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

Primary Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02589275
• Other study ID #: TNX-CY-F303
• Status: Terminated
• Phase: Phase 3
• First received: October 19, 2015
• Last updated: April 23, 2018
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 375
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Primary Fibromyalgia

Intervention

Drug:
• TNX-102 SL Tablet 2.8 mg
TNX-102 SL 2.8 mg tablet taken daily at bedtime

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 months
Secondary	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	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	1, 2 and 3 months
Secondary	Efficacy: Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3	Patient's Global Impression of Change (PGIC) at Months 1, 2 and 3	1, 2 and 3 months
Secondary	Efficacy: Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3	Fibromyalgia Impact Questionnaire - Revised (FIQR) total, individual domain and item scores at Months 1, 2 and 3	1, 2 and 3 months
Secondary	Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3	Patient Reported Outcomes Measurement Information System (PROMIS) scale for fatigue at Months 1, 2 and 3	1, 2 and 3 months
Secondary	Efficacy: Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3	Patient Reported Outcomes Measurement Information System (PROMIS) scale for sleep disturbance at Months 1, 2 and 3	1, 2 and 3 months