The influence of modafinil on the post-exercise exacerbation of symptoms in patients with chronic fatigue syndrome

Phase 3

Recruiting

• Conditions: chronic fatigue syndrome; Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

• Registration Number: ACTRN12616000487415
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

i) meeting international diagnostic criteria for chronic fatigue syndrome (Fukuda, 1994)
ii) have their treating exercise physiologist and clinical psychologist resolve that they have a stable pattern of symptom severity, as well as having optimized and stable sleep patterns and well-managed mood disturbance
iii) undertaking regular of 10-20 minutes walking at a gentle pace without producing a post-exertional exacerbation of symptoms (that is an hour or more of worsened fatigue and other symptoms).

Exclusion Criteria

i) currently use beta-blockers or other agents known to affect heart rate response to exercise; or
ii) have any medical (e.g. lower limb injury) condition which may preclude reliable participation in exercise testing
iii) currently use central nervous system medications (e.g. Benzodiazepines and other sedative-hyponotics (e.g. stilnox), anti-epileptics, high-dose antidepressants (low-dose allowed),
iv) are pregnant or breastfeeding
v) have hepatic impairment
vi) are hypersensitive to modafinil
vii) have a history of left ventricular hypertrophy or ischaemic heart disease, or other clinically significant cardiac disease;
viii) uncontrolled anxiety disorder,
ix) have previously taken modafinil and experienced an adverse reaction.
x) taking anti-hypertensives/beta blockers
xi) taking corticosteroids
xii) taking major analgesics (e.g. oxycodone)

Study & Design

• Study Type: Interventional
• Study Design: Not specified