Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL bedtime sublingual 3-month long term safety long term efficacy Fibromyalgia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 375
Healthy volunteers: no

Brief summary:
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM). Patients recruits into this trial are those who have successfully completed the double-blind studies; TNX-CY-F301 and TNX-CY-F302.

Patients will not be made aware of the therapy they received during the double-blind study.

Detailed description:
The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 1, which is anticipated to be the same date as Visit 6 in F301 or F302) and visits after 1, 2 and 3 months of treatment (Visits 2-4).

Primary:

The primary objective of the study is to evaluate the safety of TNX-102 SL tablets taken daily at bedtime over an additional 3 months in patients with FM who have completed the double-blinded lead-in study

Secondary:

The secondary objective is to evaluate the efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of FM

Arms:
arm 1: 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months

Interventions: intervention 1: TNX-102 SL Tablet 2.8 mg
Intervention descriptions: intervention 1: TNX-102 SL 2.8 mg tablet taken daily at bedtime

Protocol document: