Overview

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.