Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
REC 7197
Study information
Scientific title
Acronym
M & F
Study hypothesis
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
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
Patient information sheet
Condition
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
Overall study end date
01/12/2006
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
Both
Target number of participants
24
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
01/12/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Consultant Anaesthetist
Leicester
LE5 4PW
United Kingdom
Sponsor information
Organisation
University Hospitals of Leicester NHS Trust (UK)
Sponsor details
Director of Research
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Industry
Funder name
Cephalon UK Independent Research Programme grant (UK).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|