Trial | NCT00572767  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    16
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).
Study Started
Jan 31
2001
Study Completion
Sep 30
2006
Last Update
Dec 13
2007
Estimate

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.

1 Experimental

2 Placebo Comparator

Criteria 

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
No Results Posted