A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Phase 3

Completed

• Conditions: Myofascial Pain Syndromes; Fibromyalgia; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases
• Interventions: Drug: TNX-102 SL Tablet, 2.8mg; Drug: Placebo SL Tablet

• Registration Number: NCT02436096
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-06
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Disposition First Submitted: 2017-12-05
• Disposition First Submitted QC: 2017-12-08
• Disposition First Posted: 2017-12-12
• Results First Submitted: 2024-08-21
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Results First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 519

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet, 2.8 mg	TNX-102 SL Tablet, 2.8mg	1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks
Placebo SL Tablet	Placebo SL Tablet	1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With ≥30% Pain Improvement	Day 1, Week 12	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).

Secondary Outcome Measures

Name	Time	Method
Patient's Global Impression of Change (PGIC)	Week 12	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.
Change From Baseline to Week 12 in the Fibromyalgia Impact Questionnaire - Revised (FIQR) Symptoms Domain Score	Day 1, Week 12	The FIQR is a validated questionnaire. Scores on the symptoms domain range from 0 to 100 where a higher score means worse outcome.
Change From Baseline to Week 12 in the FIQR Function Domain Score	Day 1, Week 12	The FIQR is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Patient Reported Outcomes Measurement System (PROMIS) Sleep Disturbance	Day 1, Week 12	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.
Weekly Average of Daily Sleep Quality Diary	Baseline (Day -7 to Day -1), Week 12	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).
Patient Reported Outcomes Measurement System (PROMIS) Fatigue	Day 1, Week 12	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.
Weekly Average of Daily Pain Diary	Baseline (Day -7 to Day -1), Week 12	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).