Stroke | Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent
Stroke research study
What is the primary objective of this study?
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 stroke, causing the treatment group to experience decreased fatigue, increased endurance, improved skills of sustaining attention and faster reaction times. The cognitive rehabilitation will show in increased muscle mass, decreased osteoporosis and better physical performances due to a higher level of physical activity.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Post Stroke Fatigue
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:modafinilTablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
Drug:placeboTablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2012
Completed Date: March 2015
Phase: Phase 3
Primary Outcome: Multidimensional Fatigue Inventory (MFI- 20)
Secondary Outcome: MFI-20
Study sponsors, principal investigator, and references
Principal Investigator: Karsten Overgaard, MD
Lead Sponsor: Herlev Hospital