Fibromyalgia of Less Than One Year Duration. Study of Pregabalin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Fibromyalgia of Less Than One Year Duration in Primary Care: Treatment Response in a Double Blind, Placebo Controlled Study of Pregabalin

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Meet the 2010 ACR criteria for diagnosis of fibromyalgia (See Appendix) Meet the 1990 ACR criteria for the classification of fibromyalgia (See Appendix) Patients have a pain VAS > 4 Patients are able to understand and sign informed consent Patients are able to understand and complete study questionnaires Patients are prepared to discontinue all pain medications including non-steroidal anti-inflammatory drugs (NSAIDs), and medications for sleep or mood disturbances two weeks prior to beginning the study. Acetaminophen, up to 2 extra-strength, three times daily, will be allowed for break-through pain. Medication use will be surveyed at each visit (See Appendix). Age - > 18 Females with no documented evidence of current pregnancy, and willingness to take the necessary precautions to prevent pregnancy for the duration of the study period Exclusion Criteria: • Patients with a significant musculoskeletal or rheumatic disorder that may confuse the diagnosis Any subject with suicidal thoughts in the past or currently Patient with a history of renal disease, heart disease, bleeding problems or low platelet counts Women who are breast feeding Men or women who plan to have children during the course of the study Unable to discontinue any medications prescribed for pain, other than acetaminophen, or any medications for sleep or mood disturbances for at least 2 weeks before the study Unable to discontinue any mediations used for sleep disturbances Patients currently being treated for any psychiatric illness including depression or anxiety disorder Patients currently taking antidepressant, anti-anxiety, or antipsychotic medications. Inability to understand and sign informed consent and complete questionnaires.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br> | Drug: Pregabalin<br>* Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg<br>* Other names: Lyrica;|
| Placebo Comparator: Placebo<br> | Drug: Pregabalin<br>* Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain VAS from study entry to end of study |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total score FIQ from study entry to last visit. |  | 12 weeks | 
| Change in total score FM 2010 Clinical Scale from study entry to last visit. |  | 12 Weeks | 
| Change in PGIC from study entry to last visit. |  | 12 weeks | 
| Change in total score for HRQOL from study entry to last visit. |  | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, pregabalin, Lyrica