A randomised, placebo-controlled, rising-dose crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia - Modafinil and fibromyalgia
- Conditions
- Fibromyalgia
- Registration Number
- EUCTR2005-002209-22-GB
- Lead Sponsor
- niversity Hospitals of Leicester NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Written Informed Consent
Widespread body pain
A positive tender point count of at least 11 out of 18 points on digital palpation
Daily fatigue of greater than 4 points on the Fatigue Scale
Fatigue for greater than 24 hours following minimal activity
Age 18 to 65 years inclusive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of inflammatory disease or neoplasm
Major psychological disorders known to affect sleep as assessed by the PRIME-MD scale.
Pregnancy
Breast feeding mothers
Hypertension
Patients with a score of less than 24 out of 30 on the Mini-Mental State Exam.
Any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
Arrhythmia
History of left ventricular hypertrophy, cor pulmonale or mitral valve prolapse
Lactose intolerance
Known sensitivity to other constituents of modafinil tablet ie maize starch, magnesium silicate, croscarmellose sodium, Povidone K90, Talc or magnesium stearate.
Patient is taking anticonvulsants, anticoagulants, melatonin, St John’s Wort, methylphenidate, amphetamines, pemoline, zolpidem, monoamine oxidase inhibitors, barbiturates, benzodiazepines, lithium or antipsychotic drugs.
Has a significant deviation from normal in the physical examination.
Has any disorder that may interfere with drug absorption, distribution, metabolism or excretion (including gastro-intestinal surgery).
Any other sleep disorder including obstructive sleep apnoea, narcolepsy or periodic leg movement syndrome.
Previous use of Modafinil (Provigil).
Clinical history of heart, kidney or liver disease, heart attack, diseases of the CNS, alcoholism or drug dependence.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method