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Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia (RE-AFFIRM)

Primary Purpose

Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

TNX-102 SL Tablet, 2.8 mg

Placebo SL Tablet

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pain, Sleep, Fibromyalgia, FM

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Primary Fibromyalgia (2010 ACR criteria)
Male or female 18-75 years old
Patients currently receiving pharmacologic treatment for depression should have been clinically stable for at least 3 months prior to randomization, and on stable doses of antidepressants during this 3 month time frame.
Willing and able to withdraw specific therapies (ask PI)
If female, medically acceptable form of contraception or not of child bearing potential.
Provide written informed consent to participate.
Willing and able to comply with all protocol specified requirement.

Exclusion Criteria:

Arthritis, lupus and other systemic auto-immune diseases
Regional or persistent pain that could interfere with assessment of fibromyalgia pain
Bipolar and psychotic disorders
Increased risk of suicide
Significant clinical (cardiac, systemic infection, systemic corticosteroid requirement, drug/alcohol abuse) or laboratory abnormalities.
Inability to wash-out specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, severe/untreated sleep apnea, BMI>45

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNX-102 SL Tablet, 2.8 mg

Placebo SL Tablet

Arm Description

1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks

1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Outcomes

Primary Outcome Measures

Weekly mean pain score

The primary efficacy endpoint is the proportion of patients with a ≥30% improvement from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score using an 11-point (0-10) numeric response scale (NRS).

Secondary Outcome Measures

Patient's Global Impression of Change (PGIC)

Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12

Fibromyalgia Impact Questionnaire (FIQR) Revised

Change from Baseline in the FIQR symptoms domain score at Week 12

Fibromyalgia Impact Questionnaire (FIQR) Revised

Change from Baseline in the FIQR function domain score at Week 12

Daily Diary Sleep

Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12

Patient Reported Outcomes Measurement System (PROMIS)

Change from Baseline in the PROMIS score for sleep disturbance at Week 12

Patient Reported Outcomes Measurement System (PROMIS)

Change from Baseline in the PROMIS score for fatigue at Week 12

Daily Diary Pain

Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score

Full Information

NCT ID

NCT02829814

First Posted

July 8, 2016

Last Updated

April 23, 2018

Sponsor

Tonix Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02829814

Brief Title

Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

Acronym

RE-AFFIRM

Official Title

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study To Evaluate The EFFIcacy and Safety of TNX-102 SL Tablets Taken Daily At Bedtime In Patients With FibRoMyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Terminated

Why Stopped

For business reason unrelated to safety or tolerability,Tonix has discontinued the Fibromyalgia development with TNX102 SL.

Study Start Date

July 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tonix Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia. The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases, Musculoskeletal Diseases

Keywords

Pain, Sleep, Fibromyalgia, FM

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TNX-102 SL Tablet, 2.8 mg

Arm Type

Experimental

Arm Description

1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks

Arm Title

Placebo SL Tablet

Arm Type

Placebo Comparator

Arm Description

1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks

Intervention Type

Drug

Intervention Name(s)

TNX-102 SL Tablet, 2.8 mg

Other Intervention Name(s)

Low dose cyclobenzaprine sublingual tablets

Intervention Description

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo SL Tablet

Other Intervention Name(s)

Placebo sublingual tablets

Intervention Description

Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Primary Outcome Measure Information:

Title

Weekly mean pain score

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Patient's Global Impression of Change (PGIC)

Description

Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12

Time Frame

Week 12

Title

Fibromyalgia Impact Questionnaire (FIQR) Revised

Description

Change from Baseline in the FIQR symptoms domain score at Week 12

Time Frame

Week 12

Title

Fibromyalgia Impact Questionnaire (FIQR) Revised

Description

Change from Baseline in the FIQR function domain score at Week 12

Time Frame

Week 12

Title

Daily Diary Sleep

Description

Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12

Time Frame

Week 12

Title

Patient Reported Outcomes Measurement System (PROMIS)

Description

Change from Baseline in the PROMIS score for sleep disturbance at Week 12

Time Frame

Week 12

Title

Patient Reported Outcomes Measurement System (PROMIS)

Description

Change from Baseline in the PROMIS score for fatigue at Week 12

Time Frame

Week 12

Title

Daily Diary Pain

Description

Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score

Time Frame

Week 12

Other Pre-specified Outcome Measures:

Title

Safety of TNX-102 SL Tablets (Incidence of Adverse Events)

Description

Incidence of Adverse Events

Time Frame