Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

NCT01896128

Stroke Cerebrovascular Accident Hemiparesis

COMPLETED PHASE2

Understanding Mental Fatigue After Stroke

NCT04866420

Stroke Post-Stroke Fatigue Fatigue

COMPLETED

Functional Characterisation of Post-stroke Fatigue

NCT04277234

Stroke Stroke Sequelae

UNKNOWN

Mechanisms of Neuromuscular Fatigue Post Stroke

NCT01688570

Stroke

COMPLETED EARLY_PHASE1

Effect of Lifestyle Changes on BDNF Level After Stroke

NCT03701815

Stroke

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Post Stroke Fatigue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Modafinil

Group Type ACTIVE_COMPARATOR

modafinil

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

modafinil

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

modiodal, provigil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No