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ISRCTN
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ISRCTN34021674
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ClinicalTrials.gov identifier
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Public title
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A randomised, placebo-controlled, rising dose, crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia
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Scientific title
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Acronym
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M & F
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Serial number at source
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REC 7197
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Study hypothesis
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That patients receiving modafinil will report less subjective fatigue, reduced sleepiness, improved physical health and vitality scores on the SF36 and will demonstrate improved psychomotor and cognitive skills, compared with those receiving placebo.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised placebo-controlled rising dose crossover study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Fibromyalgia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2005
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Anticipated end date
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01/12/2006
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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24
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Interventions
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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 mg on days 15-35. The placebo group (Gp 1) will take placebo tablets according to the same regime. After a one week washout period, Gp 1 will take modafinil and Gp 2, placebo, repeating the rising-dose schedule.
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Primary outcome measure(s)
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To determine whether modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory.
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Secondary outcome measure(s)
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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)
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Sources of funding
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Cephalon UK Independent Research Programme grant (UK).
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Trial website
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Publications
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Contact name
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Dr
Christopher
Hanning
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Address
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Consultant Anaesthetist
Leicester General Hospital
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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Director of Research
Leicester General Hospital
Gwendolen Road
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City/town
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Leicester
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Zip/Postcode
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LE5 4PW
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Country
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United Kingdom
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Date applied
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04/08/2005
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Last edited
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18/03/2010
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Date ISRCTN assigned
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10/10/2005
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