Gabapentin in Fibromyalgia Trial (GIFT)

This study will assess the safety and effectiveness of the drug gabapentin in reducing pain associated with primary fibromyalgia.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: gabapentin

Detailed Description

Fibromyalgia, a chronic musculoskeletal pain disorder of unknown etiology, is characterized by widespread musculoskeletal pain, fatigue, and multiple tender points; the disease affects 3 to 6 million Americans. A person is considered to have fibromyalgia if he or she has widespread pain in combination with tenderness in at least 11 of 18 specific tender point sites.

Treatment of fibromyalgia requires a comprehensive approach and includes aerobic exercise, heat and massage, antidepressant medications, and relaxation. Gabapentin, a medication used to treat seizures, has been shown to work on pain transmission pathways and may relieve the pain associated with fibromyalgia. This study will assess the efficacy of gabapentin in reducing pain severity in fibromyalgia as measured by the average pain item of the Brief Pain Inventory (BPI) score.

Patients will be randomized to receive gabapentin or placebo. The gabapentin dose will be titrated for persisting symptoms and as tolerated during the first 6 weeks of the study, reaching final doses between 1800 mg/day and 2400 mg/day. Patients will then continue on the final dose for the remaining 6 weeks of the study. Following completion of the 12 week treatment phase, patients will be tapered off of the medication over 1 week.

The effectiveness of gabapentin will be assessed using the BPI. The BPI is a self-administered questionnaire that measures the severity of pain and the interference of pain on function over the past 24 hours. Other assessments will include the total Fibromyalgia Impact Questionnaire (FIQ) score; six 11-point Likert-type scales in the FIQ that measure pain, fatigue, morning tiredness, stiffness, anxiety, and depression; the mean tender point pain threshold; Clinical Global Impression of Severity (CGI-Severity); Patient Global Impression of Improvement (PGI-Improvement); the Short-form McGill Pain Questionnaire (SF-MPQ); the Medical Outcomes Study Short Form-36 (SF-36); the Montgomery Asberg Depression Rating Scale (MADRS); and the Medical Outcomes Sleep Scale (MOS-Sleep).

• Study Type: Interventional
• Enrollment: 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital/Harvard Medical School (must live in the Boston, MA area)
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital (must live in the Boston, MA area)
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati College of Medicine, Department of Psychiatry (must live in the Cincinnati, OH area)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary fibromyalgia as defined by the American College of Rheumatology (ACR)
• Score greater than 4 on the average pain item of the BPI at screening
• Ability to understand and cooperate with study procedures
• Acceptable methods of contraception

Exclusion Criteria:

• Unwillingness or inability to provide written informed consent.
• Lifetime history of psychosis, hypomania or mania, epilepsy, or dementia
• History of seizures or status epilepticus
• DSM-IV diagnosis of alcohol or substance dependence with the exception of nicotine dependence within 6 months prior to screening visit
• A positive urine drug screen for any substances of abuse or excluded medication. (NOTE: If the participant has a positive drug screen at Visit 1 for an excluded medication that may not have had an adequate wash-out period, a retest may be performed prior to Visit 2. If the retest is positive, the participant will be excluded.)
• Serious suicide risk
• Treatment refractory in the opinion of study official
• Pregnant or breastfeeding
• Clinically unstable medical or psychiatric condition that could interfere with the absorption, metabolism, excretion, or safety of gabapentin or interfere with the assessment of disease severity
• Thyroid-stimulating hormone (TSH) concentrations outside the range of 0.30-8.0 UlU/mL. (NOTE: Participants who have been on a stable dose of thyroid supplementation for at least the past 3 months, have medically appropriate TSH values, and are clinically euthyroid may participate in the study.)
• Any screening laboratory assay that is outside of the local laboratories' normal range by more than 20% or is deemed to be a clinically significant abnormality by the investigator, with the exception of liver function tests (AST, ALT, alkaline phosphatase) which must be within 1.5 X upper limit of normal
• Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis)
• History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
• An abnormal Westergren erythrocyte sedimentation rate (e.g., ESR > 40 mm/min)
• An abnormal antinuclear antibody (ANA > 1:160) or rheumatoid factor (RF >15 IU/ml)
• Treatment with a monoamine oxidase inhibitor, tricyclic, SSRI antidepressant (with the exception of fluoxetine), or lithium within 2 weeks prior to beginning study medication
• Treatment with fluoxetine within 30 days prior to beginning study medication
• Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within 1 week prior to beginning study medication
• Treatment with any other excluded medications that cannot be discontinued at the screening visit (see Table 2 for a list of excluded medications)
• Previous treatment with gabapentin
• Previous treatment with pregabalin
• Treatment with any other investigational medications within 30 days prior to screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Brief Pain Inventory (BPI) average pain item

Secondary Outcome Measures

Outcome Measure
Clinical Global Impression of Severity
Patient Global Impression of Improvement
Montgomery-Asberg Depression Rating Scale (MADRS)
McGill Pain Questionnaire
Fibromyalgia Impact Questionnaire
Mean Tender Point Pain Threshold
Medical Outcomes Study Short Form-36 (SF-36)
Medical Outcomes Sleep Scale (MOS-Sleep)
Fibromyalgia Rating Scale (FRS)

Collaborators and Investigators

• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Lesley M. Arnold, MD, University of Cincinnati

Publications and helpful links

Helpful Links

• Click here for more information about the Women's Health Research Program.

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: March 28, 2003
• First Submitted That Met QC Criteria: March 28, 2003
• First Posted (Estimate): March 31, 2003

Study Record Updates

• Last Update Posted (Estimate): December 19, 2007
• Last Update Submitted That Met QC Criteria: December 14, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Keywords: Gabapentin
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: N01 AR22264; NIAMS-089