Fibromyalgia Musculoskeletal Diseases Fibromyalgia
Conditions
Interventions
TRIAL TERMINATED 02 MARCH 2006 BEFORE ANY RECRUITMENT OF PATIENTS.
The modafinil group (Gp 2) will take one 100 mg modafinil tablet each morning on days 1-7, increasing to 200 mg on days 8-14 and 300
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Memory, attention and psychomotor speed 2. Daytime sleepiness as measured by the Epworth Sleepiness Scale 3. Subjective measures of sleep quality and disturbance 4. Sleep duration as measured by actigraphy 5. Subjective measures of sleep duration, as reported in sleep diaries 6. Subjective measures of physical vitality, psychological and social function as assessed by the short-form health survey, SF36 7. Pain, as measured by the Short-form McGill Pain Questionnaire (SF-MPQ) | — |
Countries
United Kingdom
Outcome results
None listed