A randomised, placebo-controlled, rising dose, crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia

Completed

• Conditions: Fibromyalgia; Musculoskeletal Diseases

• Registration Number: ISRCTN34021674
• Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Aged between 18 and 65 years inclusive, male or female of any ethnic origin and fluent in English
2. Widespread body pain - defined as pain on both sides of the body, and above and below the waist. Pain must be present in the axial skeleton, or anterior chest or thoracic spine or low back.
3. A positive tender point count defined as at least 11 out of 18 tender points on digital palpation of approximately 4 kg
4. Daily fatigue of greater than 4 points as assessed by the 14-item Fatigue Scale
5. Patient reports fatigue for >24 hours after minimal activity
6. Patient is willing and able to participate in computer-based testing and to maintain a sleep diary for the duration of the study
7. Written, informed consent

Exclusion Criteria

1. Major psychological disorders known to affect sleep, as assessed by the ?Primary Care Evaluation of Mental Disorders'
2. Any other sleep disorder including obstructive sleep apnoea, narcolepsy or periodic leg movement syndrome
3. A history of inflammatory disease or neoplasm
4. Pregnancy or lactation
5. Hypertension at a level that in the clinician?s opinion precludes the patient from participation in the study
6. A score of =23 on the Mini-Mental State Exam

7. Previous use of modafinil
8. A clinical history of heart, kidney or liver disease, heart attack, diseases of the central nervous system (CNS), alcoholism or drug dependence
9. Use of benzodiazepines, lithium or antipsychotic drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified