Conditions: Primary Fibromyalgia
Keywords: pain sleep
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 205
Healthy volunteers: no

Brief summary:
TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was 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: Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks. arm 2: Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.

Interventions: intervention 1: TNX-102 SL 2.8mg intervention 2: Placebo
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: