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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
  Purpose

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).

Condition Intervention Phase
Stroke
 Drug: Dextro-Amphetamin
Other: Glucose
 Phase 4

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

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Further study details as provided by Reha Rheinfelden:

Primary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: January 2001
Study Completion Date: September 2006
Arms Assigned Interventions
Experimental: 1 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.
Placebo Comparator: 2 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572767

Locations
Switzerland
Reha Rheinfelden
Rheinfelden, AG, Switzerland, 4310
Sponsors and Collaborators
Reha Rheinfelden
Investigators
Principal Investigator: Thierry M. Ettlin, Prof. Reha Rheinfelden
  More Information

No publications provided by Reha Rheinfelden

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ettlin, Th. Prof., Reha Rheinfelden
ClinicalTrials.gov Identifier: NCT00572767     History of Changes
Other Study ID Numbers: 2000/001, 2000/030
Study First Received: December 12, 2007
Last Updated: December 12, 2007
Health Authority: Switzerland: Department of Health Aargau

Keywords provided by Reha Rheinfelden:
randomised-controlled trial
ischemic stroke
motor recovery
amphetamine
motor recovery of patients after a first-ever ischemic stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Amphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013