Clinical trials: Fibromyalgia, Primary
Primary Fibromyalgia
A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients
This is a Phase 3, open-label, extension trial designed to evaluate the long term safety and efficacy over 3 months of TNX-102 SL tablets taken daily at bedtime for the treatment of Fibromyalgia (FM).
- Trial name
- NCT02589275
- Testing
- TNX-102 SL Tablet 2.8 mg
- Where
- 33 sites in United States
- Volunteers
- 375 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Primary Fibromyalgia
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
- Trial name
- MyFi (NCT01328002)
- Testing
- Milnacipran
- Where
- 47 sites in United States
- Volunteers
- 116 people
- Sponsor
- Forest Laboratories
Primary Fibromyalgia
12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients
This was an open-label, extension trial designed to evaluate the long-term safety over 12 months of TNX-102 SL tablets taken daily at bedtime for the treatment of fibromyalgia.
- Trial name
- BESTFIT-OLE (NCT02015234)
- Testing
- TNX-102 SL
- Where
- 13 sites in United States
- Volunteers
- 158 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Juvenile Primary Fibromyalgia Syndrome (JPFS), Fibromyalgia
Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia
The purpose of this research is to conduct an open, pilot trial to assess the efficacy and safety of fluoxetine in the treatment of Juvenile Primary Fibromyalgia Syndrome (JPFS).
- Trial name
- NCT00115804
- Testing
- Fluoxetine
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Cincinnati
Primary Fibromyalgia
BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)
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 use.
- Trial name
- BESTFIT (NCT01903265)
- Testing
- TNX-102 SL 2.8mg
- Where
- 17 sites in United States
- Volunteers
- 205 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Fibromyalgia, Primary
An Eight Week, Double-Blind Efficacy Study of Armodafinil Augmentation to Alleviate Fibromyalgia Fatigue
Armodafinil (NuvigilTM) is an isomer of a drug currently approved by the FDA for the treatment of fatigue secondary to narcolepsy, sleep apnea, and shift work sleep disorder called modafinil (ProvigilTM).
- Trial name
- NCT00678691
- Testing
- armodafinil
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- State University of New York - Upstate Medical University
Primary Fibromyalgia
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
- Trial name
- MyFi (NCT01331109)
- Testing
- Milnacipran
- Where
- 31 sites in United States
- Volunteers
- 57 people
- Sponsor
- Forest Laboratories
Fibromyalgia, Primary, Fibromyalgia, Secondary
A Study for Adult Patients With Fibromyalgia
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
- Trial name
- HMGG (NCT00965081)
- Testing
- Duloxetine
- Where
- 4 sites in Mexico
- Volunteers
- 308 people
- Sponsor
- Eli Lilly and Company