Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

This study has been terminated.

(Intended length of study ended)

Sponsor:

Information provided by:

Reha Rheinfelden

ClinicalTrials.gov Identifier:

NCT00572767

First received: December 12, 2007

Last updated: NA

Last verified: December 2007

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

December 12, 2007

Start Date ^ICMJE

January 2001

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Chedoke-McMaster Stroke Assessment (motor impairment measure) [ Time Frame: Over the whole duration of the study (2001 to 2006, ten times for each patient) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke

Official Title ^ICMJE

Evaluation of the Therapeutic Effect of Amphetamine in Association to Physiotherapy on Motor Recovery After Stroke: a Randomised, Double-Blinded, Placebo-Controlled Trial

Brief Summary

The aim of the study is to evaluate the effect of Dextro-amphetamin added to physiotherapy on motor recovery in patients after stroke. The study is a double-blinded placebo-controlled randomised controlled trial.

Patients after a first-ever ischemic stroke will receive Dexamphetamine (10mg) twice per week for a duration of five weeks after a baseline phase of two weeks.

The outcome measure focuses on motor recovery and will be assessed:

one and two weeks before study intervention (baseline phase)
five times during the study intervention
one week after study intervention (follow-up)
once after six and twelve months after start of the study intervention (follow-up).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Drug: Dextro-Amphetamin
After a two week baseline phase the patients will receive a dose of 10mg Dexamphetamine on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.
Other: Glucose
After a two week baseline phase the patients will receive a dose of 10mg of a placebo (same appearance as the experimental drug) on two days per week for five weeks. Within a time frame of one to three hours they should receive physiotherapy focusing on neurodevelopmental (NDT) for one hour.

The treatment of the control group will be the same as for the experimental group except the content of the drug capsule.

Study Arm (s)

Experimental: 1
Intervention: Drug: Dextro-Amphetamin
Placebo Comparator: 2
Intervention: Other: Glucose

Publications *

Schuster C, Maunz G, Lutz K, Kischka U, Sturzenegger R, Ettlin T. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. Epub 2011 Jun 28.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

September 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients after first-ever ischemic stroke with a clinical relevant paresis of the upper and lower limb (general clinical muscle testing below level four)
correlation of clinical symptoms with a brain imaging (CT or MRI)
able to communicate with the neurological examiner and understand the aim/matter of the study (with or without aphasia)
start of the first oral application of the study drug between the fourteenth and 60th day after stroke onset
older than 13 years
given written informed consent (or two independent witnesses)

Exclusion Criteria:

intracranial or (chronic) subdural hemorrhages
any additional neurological or psychiatric illnesses
instable arrythmia
not controlled or treated arterial hypertension
ensured cardioembolic event
anxiolytica, neuroleptica, or alpha-adrenergic antagonists or agonists respectively
certain anticonvulsiva or antihypertonica
manifest hyperthyreosis
dementia or terminal illnesses
epilepsy, phaeochromocytoma or glaucoma
women known to be pregnant or lactating

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00572767

Other Study ID Numbers ^ICMJE

2000/001, 2000/030

Has Data Monitoring Committee

Responsible Party

Ettlin, Th. Prof., Reha Rheinfelden

Study Sponsor ^ICMJE

Reha Rheinfelden

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Thierry M. Ettlin, Prof.

Reha Rheinfelden

Information Provided By

Reha Rheinfelden

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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