Study of Gralise to Treat Fibromyalgia Patients — Gralise  

Fibromyalgia Clinical Trial

Official title: Open Labeled, Non-randomized, Study of Efficacy and Safety of Gralise in Fibromyalgia Patients.

Status Completed

Clinical Trial Summary

To determine Gralise in treating fibromyalgia pain:

• efficacy

• safety

Clinical Trial Description

Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia

• Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name: Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack of efficacy.

• Patient who had allergic reaction or serious adverse reactions will not be included in this study.

• Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800 mg per day by end of 2 weeks.

• Drug is to be taken with meal, once a day in the evening; once patient has reached the therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will evaluate the patient and may increase or decrease the dosage, but patient may not increase or decrease the dose of medication at his /her discretion.

• During study, patient will have total of 5 visits, 4 of which will be for duration patient will be on Gralise, and the last visit will be for tapering off the medication.

• During study, patient is asked keep a paper diary on which patient will record the numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication, and any side effects. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

• NCT number: NCT02052414
• Study type: Interventional
• Source: The Center for Clinical Research, Winston-Salem, NC
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Completion date: November 2013