A 12-Month, Multicenter, Open-Label Extension Study (F202) to Evaluate the Long-term Safety of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia
Overview
- Phase
- Phase 3
- Intervention
- TNX-102 SL
- Conditions
- Primary Fibromyalgia
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 158
- Locations
- 13
- Primary Endpoint
- Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient met all prior inclusion and exclusion requirements for Study F202 (NCT01903265) originally, and has had no intervening medical conditions, increased suicidal ideation, or requirements for concomitant medications that preclude exposure to TNX-102 SL or enrollment in the extension study.
- •The patient completed expected dosing in F202 (NCT01903265) defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on responses from daily IVRS calls recorded during the F202 study (NCT01903265)) and no major protocol violations.
- •The patient has provided written informed consent to participate in this extension protocol.
Exclusion Criteria
- Not provided
Arms & Interventions
TNX-102 SL
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
Intervention: TNX-102 SL
Outcomes
Primary Outcomes
Newly-emergent Adverse Events (NEAEs) During Treatment With TNX-102 SL Tablets Taken Daily at Bedtime Over 12 Months in Patients With Fibromyalgia.
Time Frame: Up to 12 months
NEAEs and Serious Adverse events (SAEs) were collected and are coded using the latest version of the Medical Dictionary for Regulatory Activities (MedDRA).
Secondary Outcomes
- Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall(Months 1, 3, 6, 9 and 12.)
- Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall(Month 1, 3, 6, 9, 12)
- Responder Analysis of Patient's Global Impression of Change (PGIC)(Months 1, 3, 6, 9, 12)