A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

April 23, 2018 updated by: Tonix Pharmaceuticals, Inc.

A 3-Month, Multicenter, Open-Label Extension to Evaluate Safety and Efficacy of TNX-102 SL Tablets Taken Daily at Bedtime in Patients With Fibromyalgia

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. Anticipated start for TNX-CY-F302 is for March 2016.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study consist of 4 study visits, including Screening/Baseline Visit 1 (Day 0, 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

Study Type

Interventional

Enrollment (Actual)

375

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
    • Arizona
      • Phoenix, Arizona, United States, 85032
    • California
      • Sacramento, California, United States, 95825
      • San Diego, California, United States, 92103
    • Florida
      • Brandon, Florida, United States, 33511
      • DeLand, Florida, United States, 32720
      • Lakeland, Florida, United States, 33805
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32806
      • Tampa, Florida, United States, 33614
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Columbus, Georgia, United States, 31904
      • Smyrna, Georgia, United States, 30080
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • New York
      • Williamsville, New York, United States, 14221
    • Ohio
      • Cincinnati, Ohio, United States, 45206
      • Middleburg Heights, Ohio, United States, 44130
    • Oregon
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
    • Rhode Island
      • Warwick, Rhode Island, United States, 02888
    • South Carolina
      • Greer, South Carolina, United States, 29650
      • Mount Pleasant, South Carolina, United States, 29464
    • Texas
      • Dallas, Texas, United States, 75231
    • Utah
      • Salt Lake City, Utah, United States, 84102
    • Virginia
      • Charlottesville, Virginia, United States, 22911
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Bellevue, Washington, United States, 98007
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient met all prior inclusion and exclusion requirements for study F301 or F302 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 F301 or F302 defined as taking study medication up to Week 12, with at least 70% compliance with medication usage (based on overall drug accountability reconciliation at the end of the F301 or F302 lead-in study) and no major protocol deviations.
  • The patient has provided written informed consent to participate in this extension protocol.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TNX-102 SL Tablet 2.8 mg
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months
Drug: TNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Other Names:
  • cyclobenzaprine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety will be assessed by AEs, clinical laboratory tests, vital signs, physical examination, oral cavity examinations, Columbia C-SSRS scale, and depression status using the BDI.
Time Frame: 3 months
Safety will be assessed by the monitoring and recording of AEs, clinical laboratory tests, vital signs, physical examination findings including oral cavity examinations, the monitoring of suicidality using the Columbia C-SSRS scale, and depression status using the BDI.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: 24-hour and 7-day recall assessments of the pain of FM using an in-clinic 11-point (0-11) NRS administered at Months 1, 2 and 3
Time Frame: 1, 2 and 3 months
24-hour and 7-day recall assessments of the pain of FM using an in-clinic 11-point (0-11) NRS administered at Months 1, 2 and 3
1, 2 and 3 months
Efficacy: Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3
Time Frame: 1, 2 and 3 months
Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3
1, 2 and 3 months
Efficacy: Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3
Time Frame: 1, 2 and 3 months
Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3
1, 2 and 3 months
Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3
Time Frame: 1, 2 and 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3
1, 2 and 3 months
Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3
Time Frame: 1, 2 and 3 months
Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3
1, 2 and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tonix Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 19, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 23, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNX-CY-F303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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