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

Phase 4

Terminated

• Conditions: Stroke
• Interventions: Drug: Dextro-Amphetamin; Other: Glucose

• Registration Number: NCT00572767
• Lead Sponsor: Reha Rheinfelden

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 available

Study Timeline

• Study Start: 2001-01
• Study Completion: 2006-09
• Status Verified: 2007-12
• Study First Submitted: 2007-12-12
• Study First Submitted QC: 2007-12-12
• Last Update Submitted: 2007-12-12
• Study First Posted: 2007-12-13
• Last Update Posted: 2007-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Dextro-Amphetamin	-
2	Glucose	-

Primary Outcome Measures

Name	Time	Method
Chedoke-McMaster Stroke Assessment (motor impairment measure)	Over the whole duration of the study (2001 to 2006, ten times for each patient)

Trial Locations

Locations (1)

Reha Rheinfelden; 🇨🇭 Rheinfelden, AG, Switzerland