FibromyalgiaPhase 2NCT01693692

Phase 2 Study of TD-9855 to Treat Fibromyalgia

A Phase 2 study testing TD-9855 Group 1 and TD-9855 Group 2 in people with Fibromyalgia, run by Theravance Biopharma at 34 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Fibromyalgia
What is being tested?: TD-9855 Group 1 and TD-9855 Group 2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 392 participants
Where: 34 sitesUnited States
Study dates: Nov 2012to Apr 2014
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

• American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)
Informed consent
18 to 65 years of age
Discontinue therapy with adrenergic-acting drugs, and certain other medications
Only acetaminophen or NSAID as rescue pain medication
No narcotic pain meds or benzodiazepines
Only non-benzodiazepines as rescue hypnotics

Who cannot join

Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
Risk of suicide (investigator opinion and/or C-SSRS)
Recent history of substance or alcohol abuse
BMI <18 or ≥45
Concurrent disease; pain for diagnosed illness other than FM; non-compliance; history of seizures; pheochromocytoma; glaucoma; CV disease; orthostatic hypotension or orthostatic tachycardia; untreated sleep apnea
Abnormal lab values (liver, kidney, thyroid, and others)

Trial locations and contacts

34 sites in 1 country.

City, postcode or hospital

34 sites in 1 country

United States34 sites

Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
PAB Clinical Research
Brandon, Florida, 33511
Beacon Clinical Research
Brockton, Massachusetts, 02301
ClinSearch, LLC
Chattanooga, Tennessee, 37421
University of Cincinnati
Cincinnati, Ohio, 45219
Meridian Clinical Research
Dakota Dunes, South Dakota, 57049
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates, LLC
El Cajon, California, 92020
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Lillestol Research, LLC
Fargo, North Dakota, 58103
Dedicated Clinical Research
Goodyear, Arizona, 85395
Clinical Investigation Specialists, Inc.
Gurnee, Illinois, 60031
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
Meridien Research
Lakeland, Florida, 33805
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Beacon Clinical Research
New Bedford, Massachusetts, 02740
Coastal Connecticut Research, LLC
New London, Connecticut, 06320
Renstar Medical Research
Ocala, Florida, 34471
Meridian Clinical Research
Omaha, Nebraska, 68134
Compass Research, LLC
Orlando, Florida, 32806
Clinical Research Source, Inc.
Perrysburg, Ohio, 43551
Arroyo Medical Group, Inc.
Pismo Beach, California, 93449
Wake Research Associates
Raleigh, North Carolina, 27612
Carolina Center for Rheumatology & Arthritis Care
Rock Hill, South Carolina, 29732
Swedish Rheumatology Research
Seattle, Washington, 98104
GTC Research
Shawnee Mission, Kansas, 66218
Tulsa Clinical Research, LLC
Tulsa, Oklahoma, 74104
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Omega Medical Research
Warwick, Rhode Island, 02886
Upstate Clinical Research Associates, LLC
Williamsville, New York, 14221
The Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)

The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.

Conditions: Fibromyalgia
Being tested: TD-9855 Group 1, TD-9855 Group 2, Placebo
Keywords: Fibromyalgia
Medical subject headings: Fibromyalgia

What participants receive

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

TD-9855 Group 1Drug
TD-9855 Group 2Drug
PlaceboDrug

Study groups in NCT01693692
Study group	Role	What they receive
TD-9855 Group 1	Experimental	Group 1 to be dosed with TD-9855 Receives: Drug: TD-9855 Group 1
TD-9855 Group 2	Experimental	Group 2 to be dosed with TD-9855 Receives: Drug: TD-9855 Group 2
Placebo	Placebo comparator	Group to be dosed with Placebo Receives: Drug: Placebo

What is being measured

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

Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.
Measured: Baseline and Week 6

Secondary outcomes (2)

Fibromyalgia Impact Questionnaire (FIQ)
FIQ score is based on the total score from 0 to 100 gained from 10 questions, where a lower total score represents less impact from fibromyalgia.
Measured: Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)
PGIC score is based on a 7-category scale where a score of 1 indicates the participant's condition is very much improved, and a score of 7 indicates the participant's condition is very much worse.
Measured: Day 43 (End of study treatment)

