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A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia (RALLY)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508621
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE August 7, 2020
First Posted Date  ICMJE August 11, 2020
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Mean Pain Score [ Time Frame: Week 14 ]
Change from Baseline to the Week 14 endpoint in the diary Numerical Rating Scale (NRS) weekly average of daily self-reported average pain severity scores. Scores range from 0 to 10 where a higher score means worse outcome.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
Fibromyalgia Impact Questionnaire - Revised (FIQ-R) [ Time Frame: Week 14 ]
Change from Baseline in the Fibromyalgia Impact Questionnaire - Revised (FIQ-R) symptoms domain score at the Week 14 endpoint. Scores on the symptoms domain range from 0 to 90 where a higher score means worse outcome.
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 Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Official Title  ICMJE A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of TNX-102 SL Taken Daily At Bedtime In Patients With Fibromyalgia
Brief Summary This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of fibromyalgia.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Drug: TNX-102 SL
    Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
    Other Name: Low dose cyclobenzaprine sublingual tablets
  • Drug: Placebo SL Tablet
    Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
    Other Name: Placebo sublingual tablets
Study Arms  ICMJE
  • Experimental: TNX-102 SL Tablet, 2.8 mg
    1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 2 weeks then 2 x TNX-102 SL 2.8 mg (5.6 mg) Tablet taken sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: TNX-102 SL
  • Placebo Comparator: Placebo SL Tablet
    1 x Placebo Tablet taken sublingually each day at bedtime for 2 weeks then 2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: Placebo SL Tablet
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2020)
470
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patient is male or female 18 to 65 years of age, inclusive.
  • The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary Diagnostic Criteria)
  • The in clinic 7-day recall NRS average daily pain intensity score at Screening Visit within protocol defined range.

Exclusion Criteria:

- History of or evidence for a diagnosis of borderline personality disorder (BPD).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mary Kelley, MPH 6193955767 mary.kelley@tonixpharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04508621
Other Study ID Numbers  ICMJE TNX-CY-F306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tonix Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tonix Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Sullivan, MD Tonix Pharmaceuticals, Inc.
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date October 2020

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