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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00572767
• Other study ID #: 2000/001
• Secondary ID: 2000/030
• Status: Terminated
• Phase: Phase 4
• First received: December 12, 2007
• Last updated: December 12, 2007
• Start date: January 2001
• Est. completion date: September 2006

Study information

• Verified date: December 2007
• Source: Reha Rheinfelden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Department of Health Aargau
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Reha Rheinfelden	Rheinfelden	AG

Sponsors (1)

Lead Sponsor	Collaborator
Reha Rheinfelden

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chedoke-McMaster Stroke Assessment (motor impairment measure)		Over the whole duration of the study (2001 to 2006, ten times for each patient)	No