Clinical trials: Fibromyalgia Pain
Fibromyalgia
Trial Comparing the Effects of Xyrem (Sodium Oxybate) With Placebo for the Treatment of Fibromyalgia
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
- Trial name
- NCT00087555
- Testing
- Xyrem (sodium oxybate) oral solution
- Where
- 20 sites in United States
- Volunteers
- 195 people
- Sponsor
- Jazz Pharmaceuticals
Pain Associated With Fibromyalgia
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Pregabalin on Fibromyalgia patients related to their appropriate use in daily practice.
- Trial name
- NCT01773993
- Testing
- Pregabalin
- Volunteers
- 534 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Pain Associated With Fibromyalgia
An Open-Label Extension Study of DS-5565 for 52 Weeks in Pain Associated With Fibromyalgia
This is an open-label study of DS-5565 in subjects who either completed participation in a preceding Phase 3 study of DS-5565 in fibromyalgia (FM); i.e.
- Trial name
- NCT02234583
- Testing
- DS-5565
- Where
- 276 sites in United States, Australia and 27 more
- Volunteers
- 2,485 people
- Sponsor
- Daiichi Sankyo
Epilepsy, Neuropathic Pain
Lyrica (Pregabalin) Korean Post Marketing Surveillance Study
This study collects post-marketing safety and efficacy surveillance data in real world clinical use of pregabalin for its approved indications in Korea.
- Conditions
- Epilepsy, Neuropathic Pain, Fibromyalgia, Post-market Surveillance
- Trial name
- NCT01220180
- Testing
- pregabalin (Lyrica)
- Volunteers
- 4,175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Fibromyalgia
Safety and Efficacy of AGN 203818 for Pain Associated With Fibromyalgia Syndrome
This study will explore the safety and effectiveness of different doses of AGN 203818 in treating the pain associated with fibromyalgia syndrome. The study is being conducted in 2 parts.
- Trial name
- NCT00445705
- Testing
- AGN 203818
- Where
- 3 sites in United States, Switzerland and 1 more
- Volunteers
- 211 people
- Sponsor
- Allergan
Fibromyalgia
Safety Study of DS-5565 for Treatment of Fibromyalgia Pain in Subjects With Chronic Kidney Disease
DS-5565 (mirogabalin) is being studied as treatment for fibromyalgia (FM) pain. Because it is excreted through the kidneys, people who have reduced kidney function will not process the drug as well as with those with normal…
- Trial name
- NCT02496884
- Testing
- DS-5565
- Where
- 39 sites in United States, Bulgaria and 6 more
- Volunteers
- 56 people
- Sponsor
- Daiichi Sankyo
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
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of…
- Trial name
- RELIEF (NCT04172831)
- Testing
- TNX-102 SL
- Where
- 39 sites in United States
- Volunteers
- 503 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Fibromyalgia
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
The purpose of this study is to evaluate the efficacy and safety of a controlled release formulation of pregabalin administered once daily as compared to placebo in the treatment of fibromyalgia.
- Trial name
- NCT01271933
- Testing
- pregabalin
- Where
- 52 sites in United States, Canada and 2 more
- Volunteers
- 441 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Fibromyalgia
A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) taken daily at bedtime for the treatment of…
- Trial name
- RALLY (NCT04508621)
- Testing
- TNX-102 SL
- Where
- 36 sites in United States
- Volunteers
- 514 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
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
Pain Associated With Fibromyalgia
Treatment of Pain Associated With Fibromyalgia
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in subjects receiving either dose of DS-5565 versus placebo.
- Trial name
- NCT02146430
- Testing
- DS-5565, Pregabalin
- Where
- 165 sites in United States, Canada and 9 more
- Volunteers
- 1,293 people
- Sponsor
- Daiichi Sankyo
Fibromyalgia, Myofascial Pain Syndromes
Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken 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.
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Nervous System Diseases
- Trial name
- RE-AFFIRM (NCT02829814)
- Testing
- TNX-102 SL Tablet, 2.8 mg
- Where
- 32 sites in United States
- Volunteers
- 51 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Fibromyalgia
Effect of Milnacipran on Pain Processing and Functional Magnetic Resonance Imaging (fMRI) Activation Patterns in Patients With Fibromyalgia
The purpose of this study is to evaluate the effect of milnacipran on how the brain processes pain in patients with fibromyalgia and to assess the relationship between this effect and brain activation patterns during functional…
- Trial name
- NCT00793520
- Testing
- Milnacipran
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Forest Laboratories
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
Fibromyalgia, Myofascial Pain Syndromes
A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken 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).
- Conditions
- Fibromyalgia, Myofascial Pain Syndromes, Muscular Diseases, Musculoskeletal Diseases
- Trial name
- AFFIRM (NCT02436096)
- Testing
- TNX-102 SL Tablet, 2.8mg
- Where
- 35 sites in United States
- Volunteers
- 519 people
- Sponsor
- Tonix Pharmaceuticals, Inc.
Pain Associated With Fibromyalgia
Treatment of Pain Associated With Fibromyalgia
The main objective of this trial is to compare change in weekly average daily pain score (ADPS) from baseline to Week 13 in participants receiving either dose of DS-5565 versus placebo.
- Trial name
- NCT02187471
- Testing
- DS-5565, Pregabalin
- Where
- 154 sites in United States, Argentina and 12 more
- Volunteers
- 1,301 people
- Sponsor
- Daiichi Sankyo
Fibromyalgia
A Safety and Efficacy Study of Xyrem® (Sodium Oxybate) to Treat Fibromyalgia.
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
- Trial name
- NCT00423813
- Testing
- Xyrem®
- Where
- 116 sites in United States, France and 6 more
- Volunteers
- 573 people
- Sponsor
- Jazz Pharmaceuticals
Fibromyalgia
A Safety and Efficacy Study of Xyrem® in Subjects With Fibromyalgia
The objective of this trial is to evaluate the safety and efficacy of Xyrem® compared to placebo for the treatment of fibromyalgia in a randomized, double blind, placebo controlled, parallel group trial.
- Trial name
- NCT00371137
- Testing
- Xyrem®
- Where
- 70 sites in United States
- Volunteers
- 548 people
- Sponsor
- Jazz Pharmaceuticals
Fibromyalgia
An fMRI Study Of Brain Response In Patients With Fibromyalgia
The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether…
- Trial name
- NCT00760474
- Where
- 2 sites in United States
- Volunteers
- 27 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.