Condition category
Musculoskeletal Diseases
Date applied
04/08/2005
Date assigned
10/10/2005
Last edited
18/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christopher Hanning

ORCID ID

Contact details

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

Additional identifiers

EudraCT 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

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

Trial setting

Not specified

Trial 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

Phase

Not Applicable

Drug names

Modafinil

Primary outcome measures

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 trial start date

01/09/2005

Overall trial end date

01/12/2006

Reason abandoned

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

Patient

Age group

Adult

Gender

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 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

Recruitment start date

01/09/2005

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial 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
United Kingdom

Sponsor type

Government

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes