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

Information source: Reha Rheinfelden
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stroke

Intervention: Dextro-Amphetamin (Drug); Glucose (Other)

Phase: Phase 4

Status: Terminated

Sponsored by: Reha Rheinfelden

Official(s) and/or principal investigator(s):
Thierry M. Ettlin, Prof., Principal Investigator, Affiliation: Reha Rheinfelden


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).

Clinical Details

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

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

Primary outcome: Chedoke-McMaster Stroke Assessment (motor impairment measure)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Reha Rheinfelden, Rheinfelden, AG 4310, Switzerland
Additional Information

Starting date: January 2001
Last updated: December 12, 2007

Page last updated: August 20, 2015

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