Conditions: Primary Fibromyalgia
Keywords: TNX-102 SL bedtime sublingual 12-month long term safety long term efficacy Fibromyalgia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 158
Healthy volunteers: no

Brief summary:
This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia. Patients recruited into this trial were those who had successfully completed the double-blind study, TNX-CY-F202 (F202) (NCT01903265). Patients were not made aware of the therapy they received during the double-blind study.

Detailed description:
The study consisted of 7 clinic visits, including Screening/Baseline Visit 1 (Day 0 which was typically the same date as Visit 6 of the double-blind lead-in study), visits after 1, 3, 6, 9, and 12 months of treatment (Visits 2-6), and a Follow-up Visit (Visit 7) scheduled within one month after stopping study drug treatment.

Primary:

The primary objective of the study was to evaluate the long-term safety of TNX-102 SL tablets taken daily at bedtime over 12 months in patients with fibromyalgia who have completed Study TNX-CY-F202 (NCT01903265)

Secondary:

The secondary objective was to evaluate the long-term efficacy of TNX-102 SL tablets taken daily at bedtime to control symptoms of fibromyalgia

Arms:
arm 1: 1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months

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

Protocol document: