A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

Phase 3

Completed

• Conditions: Fibromyalgia
• Interventions: Drug: TNX-102 SL Tablet, 5.6 mg; Drug: Placebo SL Tablet

• Registration Number: NCT05273749
• Lead Sponsor: Tonix Pharmaceuticals, Inc.

Brief Summary

This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-04-06
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Results First Submitted: 2024-11-26
• Results First Submitted QC: 2024-11-26
• Results First Posted: 2024-12-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

Inclusion Criteria

• The patient is male or female 18 to 65 years of age, inclusive.
• The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)

Exclusion Criteria

• The patient has been diagnosed with infectious or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis), systemic lupus erythematosus, untreated or active gout (ie, any acute attacks within past 2 years is exclusionary), or meets criteria for other type of systemic autoimmune disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNX-102 SL Tablet, 5.6 mg	TNX-102 SL Tablet, 5.6 mg	1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks, then 2 x TNX-102 SL 2.8 mg (5.6 mg) 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 2 weeks, then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline to the Week 14 Endpoint in the Diary NRS Weekly Average of Daily Self Reported Average Pain Severity Scores.	Baseline (Day -7 to Day -1), Week 14	Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients With a Patient's Global Impression of Change (PGIC) Rating of "Very Much Improved" or "Much Improved" at the Week 14 Endpoint	Week 14	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 a much worse outcome.
Change From Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) Symptoms Domain Score at the Week 14 Endpoint	Day 1, Week 14	Change from Baseline in the FIQ-R Symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.
Change From Baseline in the FIQ-R Function Domain Score at the Week 14 Endpoint	Day 1, Week 14	The FIQ-R is a validated questionnaire. Scores on the function domain range from 0 to 90 where a higher score means worse outcome.
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Score for Sleep Disturbance at the Week 14 Endpoint	Day 1, Week 14	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.
Change From Baseline in the PROMIS Score for Fatigue at the Week 14 Endpoint	Day 1, Week 14	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.
Change From Baseline in the Weekly Average of the Daily Diary Assessment of Sleep Quality at the Week 14 Endpoint	Baseline (Day -7 to Day -1), Week 14	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).

Trial Locations

Locations (1)

Tonix Clinical Site; 🇺🇸 Kenosha, Wisconsin, United States