NCT01800097

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

2.4 years

First QC Date

October 23, 2012

Last Update Submit

June 23, 2015

Conditions

StrokePost Stroke Fatigue

Keywords

strokefatiguemodafinil

Outcome Measures

Primary Outcomes (1)

  • Multidimensional Fatigue Inventory (MFI- 20)

    Questionnaire

    3 months

Secondary Outcomes (5)

  • MFI-20

    1 month

  • MFI-20

    6 months

  • Fatigue severity scale (FSS)

    3 months

  • FSS

    1 month

  • FSS

    6 months

Other Outcomes (23)

  • Change in bone mineral density and musclemass from baseline to 3 months

    3 months

  • Reactiontime

    1 month

  • Stroke Specific Quality Of Life (SSQOL)

    3 months

  • +20 more other outcomes

Study Arms (2)

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Modafinil

ACTIVE COMPARATOR

Modafinil

Drug: modafinil

Interventions

modafinilDRUG

Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months

Also known as: modiodal, provigil
Modafinil
placeboDRUG

Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Herlev Hospital,

Herlev, 2730, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26534969DERIVED

MeSH Terms

Conditions

StrokeFatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Karsten Overgaard, MD

    Department of Neurology, Herlev Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2012

First Posted

February 27, 2013

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

DK(1)