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

• ClinicalTrials.gov Identifier: NCT02589275
• Recruitment Status: Terminated
• First Posted: October 28, 2015
• Last Update Posted: April 25, 2018
• Sponsor: Tonix Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Tonix Pharmaceuticals, Inc.

Tracking Information

• First Submitted Date: October 19, 2015
• First Posted Date: October 28, 2015
• Last Update Posted Date: April 25, 2018
• Study Start Date: August 2015
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Primary Fibromyalgia

Intervention

Drug: TNX-102 SL Tablet 2.8 mg

TNX-102 SL 2.8 mg tablet taken daily at bedtime

Other Name: cyclobenzaprine

Study Arms

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 19, 2016): 375
• Original Estimated Enrollment (submitted: October 26, 2015): 1000
• Actual Study Completion Date: September 2016
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02589275
• Other Study ID Numbers: TNX-CY-F303
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Tonix Pharmaceuticals, Inc.
• Study Sponsor: Tonix Pharmaceuticals, Inc.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Tonix Pharmaceuticals, Inc.
• Verification Date: April 2018