Clinical trial NCT01800097: Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent
Official title: Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Stroke
Post Stroke Fatigue
Keywords: stroke
fatigue
modafinil
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2013-02-27
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI- 20)
timeFrame: 3 months
Secondary outcomes:
measure: MFI-20
timeFrame: 1 month
measure: MFI-20
timeFrame: 6 months
measure: Fatigue severity scale (FSS)
timeFrame: 3 months
measure: FSS
timeFrame: 1 month
measure: FSS
timeFrame: 6 months
Other outcomes:
measure: Change in bone mineral density and musclemass from baseline to 3 months
timeFrame: 3 months
measure: Reactiontime
timeFrame: 1 month
measure: Stroke Specific Quality Of Life (SSQOL)
timeFrame: 3 months
measure: Change in Barthel Index
timeFrame: 3 months
measure: Modified Ranking Scale
timeFrame: 3 months
measure: Multidimensional Depression Inventory
timeFrame: 3 months
measure: Change in "Time up and go" and "chair to stand test" from baseline
timeFrame: 3 months
measure: Cognitive performance, Montreal Cognitive Assessment(MOCA)
timeFrame: 3 months
measure: Change in bone mineral density and musclemass from baseline to 6 months
timeFrame: 6 months
measure: Reactiontime
timeFrame: 3 months
measure: Reactiontime
timeFrame: 6 months
measure: Stroke Specific Quality Of Life
timeFrame: 6 months
measure: Change in Barthel Index
timeFrame: 6 months
measure: Modified Ranking Scale
timeFrame: 6 months
measure: Change in "Time up and go" and "chair to stand test" from baseline
timeFrame: 6 months
measure: Multidimensional Depression Inventory
timeFrame: 6 months
measure: Cognitive performance, Montreal Cognitive Assessment(MOCA)
timeFrame: 6 months
measure: Stroke Specific Quality Of Life (SSQOL)
timeFrame: 1 month
measure: Change in Barthel Index
timeFrame: 1 month
measure: Modified Ranking Scale
timeFrame: 1 month
measure: Multidimensional Depression Inventory
timeFrame: 1 month
measure: Change in "Time up and go" and "chair to stand test" from baseline
timeFrame: 1 month
measure: Cognitive performance, Montreal Cognitive Assessment(MOCA)
timeFrame: 1 month
Locations:
city: Herlev
country: Denmark
facility: Department of Neurology, Herlev Hospital,
Study officials:
affiliation: Department of Neurology, Herlev Hospital
name: Karsten Overgaard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poulsen MB, Damgaard B, Zerahn B, Overgaard K, Rasmussen RS. Modafinil May Alleviate Poststroke Fatigue: A Randomized, Placebo-Controlled, Double-Blinded Trial. Stroke. 2015 Dec;46(12):3470-7. doi: 10.1161/STROKEAHA.115.010860. Epub 2015 Nov 3.