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

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436096
• Other study ID #: TNX-CY-F301
• Status: Completed
• Phase: Phase 3
• First received: April 28, 2015
• Last updated: December 8, 2017
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 519
• 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:

• 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

Related Conditions & MeSH terms

• Collagen Diseases
• Fibromyalgia
• Muscular Diseases
• Musculoskeletal Diseases
• Myofascial Pain Syndromes
• Nervous System Diseases
• Neuromuscular Diseases
• Rheumatic Diseases

Intervention

Drug:
• TNX-102 SL Tablet, 2.8mg
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
• Placebo SL Tablet
Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

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	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.	Week 12
Secondary	Patient's Global Impression of Change (PGIC)	Proportion of patients with a PGIC of "very much improved" or "much improved" rating at Week 12	Week 12
Secondary	Fibromyalgia Impact Questionnaire (FIQR)	Change from Baseline in the FIQR total score at Week12	Week 12
Secondary	Patient Reported Outcomes Measurement System (PROMIS)	Change from baseline in the PROMIS score for sleep disturbance at Week 12	Week 12
Secondary	Daily Diary sleep	Change from Baseline in the weekly average of the daily diary assessment of sleep quality at Week 12	Week 12
Secondary	Patient Reported Outcomes Measurement System (PROMIS)	Change from Baseline in the PROMIS score for fatigue at Week 12	Week 12
Secondary	Daily Diary pain	Change from baseline to Week 12 in the weekly average of the daily self-reported average pain severity score	Week 12
Secondary	Safety of TNX-102 SL Tablets	Incidence of adverse events	Continuously throughout the treatment period (total duration: about 3 months)
Secondary	Safety of TNX-102 SL Tablets assessed by changes from baseline in clinical laboratory tests		Continuously throughout the treatment period (total duration: about 3 months)
Secondary	Safety of TNX-102 SL Tablets assessed by changes from baseline in vital signs		Continuously throughout the treatment period (total duration: about 3 months)
Secondary	Safety of TNX-102 SL Tablets assessed by changes from baseline in physical examination findings including examination of the oral cavity		Continuously throughout the treatment period (total duration: about 3 months)
Secondary	Safety of TNX-102 SL Tablets assessed by Monitoring suicidality using the C-SSRS scale		Continuously throughout the treatment period (total duration: about 3 months)
Secondary	Safety of TNX-102 Sub lingual (SL) Tablets assessed by changes from baseline in BDI scores.		Continuously throughout the treatment period (total duration: about 3 months)