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A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia (AFFIRM)

Primary Purpose

Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

TNX-102 SL Tablet, 2.8mg

Placebo SL Tablet

About this trial

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

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
For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressant therapy
Willing and able to withdraw specific therapies (ask PI)
Medically acceptable form of contraception (female only)
Signed informed consent

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.
Unability to wash-out specific medications (ask PI)
Known hypersensitivity to cyclobenzaprine
Others: seizure disorders, severe/untreated sleep apnea, BMI>40

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 2.8mg 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

Average perceived pain

The primary efficacy endpoint is the proportion of patients with a ≥30% improvement (responder criteria) from baseline to Week 12 in the weekly mean of the daily self-reported 24-hour recall average pain severity score using an 11-point (0-10) NRS.

Secondary Outcome Measures

Patient's Global Impression of Change (PGIC)

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

Fibromyalgia Impact Questionnaire (FIQR)

Change from Baseline in the FIQR total score at Week12

Patient Reported Outcomes Measurement System (PROMIS)

Change from baseline in the PROMIS score for sleep disturbance 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 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

Safety of TNX-102 SL Tablets

Incidence of adverse events

Safety of TNX-102 SL Tablets assessed by changes from baseline in clinical laboratory tests

Safety of TNX-102 SL Tablets assessed by changes from baseline in vital signs

Safety of TNX-102 SL Tablets assessed by changes from baseline in physical examination findings including examination of the oral cavity

Safety of TNX-102 SL Tablets assessed by Monitoring suicidality using the C-SSRS scale

Safety of TNX-102 Sub lingual (SL) Tablets assessed by changes from baseline in BDI scores.

Full Information

NCT ID

NCT02436096

First Posted

April 28, 2015

Last Updated

December 8, 2017

Sponsor

Tonix Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02436096

Brief Title

A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

Acronym

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

December 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (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 use of low-dose CBP dosed nightly at bedtime for FM was supported by the results of Tonix' TNX-CY-F202 Phase 2b study (also referred to as the BESTFIT Study). The TNX-CY-F202 study provided strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology. The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime over 12 weeks to treat fibromyalgia.

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, Musculoskeletal Diseases, Nervous System Diseases, Neuromuscular Diseases, Rheumatic Diseases

Keywords

Pain, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

519 (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 2.8mg 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, 2.8mg

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

Average perceived pain

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Patient's Global Impression of Change (PGIC)

Description

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

Time Frame

Week 12

Title

Fibromyalgia Impact Questionnaire (FIQR)

Description

Change from Baseline in the FIQR total score at Week12

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

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 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

Title

Safety of TNX-102 SL Tablets

Description

Incidence of adverse events

Time Frame