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Completed

NCT Number: NCT02015234

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

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.

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Key information

Conditions

Primary Fibromyalgia Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Denver, Colorado, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

None

Treatment and study plan

TNX-102 SL

Drug

TNX-102 SL 2.8 mg taken daily at bedtime.

Other names: cyclobenzaprine HCl

Primary outcomes

  1. 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

  1. Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on 24 Hour Recall

    Time frame: Months 1, 3, 6, 9 and 12.

    The NRS for average pain was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 24-hour recall basis.

  2. Change From Baseline in Numerical Rating Scale (NRS) Assessments of Average Pain Based on a 7 Day Recall

    Time frame: Month 1, 3, 6, 9, 12

    The NRS for average pain over the past 7 days was an 11-point scale (0=no pain → 10=worst pain imaginable) that was assessed on a 7-day recall basis.

  3. Responder Analysis of Patient's Global Impression of Change (PGIC)

    Time frame: Months 1, 3, 6, 9, 12

    PGIC is a fibromyalgia-specific validated instrument to gauge the patient's assessment of change in condition.The scores are categorized as provided below. A responder was defined by a score of 1 (very much improved), or 2 (much improved).

    • = Very much improved
    • = Much improved
    • = Minimally improved
    • = No change
    • = Minimally worse
    • = Much worse
    • = Very much worse

Sponsors and collaborators

Lead sponsor

Tonix Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Acronym: BESTFIT-OLE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Jul 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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