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

December 12, 2007
December 12, 2007
January 2001
Not Provided
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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).
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • 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.

  • Experimental: 1
    Intervention: Drug: Dextro-Amphetamin
  • Placebo Comparator: 2
    Intervention: Other: Glucose
Schuster C, Maunz G, Lutz K, Kischka U, Sturzenegger R, Ettlin T. Dexamphetamine improves upper extremity outcome during rehabilitation after stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Oct;25(8):749-55. doi: 10.1177/1545968311405674. Epub 2011 Jun 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
September 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00572767
2000/001, 2000/030
No
Ettlin, Th. Prof., Reha Rheinfelden
Reha Rheinfelden
Not Provided
Principal Investigator: Thierry M. Ettlin, Prof. Reha Rheinfelden
Reha Rheinfelden
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP