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Trial record 32 of 47 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT02015234
Recruitment Status : Completed
First Posted : December 19, 2013
Results First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Primary Fibromyalgia Drug: TNX-102 SL Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 158 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : December 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TNX-102 SL
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 12 months
Drug: TNX-102 SL
TNX-102 SL 2.8 mg taken daily at bedtime.
Other Name: cyclobenzaprine HCl




Primary Outcome Measures :
  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 Outcome Measures :
  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).

    1. = Very much improved
    2. = Much improved
    3. = Minimally improved
    4. = No change
    5. = Minimally worse
    6. = Much worse
    7. = Very much worse



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02015234


Locations
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United States, Colorado
Denver
Denver, Colorado, United States, 80239
United States, Florida
16176 Cortez Boulevard
Brooksville, Florida, United States, 34601
100 West Gore Street
Orlando, Florida, United States, 32806
United States, Maryland
71 Thomas Johnson Drive
Frederick, Maryland, United States, 21702
United States, Massachusetts
370 Faunce Corner Road
North Dartmouth, Massachusetts, United States, 02747
Worcester
Worcester, Massachusetts, United States, 01605
United States, Mississippi
Jackson
Jackson, Mississippi, United States, 39202
United States, Ohio
Cincinnati
Cincinnati, Ohio, United States, 45219
1275 Olentangy River Road
Columbus, Ohio, United States, 43212
18660 Bagley Road
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
1001 South Market Street
Mechanicsburg, Pennsylvania, United States, 17055
United States, South Carolina
322 Memorial Drive
Greer, South Carolina, United States, 29650
United States, Washington
601 Broadway
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Gregory Sullivan Tonix Pharmaceuticals

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02015234     History of Changes
Other Study ID Numbers: TNX-CY-F203
First Posted: December 19, 2013    Key Record Dates
Results First Posted: July 7, 2017
Last Update Posted: July 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Tonix Pharmaceuticals, Inc.:
TNX-102 SL
bedtime
sublingual
12-month
long term safety
long term efficacy
Fibromyalgia
Additional relevant MeSH terms:
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Cyclobenzaprine
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants