Status:
COMPLETED
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
Lead Sponsor:
Tonix Pharmaceuticals, Inc.
Conditions:
Primary Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
TNX-102 capsules \[formerly known as very low dose (VLD) cyclobenzaprine\] at bedtime have shown promise as a treatment of fibromyalgia, but the drug required new formulation technology for bedtime us...
Eligibility Criteria
Inclusion
- Diagnosis of primary Fibromyalgia (ACR criteria)
- Male or female 18-65 years old
- For patients with major depressive disorders only: clinically stable, no suicidal risk and stable anti-depressent therapy
- Willing and able to withdraw specific therapies (ask PI)
- Medically acceptable form of contraception (female only)
- Signed informed consent
Exclusion
- 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-off specific medications (ask PI)
- Known hypersensitivity to cyclobenzaprine
- Others: seizure disorders, sleep apnea, continuous positive airway pressure (CPAP) use, BMI\>40
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01903265
Start Date
September 1 2013
End Date
September 1 2014
Last Update
December 23 2016
Active Locations (17)
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1
107 Scripps Drive
Sacramento, California, United States, 95825
2
Radiant Research, Inc.
Denver, Colorado, United States, 80239
3
16176 Cortez Boulevard
Brooksville, Florida, United States, 34601
4
100 West Gore Street
Orlando, Florida, United States, 32806