Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain, Fibromyalgia, Neurology, Neurology, Neurology, Orthopedic, Rheumatology, Pain |
| Therapuetic Areas: | Musculoskeletal, Neurology, Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/27/2018 |
| Start Date: | July 2016 |
| 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 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.
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.
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
We found this trial at
31
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