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

NCT ID: NCT01903265

Last Updated: 2016-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Fibromyalgia

Keywords

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pain sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TNX-102 SL 2.8 mg

Patients will take 1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks.

Group Type EXPERIMENTAL

TNX-102 SL 2.8mg

Intervention Type DRUG

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

Placebo

Patients will take 1 tablet of placebo sublingually each day at bedtime for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Low dose cyclobenzaprine sublingual tablets Placebo sublingual tablets

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of primary Fibromyalgia (ACR criteria)
* Male or female 18-65 years old
* For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
* Willing and able to withdraw specific therapies (ask PI)
* Medically acceptable form of contraception (female only)
* Signed informed consent

Exclusion Criteria

* Arthritis, lupus and other systemic auto-immune diseases
* Regional or persistent pain that could interfere with assessment of fibromyalgia pain
* Bipolar and psychotic disorders
* Increased risk of suicide
* Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
* Inability to wash-off specific medications (ask PI)
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI\>40
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tonix Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark R. Schmal

Role: STUDY_DIRECTOR

Premier Research

Daniel J. Clauw, MD

Role: STUDY_CHAIR

Ann Arbor, MI

Locations

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107 Scripps Drive

Sacramento, California, United States

Site Status

Radiant Research, Inc.

Denver, Colorado, United States

Site Status

16176 Cortez Boulevard

Brooksville, Florida, United States

Site Status

100 West Gore Street

Orlando, Florida, United States

Site Status

3401 North Central Avenue

Chicago, Illinois, United States

Site Status

71 Thomas Johnson Drive

Frederick, Maryland, United States

Site Status

370 Faunce Corner Road

North Dartmouth, Massachusetts, United States

Site Status

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States

Site Status

CRC of Jackson, LLC

Jackson, Mississippi, United States

Site Status

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Site Status

1275 Olentangy River Road

Columbus, Ohio, United States

Site Status

18660 Bagley Road

Middleburg Heights, Ohio, United States

Site Status

1001 South Market Street

Mechanicsburg, Pennsylvania, United States

Site Status

322 Memorial Drive

Greer, South Carolina, United States

Site Status

1002 E. South Temple

Salt Lake City, Utah, United States

Site Status

1951 152nd Place NE

Bellevue, Washington, United States

Site Status

601 Broadway

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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TNX-CY-F202

Identifier Type: -

Identifier Source: org_study_id