Primary FibromyalgiaPhase 3NCT02589275
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
A Phase 3 study testing TNX-102 SL Tablet 2.8 mg in people with Primary Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 33 sites in United States.
Trial summary
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Fibromyalgia
- What is being tested?
- TNX-102 SL Tablet 2.8 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 33 sitesUnited States
- Study dates
- 4 Aug 2015to 28 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
- The patient met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
- The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
- The patient has provided written informed consent to participate in this extension protocol.
Who cannot join
- None
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Study site
Allentown, Pennsylvania, 18104
Study site
Ann Arbor, Michigan, 48104
Study site
Bellevue, Washington, 98007
Study site
Birmingham, Alabama, 35216
Study site
Brandon, Florida, 33511
Study site
Charlottesville, Virginia, 22911
Study site
Cincinnati, Ohio, 45206
Study site
Columbus, Georgia, 31904
Study site
Dallas, Texas, 75231
Study site
DeLand, Florida, 32720
Study site
Evansville, Indiana, 47714
Study site
Greer, South Carolina, 29650
Study site
Jackson, Mississippi, 39202
Study site
Kenosha, Wisconsin, 53142
Study site
Lakeland, Florida, 33805
Study site
Medford, Oregon, 97504
Study site
Middleburg Heights, Ohio, 44130
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Norfolk, Virginia, 23507
Study site
North Dartmouth, Massachusetts, 02747
Study site
Ocala, Florida, 34471
Study site
Orlando, Florida, 32806
Study site
Phoenix, Arizona, 85032
Study site
Portland, Oregon, 97210
Study site
Sacramento, California, 95825
Study site
Salt Lake City, Utah, 84102
Study site
San Diego, California, 92103
Study site
Seattle, Washington, 98104
Study site
Smyrna, Georgia, 30080
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 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.
Patients will not be made aware of the therapy they received during the double-blind study.
Read the detailed description
The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).
Primary:
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study
Secondary:
The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM
- Conditions
- Primary Fibromyalgia
- Being tested
- TNX-102 SL Tablet 2.8 mg
- Keywords
- TNX-102 SL, bedtime, sublingual, 3-month, long term safety, long term efficacy, Fibromyalgia
- Medical subject headings
- Fibromyalgia
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 cyclobenzaprine
TNX-102 SL 2.8 mg tablet taken daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| TNX-102 SL Tablet 2.8 mg | Experimental | 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months Receives: Drug: TNX-102 SL Tablet 2.8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newly Emergent Adverse Events
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
Measured: Up to 3 months from first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study start4 Aug 2015
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 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
- NCT02589275
- Sponsor's protocol ID
- TNX-CY-F303
- Status last verified
- Feb 2025
- First submitted
- 19 Oct 2015
- Last updated
- 20 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02589275
- Acronym / sponsor ID
- TNX-CY-F303
- Conditions
- Primary Fibromyalgia
- Keywords
- TNX-102 SL, bedtime, sublingual, 3-month, long term safety, long term efficacy, Fibromyalgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Tonix Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2015 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 11 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.
Patients will not be made aware of the therapy they received during the double-blind study.
Detailed description
The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).
Primary:
The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study
Secondary:
The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNX-102 SL Tablet 2.8 mg | Experimental | Drug: TNX-102 SL Tablet 2.8 mg1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient met all prior inclusion and exclusion requirements for study F301 or F302 originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
- The patient completed expected dosing in F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
- The patient has provided written informed consent to participate in this extension protocol.
Key exclusion criteria (1 listed)
- None
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: cyclobenzaprineTNX-102 SL 2.8 mg tablet taken daily at bedtime | Drug | TNX-102 SL Tablet 2.8 mg |
Primary outcome
Newly Emergent Adverse Events
Time frame: Up to 3 months from first dose
The number of patients with at least one adverse event which began after the first dose of TNX-102 SL in this open-label extension study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
33 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 Primary Fibromyalgia, run by Tonix Pharmaceuticals, Inc. at 33 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 3 inclusion and 1 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 20 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 33 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. 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 11 Dec 2024). 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?
Newly Emergent Adverse Events (time frame: Up to 3 months from first dose). 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 20 Feb 2025.