mg	0 of 95 (0%)	38 of 95 (40%)	0 of 95

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Executive Director study director

Astellas Pharma Global Development, Inc.

24 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ASP8062 in people with Fibromyalgia, run by Astellas Pharma Global Development, Inc. at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 8 in Mean Daily Average Pain Score as Assessed by Numerical Rating Scale (NRS) (time frame: Baseline and week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03092726.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.