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FibromyalgiaPhase 3AFFIRMNCT02436096

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, 2.8mg in people with Fibromyalgia and Myofascial Pain Syndromes, run by Tonix Pharmaceuticals, Inc. at 35 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 use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TNX-102 SL Tablet, 2.8mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
519 participants
Where
35 sitesUnited States
Study dates
Apr 2015to 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
  • For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant 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-out specific medications (ask PI)
  • Known hypersensitivity to cyclobenzaprine
  • Others: seizure disorders, severe/untreated sleep apnea, BMI>40

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 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

    Columbus, Ohio, 43212

  • 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, 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

Other trials in United States

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 use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

The present trial is 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.

Being tested
TNX-102 SL Tablet, 2.8mg, Placebo SL Tablet
Keywords
Pain, Sleep
Medical subject headings
Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic 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, 2.8mgDrug

    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 1 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 1 for 12 weeks.

Study groups in NCT02436096
Study groupRoleWhat they receive
TNX-102 SL Tablet, 2.8 mgExperimental1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
Receives: Drug: TNX-102 SL Tablet, 2.8mg
Placebo SL TabletPlacebo comparator1 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.

  1. Proportion of Patients With ≥30% Pain Improvement

    The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain intensity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

    Measured: Day 1, Week 12

Secondary outcomes (7)

  1. Patient's Global Impression of Change (PGIC)

    Proportion of patients with a PGIC rating of 1 ("very much improved") or 2 ("much improved") at Week 12. The PGIC is a fibromyalgia specific validated instrument on a scale of 1 to 7, where a score of 1 indicates the highest level of improvement and a score of 7 indicates the highest level of worsening.

    Measured: Week 12

  2. Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score

    The FIQR is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.

    Measured: Day 1, Week 12

  3. Change From Baseline to Week 12 in the FIQR Function Domain Score

    The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.

    Measured: Day 1, Week 12

  4. Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance

    Change from baseline in the PROMIS score for sleep disturbance at Week 12. The PROMIS Sleep disturbance short form 8a consists of 8 questions on a 5-point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less sleep disturbance.

    Measured: Day 1, Week 12

  5. Weekly Average of Daily Sleep Quality Diary

    Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12. Patients provide a daily numeric assessment of their sleep quality for the previous night, via an electronic diary, using an 11-point NRS. Scores range from 0 (best possible sleep) to 10 (worst possible sleep).

    Measured: Baseline (Day -7 to Day -1), Week 12

  6. Patient Reported Outcomes Measurement System (PROMIS) Fatigue

    Change from Baseline in the PROMIS score for fatigue at Week 12. The PROMIS fatigue short form 8a consists of 8 questions on a 5 point scale (1 to 5) where a higher score indicates a worse outcome. The total score is reported on a range of 8 to 40. Raw scores are converted to T-scores based on US population with score of 50 as average with a standard deviation of 10. Lower T-scores indicate less fatigue.

    Measured: Day 1, Week 12

  7. Weekly Average of Daily Pain Diary

    Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) NRS. Scores range from 0 (no pain) to 10 (worst possible pain).

    Measured: Baseline (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.

  1. First posted6 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

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
519 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02436096
Sponsor's protocol ID
TNX-CY-F301
Acronym
AFFIRM
Status last verified
Feb 2025
First submitted
28 Apr 2015
Last updated
7 Feb 2025
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TNX-102 SL Tablet, 2.8mg in people with Fibromyalgia and Myofascial Pain Syndromes, run by Tonix Pharmaceuticals, Inc. at 35 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 7 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 35 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 7 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?

Proportion of Patients With ≥30% Pain Improvement (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?

On the ClinicalTrials.gov record for NCT02436096.

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 7 Feb 2025.

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