12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

NCT ID: NCT02015234

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-08-31

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

Conditions

Primary Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TNX-102 SL

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

Group Type: EXPERIMENTAL

TNX-102 SL

Intervention Type: DRUG

TNX-102 SL 2.8 mg taken daily at bedtime.

Interventions

TNX-102 SL

TNX-102 SL 2.8 mg taken daily at bedtime.

Intervention Type: DRUG

Other Intervention Names

cyclobenzaprine HCl

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria

None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Sullivan

Role: STUDY_DIRECTOR

Tonix Pharmaceuticals

Locations

Denver

Denver, Colorado, United States

16176 Cortez Boulevard

Brooksville, Florida, United States

100 West Gore Street

Orlando, Florida, United States

71 Thomas Johnson Drive

Frederick, Maryland, United States

370 Faunce Corner Road

North Dartmouth, Massachusetts, United States

Worcester

Worcester, Massachusetts, United States

Jackson

Jackson, Mississippi, United States

Cincinnati

Cincinnati, Ohio, United States

1275 Olentangy River Road

Columbus, Ohio, United States

18660 Bagley Road

Middleburg Heights, Ohio, United States

1001 South Market Street

Mechanicsburg, Pennsylvania, United States

322 Memorial Drive

Greer, South Carolina, United States

601 Broadway

Seattle, Washington, United States

Countries

United States

Other Identifiers

TNX-CY-F203

Identifier Type: -

Identifier Source: org_study_id