A randomised, placebo-controlled, rising dose, crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia
| ISRCTN | ISRCTN34021674 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34021674 |
| Secondary identifying numbers | REC 7197 |
- Submission date
- 04/08/2005
- Registration date
- 10/10/2005
- Last edited
- 18/03/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Christopher Hanning
Scientific
Scientific
Consultant Anaesthetist
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom
Study information
| Study design | Randomised placebo-controlled rising dose crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | M & F |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure | To determine whether modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/09/2005 |
| Completion date | 01/12/2006 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 clinicians 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Anaesthetist
Leicester
LE5 4PW
United Kingdom
LE5 4PW
United Kingdom
Sponsor information
University Hospitals of Leicester NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Director of Research
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
"ROR" |
https://ror.org/02fha3693 |
|---|
Funders
Funder type
Industry
Cephalon UK Independent Research Programme grant (UK).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
