The purpose of the study is to evaluate whether pregabalin is effective in treating subjects who have had fibromyalgia for less than one year. Pregabalin has been approved by the FDA for treatment of fibromyalgia. the purpose of the study is to see if subjects identified through their primary care physicians who have fibromyalgia and have had symptoms for less than one year respond to pregabalin and to identify characteristics of that response.
The randomized clinical trial of pregabalin in early-onset fibromyalgia. At the baseline visit, each subject will be asked if they wish to consider enrolling in Part II. If they agree, the details of the study will be explained and Dr Goldenberg will consent those who wish to enroll in Part II. The first 75 patients who consent will be enrolled in the study, the randomized clinical trial of pregabalin in early-onset fibromyalgia. After a study subject has been enrolled, they will be randomized to one of two treatment groups. All subjects will be randomized, 1:1 either to the pregabalin group (group A) or the placebo group (group B). Randomization will take place after enrollment via selection of one of a multitude of envelopes containing a random number. Each random number will have been preassigned to either Group A or group B.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Change in pain VAS from study entry to end of study
Time frame: 12 weeks
Change in total score FIQ from study entry to last visit.
Time frame: 12 weeks
Change in total score FM 2010 Clinical Scale from study entry to last visit.
Time frame: 12 Weeks
Change in PGIC from study entry to last visit.
Time frame: 12 weeks
Change in total score for HRQOL from study entry to last visit.
Time frame: 12 Weeks
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