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
Protocol serial number	REC 7197
Sponsor	University Hospitals of Leicester NHS Trust (UK)
Funder	Cephalon UK Independent Research Programme grant (UK).

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

Consultant Anaesthetist
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised placebo-controlled rising dose crossover study
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Modafinil
Primary outcome measure(s)	To determine whether modafinil is more effective than placebo in reducing subjective fatigue as measured by the Brief Fatigue Inventory.
Key secondary outcome measure(s)	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)
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	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Consultant Anaesthetist

Leicester
LE5 4PW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan