Status:
TERMINATED
Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent
Lead Sponsor:
Herlev Hospital
Conditions:
Stroke
Post Stroke Fatigue
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is an investigator initiated placebo controlled double blinded trial. The hypothesis is that treatment with modafinil positively will affect behavioural and cognitive rehabilitation after s...
Eligibility Criteria
Inclusion
- 18 years of age and stroke within 14 days
- Modified Rankin Scale 3 or under and Barthel 85 or over before stroke
- Person that can understand instruction and do tests and questionnaires on their own or with support
- has given informed consent
- MFI-20 score of 12 or more
- Infertile person or fertile women tested negative of pregnancy and using safe anticonception
Exclusion
- Dementia or other neuropsychiatric disease making the person incapable of understanding instructions
- Other disease with fatigue as a known symptom
- stroke induced by trauma, infection or surgical procedure
- former drug abuse
- known contraindication to treatment with modafinil
- known active malignancy, benign intracranial tumor, subdural or epidural bleeding
- kidneydysfunction with creatinin more than 265 micromol/L or liver disease with ASAT (aspartate aminotransferase) elevated to more than 70 U/L for women or 100 U/L for men.
- allergy to project treatment
- use of benzodiazepin or antiepileptic drugs in a fixed dose. Sleeping pills not included.
- Patients threaded with ciclosporin or anti HIV medication
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01800097
Start Date
October 1 2012
End Date
March 1 2015
Last Update
June 24 2015
Active Locations (1)
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1
Department of Neurology, Herlev Hospital,
Herlev, Denmark, 2730