Timeline

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

Nov 2012Apr 2014

First posted26 Sep 2012 (estimated)
Study startNov 2012
Primary completionJan 2014
Study completionApr 2014

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 392 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01693692
Sponsor's protocol ID: 0092
Status last verified: Feb 2022
First submitted: 20 Sep 2012
Last updated: 4 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Publications

Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.
PubMed 32856281

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

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
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
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 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of TD-9855 in Patients With Fibromyalgia (FM)
ClinicalTrials.gov ID: NCT01693692
Acronym / sponsor ID: 0092
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 392 participants (actual)
Lead sponsor: Theravance BiopharmaIndustry (pharma, biotech, devices)
Study start: Nov 2012 (actual)
Primary completion: Jan 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 26 Sep 2012 (estimated)
Results: Posted 4 Mar 2022

Clinical summary

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

The purpose of this study study is to determine whether TD-9855 is effective in treating patients with fibromyalgia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TD-9855 Group 1	Experimental	Drug: TD-9855 Group 1Group 1 to be dosed with TD-9855
TD-9855 Group 2	Experimental	Drug: TD-9855 Group 2Group 2 to be dosed with TD-9855
Placebo	Placebo comparator	Drug: PlaceboGroup to be dosed with Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

• American College of Rheumatology (ACR) Diagnostic Criteria for Fibromyalgia (FM)

Key exclusion criteria (7 listed)

Any current psychiatric disorder, lifetime bipolar disorder, severe comorbid Axis II disorder, mental retardation, etc, as assessed by Mini International Neuropsychiatric Interview (MINI)
Major depression at screening by MINI when unable to be washed out of MDD meds (investigator or provider's judgment)
Risk of suicide (investigator opinion and/or C-SSRS)
Recent history of substance or alcohol abuse
BMI <18 or ≥45

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
TD-9855 Group 1	Drug	TD-9855 Group 1
TD-9855 Group 2	Drug	TD-9855 Group 2
Placebo	Drug	Placebo

Primary outcome

Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries
Time frame: Baseline and Week 6
Pain NRS score is based on an 11-point scale where 0 represents no pain and 10 represents the worst possible pain.

2 secondary outcomes

Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Day 43 (End of study treatment)
Patient Global Impression of Change (PGIC)
Time frame: Day 43 (End of study treatment)

Results and safety

Results posted to the registry on 4 Mar 2022, 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	130	100
TD-9855 Group 1	131	97
TD-9855 Group 2	131	95

Primary outcome: Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries

Time frame: Baseline and Week 6. Least squares mean (Standard Error). Unit: percentage change

Measure	Placebo n = 126	TD-9855 Group 1 n = 122	TD-9855 Group 2 n = 125
Value	-0.9 (0.17)	-1.2 (0.18)	-1.4 (0.17)

Placebo vs TD-9855 Group 1: Mean Difference (Final Values): -0.24, p = 0.1683, ANCOVA
Placebo vs TD-9855 Group 2: Mean Difference (Final Values): -0.47, p = 0.0277, ANCOVA

Population analysed: Only participants with available data were used for this analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 63. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 128 (0%)	71 of 128 (55.5%)	0 of 128
TD-9855 Group 1	1 of 127 (0.8%)	78 of 127 (61.4%)	0 of 127
TD-9855 Group 2	1 of 128 (0.8%)	90 of 128 (70.3%)	0 of 128

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32856281Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.
Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Related trials for Fibromyalgia

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
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
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

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.

Medical Monitor study director

Theravance Biopharma

34 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 TD-9855 Group 1 and TD-9855 Group 2 in people with Fibromyalgia, run by Theravance Biopharma at 34 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 7 inclusion and 7 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 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 4 Mar 2022). 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?

Percentage Change in Pain Score Based on the Mean of the Last 7 Daily Pain Numeric Rating Scale (NRS) Scores From the Daily Pain Diaries (time frame: Baseline and Week 6). 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 NCT01693692, which also lists 1 linked publication.

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 4 Mar 2022.