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BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

NCT01903265 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2016-12-23

Study results available
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Summary

TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime use. The present trial was designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

Conditions

  • Primary Fibromyalgia

Interventions

DRUG

TNX-102 SL 2.8mg

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

DRUG

Placebo

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark R. Schmal · Premier Research

  • Daniel J. Clauw, MD · Ann Arbor, MI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903265 on ClinicalTrials.gov