Treatment of Post Stroke Fatigue With a Wakefulness Promo... | NCT01800097

Studies
Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

NCT01800097

Sponsor

Herlev Hospital

Status

Terminated

Last Update Posted

Jun 24, 2015Estimated

Enrollment

41Actual

Phase

Phase 3

Conditions

Stroke
Post Stroke Fatigue

Interventions

modafinil
placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Feb 25, 2013

First Posted Date

Feb 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	placebo	Drug: placebo
Modafinil	Active Comparator	Modafinil	Drug: modafinil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
modafinil	Drug	Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months	Modafinil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Multidimensional Fatigue Inventory (MFI- 20)	Questionnaire	3 months

Secondary Outcomes

Measure	Description	Time Frame
MFI-20	Questionnaire	1 month
MFI-20	Questionnaire	6 months

Other Outcomes

Measure	Description	Time Frame
Change in bone mineral density and musclemass from baseline to 3 months	DXA-scans. (dual energy x-ray absorptiometry)	3 months
Reactiontime	A special designed computerprogramme will be used to measure the patients reactiontime.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karsten Overgaard, MD	Department of Neurology, Herlev Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, Herlev Hospital,		Herlev		2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26534969	Derived	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.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic