Study of Gralise to Treat Fibromyalgia Patients
Completed · Not applicable
Conditions studied: Fibromyalgia
In brief
To determine Gralise in treating fibromyalgia pain: * efficacy * safety
Key facts
- Study ID
- NCT02052414
- Run by
- The Center for Clinical Research, Winston-Salem, NC
- People needed
- 34
- Starts
- 2012-07-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2016-10-19
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject must be 18 years and older.
- Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
- Fibromyalgia patients who are gamma-aminobutyric acid (GABA)-analogue (gabapentin or pregabalin) naïve, or those who have been on gamma-aminobutyric acid (GABA)-analogue, but discontinued due to side effects or having difficulty maintaining dosing schedule due to multiple doses per day, or those who are currently on immediate release gamma-aminobutyric acid-analogue (GABA).
- Able to distinguish pain from fibromyalgia and pain from other sources. (subjects with other rheumatic disease or medical conditions that contributed to the symptoms of fibromyalgia will be excluded)
- Subject pain scores >4 on Numeric pain rating scale (NPRS)
You may not qualify if…
- Creatinine clearance of < 30mg/ml
- Pain from Traumatic injury or structural or regional rheumatic disease
- Unstable medical or psychiatric illness
- Lifetime history of psychosis, hypomania, or mania.
- Epilepsy, or dementia
- Substance abuse in the last 6 months
- Suicidal tendencies
- Pregnant or breastfeeding
- Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
- Subjects who are, in the opinion of the principle investigator, are treatment refractory
- Treatment with investigational drug within 30 days of screening.
- Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
- Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.
Where it is running
- Center for Clinical Research — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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