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Trial record 7 of 22 for:    TNX-102

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02589275
Recruitment Status : Terminated (For business reason unrelated to safety or tolerability,Tonix has discontinued the Fibromyalgia development with TNX102 SL.)
First Posted : October 28, 2015
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 19, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date April 25, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
Official Title  ICMJE 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
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary Fibromyalgia
Intervention  ICMJE Drug: TNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime
Other Name: cyclobenzaprine
Study Arms  ICMJE Experimental: TNX-102 SL Tablet 2.8 mg
1x TNX-102 SL 2.8 mg sublingual tablet taken daily at bedtime for 3 months
Intervention: Drug: TNX-102 SL Tablet 2.8 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 19, 2016)
375
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2015)
1000
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589275
Other Study ID Numbers  ICMJE TNX-CY-F303
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tonix Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tonix Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP