NCT02829814Phase 3Terminated

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Study sponsor: Tonix Pharmaceuticals, Inc.

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2016-09-13Actual

Enrollment · participants51Actual

Source updated2025-02-25Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases; Musculoskeletal Diseases

Treatments or interventions studied

TNX-102 SL Tablet, 2.8 mgDrugAlso known as Low dose cyclobenzaprine sublingual tablets
Placebo SL TabletDrugAlso known as Placebo sublingual tablets

Primary outcomes · main study measures

Read the study measures

measure: Weekly Mean Pain Score; description: 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".; timeFrame: Day 1, Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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