Conditions: Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases
Keywords: Pain Sleep
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 519
Healthy volunteers: no

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:

Arms:
arm 1: 1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks arm 2: 1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Interventions: intervention 1: TNX-102 SL Tablet, 2.8mg intervention 2: Placebo SL Tablet
Intervention descriptions: intervention 1: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks. intervention 2: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 1 for 12 weeks.

Protocol document: