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

Fibromyalgia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02829814
• Other study ID #: TNX-CY-F302
• Status: Terminated
• Phase: Phase 3
• First received: July 8, 2016
• Last updated: April 23, 2018
• Start date: July 2016
• 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• 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

• 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

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, 2.8 mg
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
Other	Safety of TNX-102 SL Tablets (Incidence of Adverse Events)	Incidence of Adverse Events	Continuously throughout the treatment period (total duration: about 3 months)
Other	Safety of TNX-102 SL Tablets (Changes from Baseline in clinical laboratory tests)	Changes from Baseline in clinical laboratory tests	Continuously throughout the treatment period (total duration: about 3 months)
Other	Safety of TNX-102 SL Tablets (Changes from Baseline in vital signs)	Changes from Baseline in vital signs	Continuously throughout the treatment period (total duration: about 3 months)
Other	Safety of TNX-102 SL Tablets (Changes from Baseline in physical examination findings including examination of the oral cavity)	Changes from Baseline in physical examination findings including examination of the oral cavity	Continuously throughout the treatment period (total duration: about 3 months)
Other	Safety of TNX-102 SL Tablets (Monitoring suicidality using the C-SSRS)	Monitoring suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)	Continuously throughout the treatment period (total duration: about 3 months)
Other	Safety of TNX-102 SL Tablets (Changes from Baseline in BDI-II scores)	Changes from Baseline in Beck Depression Inventory Scores (BDI-II) scores	Continuously throughout the treatment period (total duration: about 3 months)
Primary	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).	Week 12
Secondary	Patient's Global Impression of Change (PGIC)	Proportion of patients with a PGIC rating of "very much improved" or "much improved" at Week 12	Week 12
Secondary	Fibromyalgia Impact Questionnaire (FIQR) Revised	Change from Baseline in the FIQR symptoms domain score at Week 12	Week 12
Secondary	Fibromyalgia Impact Questionnaire (FIQR) Revised	Change from Baseline in the FIQR function domain score 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 sleep disturbance 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