A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Fibromyalgia, Neurology, Neurology, Neurology, Orthopedic, Rheumatology, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/14/2017 |
| Start Date: | April 2015 |
| End Date: | September 2016 |
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
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.
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.
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
We found this trial at
35
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials