Study of Gralise to Treat Fibromyalgia Patients

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine Gralise in treating fibromyalgia pain:

• efficacy

• safety

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Center for Clinical Research, Winston-Salem, NC
• Collaborator: Depomed
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.