Primary FibromyalgiaPhase 2/3BESTFITNCT01903265
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
A Phase 2/3 study testing TNX-102 SL 2.8mg in people with Primary Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Primary Fibromyalgia
- What is being tested?
- TNX-102 SL 2.8mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 17 sitesUnited States
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 2/3
- 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
- Diagnosis of primary Fibromyalgia (ACR criteria)
- Male or female 18-65 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
- Signed informed consent
Who cannot join
- Arthritis, lupus and other systemic auto-immune diseases
- Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- Bipolar and psychotic disorders
- Increased risk of suicide
- Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
- Inability to wash-off specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI>40
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
1951 152nd Place NE
Bellevue, Washington, 98007
16176 Cortez Boulevard
Brooksville, Florida, 34601
3401 North Central Avenue
Chicago, Illinois, 60634
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
1275 Olentangy River Road
Columbus, Ohio, 43212
Radiant Research, Inc.
Denver, Colorado, 80239
71 Thomas Johnson Drive
Frederick, Maryland, 21702
322 Memorial Drive
Greer, South Carolina, 29650
CRC of Jackson, LLC
Jackson, Mississippi, 39202
1001 South Market Street
Mechanicsburg, Pennsylvania, 17055
18660 Bagley Road
Middleburg Heights, Ohio, 44130
370 Faunce Corner Road
North Dartmouth, Massachusetts, 02747
100 West Gore Street
Orlando, Florida, 32806
107 Scripps Drive
Sacramento, California, 95825
1002 E. South Temple
Salt Lake City, Utah, 84102
601 Broadway
Seattle, Washington, 98122
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
About this study
Official title: A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
- Conditions
- Primary Fibromyalgia
- Being tested
- TNX-102 SL 2.8mg, Placebo
- Keywords
- pain, sleep
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-102 SL 2.8mgDrug
Also called Low dose cyclobenzaprine sublingual tablets
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
PlaceboDrug
Also called Placebo sublingual tablets
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL 2.8 mg | Experimental | Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. Receives: Drug: TNX-102 SL 2.8mg |
| Placebo | Placebo comparator | Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
Measured: Baseline, Week 12
Secondary outcomes (4)
30% Responder Analysis of IVRS NRS Pain Assessments at Week 12
The weekly averages of daily pain scores were calculated using the daily, 24-hour-recall, IVRS NRS pain assessments.
Patients who had at least a 30% improvement from baseline to week 12 in weekly average of daily pain scores were considered responders.
Measured: Baseline, Week 12
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
The Patient-Reported Outcome Measurement Information System (PROMIS) sleep disturbance instrument consists of 8 items in which responses are scored 1 to 5 for each item. A higher score on 5 of the 8 items reflects a worse outcome, whereas a higher score on 3 items reflects an improved outcome; therefore, the directionality of the 8 item scores are first synchronized prior to calculation of the total raw score. PROMIS scores are presented as T-scores in which the raw score has been rescaled into a standardized score with a mean of 50 and a standard deviation of 10. Higher T-scores represent more of the concept being measured (in this case, sleep disturbance).
Measured: Baseline, Week 12
Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12
The PGIC is a 7-point scale (1=very much improved; 7=very much worse) that assesses the patient's perception of the overall change in his/her fibromyalgia symptoms since entering the study. Scores of 1 and 2 were considered responders.
Measured: Week 12
Change From Baseline to Week 12 in FIQ-R Total Score
The Fibromyalgia Impact Questionnaire (revised) FIQ-R is made up of 3 domains: functional (9 questions), overall (2 questions) and symptoms (10 questions). All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Total FIQ-R scores can range from 0-100, with higher scores reflecting worsening status. The patient's total score on the FIQ-R was assessed at Visits 2, 3, 4, 5, and 6 (Week 12). Jump to control was used to replace missing data in each treatment arm.
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionSep 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.
- Other trials for Primary 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark R. Schmal, Study director, Premier ResearchDaniel J. Clauw, MD, Study chair, Ann Arbor, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903265
- Sponsor's protocol ID
- TNX-CY-F202
- Acronym
- BESTFIT
- Status last verified
- Oct 2016
- First submitted
- 12 Jul 2013
- Last updated
- 23 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Tablets Taken at Bedtime in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01903265
- Acronym / sponsor ID
- BESTFIT / TNX-CY-F202
- Conditions
- Primary Fibromyalgia
- Keywords
- pain, sleep
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jul 2013 (estimated)
- Results
- Posted 23 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TNX-102 capsules [formerly known as very low dose (VLD) cyclobenzaprine] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL 2.8 mg | Experimental | Drug: TNX-102 SL 2.8mgPatients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of primary Fibromyalgia (ACR criteria)
- Male or female 18-65 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
Key exclusion criteria (8 listed)
- Arthritis, lupus and other systemic auto-immune diseases
- Regional or persistent pain that could interfere with assessment of fibromyalgia pain
- Bipolar and psychotic disorders
- Increased risk of suicide
- Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
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 |
|---|---|---|
| TNX-102 SL 2.8mgAlso: Low dose cyclobenzaprine sublingual tabletsPatients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. | Drug | TNX-102 SL 2.8 mg |
| PlaceboAlso: Placebo sublingual tabletsPatients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. | Drug | Placebo |
Primary outcome
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12
Time frame: Baseline, Week 12
Daily pain scores were assessed using a 24-hour recall response provided by each patient via an interactive voice response system (IVRS) daily telephone diary. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Jump to control was used to replace missing data in each treatment arm.
4 secondary outcomes
30% Responder Analysis of IVRS NRS Pain Assessments at Week 12
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in PROMIS T-score for Sleep Disturbance
Time frame: Baseline, Week 12
Patient Global Impression of Change (PGIC) Responder Status ("Very Much Improved" or "Much Improved" vs All Other Categories) at Week 12
Time frame: Week 12
Change From Baseline to Week 12 in FIQ-R Total Score
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Mark R. Schmal study director
Premier Research
Daniel J. Clauw, MD study chair
Ann Arbor, MI
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TNX-102 SL 2.8mg in people with Primary Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 17 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 6 inclusion and 8 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 23 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Dec 2016). 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?
Mean Change From Baseline in Weekly Average of Daily Pain Scores at Week 12 (time frame: Baseline, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2016.