Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia

Osteoporosis Medical Center, Beverly Hills, CA174 enrolled

Overview

A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

174

Conditions

Fibromyalgia

Interventions

Pregabalin

Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid. Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of fibromyalgia by ACR criteria * ambulatory patients * complete of 5 pain diaries during 1 week evaluation * other inclusion criteria may apply Exclusion Criteria: * pregnant or of childbearing potential not using contraceptives * use of pregabalin in the past * concomitant use of opioids or gabapentin * estimated creatinine clearance less than 60 * other criteria may apply

Locations (5)

David Silver MD Inc

Beverly Hills, California, United States

Stuart L Silverman MD Inc.

Beverly Hills, California, United States

Talbert Medical Group

Huntington Beach, California, United States

Catalina Pointe Clinial Research

Tucson, California, United States

Affilaites in Medical Specialty

West Hills, California, United States

Outcomes

Primary Outcomes

Pain score evaluation by NRS

Least square mean change in Fibromyalgia pain at 8weeks compared to baseline utilizing an 11 point numerical rating scale daily pain diary (0 = no pain to 10 =worst possible pain) performed at daily awakening.

Time frame: 8 weeks

Secondary Outcomes

Patient Global Impression of Change

Time frame: At weeks 4 and 8

Discontinuation rate

Discontinuation rates due to lack of efficacy and discontinuation rates due to adverse event.

Time frame: 9 weeks

Improvements in Wolfe Symptom Severity Score

Wolfe Symptom Severity scales for pain, fatigue, trouble sleeping, trouble with anxiety or depression, trouble thinking or remembering, overall FM severity, problems awaking feeling unrefreshed

Time frame: 9 weeks