Conditions: Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Musculoskeletal Diseases
Keywords: Pain Sleep Fibromyalgia FM
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 51
Healthy volunteers: no

Brief summary:
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

Detailed description:

Arms:
arm 1: 1 x TNX-102 SL 2.8 mg 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, 2.8 mg 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 0 for 12 weeks. intervention 2: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Protocol document: