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Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Primary Purpose

Stroke, Post Stroke Fatigue

Status
Terminated
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
modafinil
placebo
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, fatigue, modafinil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neurology, Herlev Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

Modafinil

Arm Description

placebo

Modafinil

Outcomes

Primary Outcome Measures

Multidimensional Fatigue Inventory (MFI- 20)
Questionnaire

Secondary Outcome Measures

MFI-20
Questionnaire
MFI-20
Questionnaire
Fatigue severity scale (FSS)
FSS
Questionnaire
FSS
Questionnaire

Full Information

First Posted
October 23, 2012
Last Updated
June 23, 2015
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01800097
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Post Stroke Fatigue
Keywords
stroke, fatigue, modafinil

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Modafinil
Arm Type
Active Comparator
Arm Description
Modafinil
Intervention Type
Drug
Intervention Name(s)
modafinil
Other Intervention Name(s)
modiodal, provigil
Intervention Description
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Primary Outcome Measure Information:
Title
Multidimensional Fatigue Inventory (MFI- 20)
Description
Questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
MFI-20
Description
Questionnaire
Time Frame
1 month
Title
MFI-20
Description
Questionnaire
Time Frame
6 months
Title
Fatigue severity scale (FSS)
Time Frame
3 months
Title
FSS
Description
Questionnaire
Time Frame
1 month
Title
FSS
Description
Questionnaire
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Change in bone mineral density and musclemass from baseline to 3 months
Description
DXA-scans. (dual energy x-ray absorptiometry)
Time Frame
3 months
Title
Reactiontime
Description
A special designed computerprogramme will be used to measure the patients reactiontime.
Time Frame
1 month
Title
Stroke Specific Quality Of Life (SSQOL)
Description
Questionnaire
Time Frame
3 months
Title
Change in Barthel Index
Description
score
Time Frame
3 months
Title
Modified Ranking Scale
Description
score
Time Frame
3 months
Title
Multidimensional Depression Inventory
Description
Questionnaire
Time Frame
3 months
Title
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame
3 months
Title
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Description
test
Time Frame
3 months
Title
Change in bone mineral density and musclemass from baseline to 6 months
Description
DXA-scan
Time Frame
6 months
Title
Reactiontime
Description
A special designed computerprogramme will be used to measure the patients reactiontime.
Time Frame
3 months
Title
Reactiontime
Description
A special designed computerprogramme will be used to measure the patients reactiontime.
Time Frame
6 months
Title
Stroke Specific Quality Of Life
Description
Questionnaire
Time Frame
6 months
Title
Change in Barthel Index
Time Frame
6 months
Title
Modified Ranking Scale
Description
score
Time Frame
6 months
Title
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame
6 months
Title
Multidimensional Depression Inventory
Description
Questionnaire
Time Frame
6 months
Title
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Description
test
Time Frame
6 months
Title
Stroke Specific Quality Of Life (SSQOL)
Description
Questionnaire
Time Frame
1 month
Title
Change in Barthel Index
Description
score
Time Frame
1 month
Title
Modified Ranking Scale
Description
score
Time Frame
1 month
Title
Multidimensional Depression Inventory
Description
Questionnaire
Time Frame
1 month
Title
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame
1 month
Title
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Description
test
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Overgaard, MD
Organizational Affiliation
Department of Neurology, Herlev Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Herlev Hospital,
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26534969
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.
Results Reference
derived

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Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

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