FibromyalgiaPhase 3RE-AFFIRMNCT02829814
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
A Phase 3 study testing TNX-102 SL Tablet, 2.8 mg in people with Fibromyalgia and Myofascial Pain Syndromes, run by Tonix Pharmaceuticals, Inc. at 32 sites in United States.
Trial summary
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases
- What is being tested?
- TNX-102 SL Tablet, 2.8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 32 sitesUnited States
- Study dates
- 22 Jul 2016to 13 Sep 2016
- Phase
- Phase 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
- Male or female 18-75 years old
- Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
- Willing and able to withdraw specific therapies (ask PI)
- If female, medically acceptable form of contraception or not of child bearing potential.
- Provide written informed consent to participate.
- Willing and able to comply with all protocol specified requirement.
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-out specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, severe/untreated sleep apnea, BMI>45
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Study site
Allentown, Pennsylvania, 18104
Study site
Birmingham, Alabama, 35216
Study site
Brandon, Florida, 33511
Study site
Canton, Ohio, 44718
Study site
Cedarhurst, New York, 11516
Study site
Chattanooga, Tennessee, 37421
Study site
Cincinnati, Ohio, 45219
Study site
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
Study site
Evansville, Indiana, 47714
Study site
Fargo, North Dakota, 58103
Study site
Indianapolis, Indiana, 46260
Study site
Jackson, Mississippi, 39202
Study site
Kenosha, Wisconsin, 53142
Study site
Las Vegas, Nevada, 89102
Study site
Medford, Oregon, 97504
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Ocala, Florida, 34471
Study site
Oceanside, California, 92056
Study site
Orlando, Florida, 32801
Study site
Phoenix, Arizona, 85032
Study site
Portland, Oregon, 97210
Study site
Raleigh, North Carolina, 27612
Study site
Salem, Oregon, 97301
Study site
Salt Lake City, Utah, 84102
Study site
San Diego, California, 92103
Study site
Seattle, Washington, 98104
Study site
Tampa, Florida, 33613
Study site
Tampa, Florida, 33614
Study site
Warwick, Rhode Island, 02888
Study site
West Palm Beach, Florida, 33409
Study site
Williamsville, New York, 14221
About this study
Official title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.
The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
- Being tested
- TNX-102 SL Tablet, 2.8 mg, Placebo SL Tablet
- Keywords
- Pain, Sleep, Fibromyalgia, FM
- Medical subject headings
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases, Musculoskeletal Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNX-102 SL Tablet, 2.8 mgDrug
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.
Placebo SL TabletDrug
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 Tablet, 2.8 mg | Experimental | 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks Receives: Drug: TNX-102 SL Tablet, 2.8 mg |
| Placebo SL Tablet | Placebo comparator | 1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks Receives: Drug: Placebo SL Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Mean Pain Score
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
Measured: Day 1, Week 12
Secondary outcomes (7)
Patient's Global Impression of Change (PGIC)
Proportion of patients with a PGIC rating of "very much improved" or "much improved" 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.
Measured: Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain
Change from Baseline in the FIQR symptoms domain score at Week 12. The FIQ-R symptom domain is composed of 10 questions. All questions are based on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." Symptom domain scores range from 0-100, with higher scores reflecting worse status.
Measured: Day 1, Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score
Change from Baseline in the FIQR function domain score at Week 12. The FIQ-R functional domain score is composed of 9 questions which are rated on an 11-point numerical rating scale (NRS) of 0-10, with 10 being "worst." FIQ-R functional domain scores can range from 0-90, with higher scores reflecting worsening status.
Measured: Day 1, Week 12
Daily Diary Sleep
Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Daily sleep quality was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse sleep.
Measured: Week 12
Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance
Change from Baseline in the PROMIS score for sleep disturbance at Week 12. 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. 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: Day 1, Week 12
Patient Reported Outcomes Measurement System (PROMIS), Fatigue
Change from Baseline in the PROMIS score for fatigue at Week 12. The Patient-Reported Outcome Measurement Information System (PROMIS) fatigue 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: Week 12
Daily Diary Pain
Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score. Average daily pain was measured using an 11-point (0-10) numerical rating scale (NRS), with higher scores representing worse pain. Weekly averages were calculated based on the reported daily scores.
Measured: Week -1 (Day -7 to Day -1), Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start22 Jul 2016
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
Why it stopped: For business reason unrelated to safety or tolerability,Tonix discontinued this study.
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tonix Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829814
- Sponsor's protocol ID
- TNX-CY-F302
- Acronym
- RE-AFFIRM
- Status last verified
- Feb 2025
- First submitted
- 8 Jul 2016
- Last updated
- 25 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia
- ClinicalTrials.gov ID
- NCT02829814
- Acronym / sponsor ID
- RE-AFFIRM / TNX-CY-F302
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases
- Keywords
- Pain, Sleep, Fibromyalgia, FM
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For business reason unrelated to safety or tolerability,Tonix discontinued this study.
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2016 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 25 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.
The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.
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 Tablet, 2.8 mg | Experimental | Drug: TNX-102 SL Tablet, 2.8 mg1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks |
| Placebo SL Tablet | Placebo comparator | Drug: Placebo SL Tablet1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
- Male or female 18-75 years old
- Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
- Willing and able to withdraw specific therapies (ask PI)
- If female, medically acceptable form of contraception or not of child bearing potential.
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 Tablet, 2.8 mgAlso: 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 Tablet, 2.8 mg |
| Placebo SL TabletAlso: 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 SL Tablet |
Primary outcome
Weekly Mean Pain Score
Time frame: Day 1, Week 12
The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS). A score of 0 indicates "no pain at all", and a score of 10 indicates "worst possible pain".
7 secondary outcomes
Patient's Global Impression of Change (PGIC)
Time frame: Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Symptoms Domain
Time frame: Day 1, Week 12
Fibromyalgia Impact Questionnaire (FIQR) Revised, Functional Domain Score
Time frame: Day 1, Week 12
Daily Diary Sleep
Time frame: Week 12
Patient Reported Outcomes Measurement System (PROMIS), Sleep Disturbance
Time frame: Day 1, Week 12
Patient Reported Outcomes Measurement System (PROMIS), Fatigue
Time frame: Week 12
Daily Diary Pain
Time frame: Week -1 (Day -7 to Day -1), Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TNX-102 SL Tablet, 2.8 mg in people with Fibromyalgia and Myofascial Pain Syndromes, run by Tonix Pharmaceuticals, Inc. at 32 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 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: stopped early, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 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 25 Feb 2025). 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?
Weekly Mean Pain Score (time frame: Day 1, 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 25 Feb 2025.