Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Stroke Clinical Trial

Official title:

Treatment of Post Stroke Fatigue With Modafinil, Effect on Rehabilitation, Fatigue and Bonemass Index

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01800097
• Other study ID #: ModaA001
• Status: Terminated
• Phase: Phase 3
• First received: October 23, 2012
• Last updated: June 23, 2015
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue
• Post Stroke Fatigue
• Stroke

Intervention

Drug:
• modafinil
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
• placebo
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.

Locations

Country	Name	City	State
Denmark	Department of Neurology, Herlev Hospital,	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in bone mineral density and musclemass from baseline to 3 months	DXA-scans. (dual energy x-ray absorptiometry)	3 months	No
Other	Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	1 month	No
Other	Stroke Specific Quality Of Life (SSQOL)	Questionnaire	3 months	No
Other	Change in Barthel Index	score	3 months	No
Other	Modified Ranking Scale	score	3 months	No
Other	Multidimensional Depression Inventory	Questionnaire	3 months	No
Other	Change in "Time up and go" and "chair to stand test" from baseline		3 months	No
Other	Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	3 months	No
Other	Change in bone mineral density and musclemass from baseline to 6 months	DXA-scan	6 months	No
Other	Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	3 months	No
Other	Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.	6 months	No
Other	Stroke Specific Quality Of Life	Questionnaire	6 months	No
Other	Change in Barthel Index		6 months	No
Other	Modified Ranking Scale	score	6 months	No
Other	Change in "Time up and go" and "chair to stand test" from baseline		6 months	No
Other	Multidimensional Depression Inventory	Questionnaire	6 months	No
Other	Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	6 months	No
Other	Stroke Specific Quality Of Life (SSQOL)	Questionnaire	1 month	No
Other	Change in Barthel Index	score	1 month	No
Other	Modified Ranking Scale	score	1 month	No
Other	Multidimensional Depression Inventory	Questionnaire	1 month	No
Other	Change in "Time up and go" and "chair to stand test" from baseline		1 month	No
Other	Cognitive performance, Montreal Cognitive Assessment(MOCA)	test	1 month	No
Primary	Multidimensional Fatigue Inventory (MFI- 20)	Questionnaire	3 months	No
Secondary	MFI-20	Questionnaire	1 month	No
Secondary	MFI-20	Questionnaire	6 months	No
Secondary	Fatigue severity scale (FSS)		3 months	No
Secondary	FSS	Questionnaire	1 month	No
Secondary	FSS	Questionnaire	6 months	No