Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

June 23, 2015 updated by: Karsten Overgaard, Herlev Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Herlev, Denmark, 2730
        • Department of Neurology, Herlev Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Drug: placebo
Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
Active Comparator: Modafinil
Drug: modafinil
Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
Other Names:
  • modiodal, provigil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Multidimensional Fatigue Inventory (MFI- 20)
Time Frame: 3 months
Questionnaire
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MFI-20
Time Frame: 1 month
Questionnaire
1 month
MFI-20
Time Frame: 6 months
Questionnaire
6 months
Fatigue severity scale (FSS)
Time Frame: 3 months
3 months
FSS
Time Frame: 1 month
Questionnaire
1 month
FSS
Time Frame: 6 months
Questionnaire
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in bone mineral density and musclemass from baseline to 3 months
Time Frame: 3 months
DXA-scans. (dual energy x-ray absorptiometry)
3 months
Reactiontime
Time Frame: 1 month
A special designed computerprogramme will be used to measure the patients reactiontime.
1 month
Stroke Specific Quality Of Life (SSQOL)
Time Frame: 3 months
Questionnaire
3 months
Change in Barthel Index
Time Frame: 3 months
score
3 months
Modified Ranking Scale
Time Frame: 3 months
score
3 months
Multidimensional Depression Inventory
Time Frame: 3 months
Questionnaire
3 months
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame: 3 months
3 months
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Time Frame: 3 months
test
3 months
Change in bone mineral density and musclemass from baseline to 6 months
Time Frame: 6 months
DXA-scan
6 months
Reactiontime
Time Frame: 3 months
A special designed computerprogramme will be used to measure the patients reactiontime.
3 months
Reactiontime
Time Frame: 6 months
A special designed computerprogramme will be used to measure the patients reactiontime.
6 months
Stroke Specific Quality Of Life
Time Frame: 6 months
Questionnaire
6 months
Change in Barthel Index
Time Frame: 6 months
6 months
Modified Ranking Scale
Time Frame: 6 months
score
6 months
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame: 6 months
6 months
Multidimensional Depression Inventory
Time Frame: 6 months
Questionnaire
6 months
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Time Frame: 6 months
test
6 months
Stroke Specific Quality Of Life (SSQOL)
Time Frame: 1 month
Questionnaire
1 month
Change in Barthel Index
Time Frame: 1 month
score
1 month
Modified Ranking Scale
Time Frame: 1 month
score
1 month
Multidimensional Depression Inventory
Time Frame: 1 month
Questionnaire
1 month
Change in "Time up and go" and "chair to stand test" from baseline
Time Frame: 1 month
1 month
Cognitive performance, Montreal Cognitive Assessment(MOCA)
Time Frame: 1 month
test
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ModaA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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