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TerminatedNCT00572767Updated Dec 13, 2007

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

A Phase 4 interventional study of Dextro-Amphetamin and Glucose in Stroke, sponsored by Reha Rheinfelden. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-12-13.

Sponsored by Reha Rheinfelden · Phase 4, Interventional, and Treatment

Why this study was terminated
Intended length of study ended
Phase
Phase 4
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).
02

Conditions studied

  • Stroke

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Keywords

  • randomised-controlled trial
  • ischemic stroke
  • motor recovery
  • amphetamine
  • motor recovery of patients after a first-ever ischemic stroke
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    1

    Drug: Dextro-Amphetamin

  • Placebo comparator
    2

    Other: Glucose

Interventions

  • DrugDextro-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.

  • OtherGlucose

    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.

05

What researchers measure

Primary outcomes

  1. Chedoke-McMaster Stroke Assessment (motor impairment measure)

    Time frame: Over the whole duration of the study (2001 to 2006, ten times for each patient)

06

Study locations

1 site
  • Reha Rheinfelden
    Rheinfelden, AG 4310, Switzerland
07

References and documents

Publications

  • 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. PubMed 21712481 ↗
08

Registry details

Key details

Study ID
NCT00572767
Lead sponsor
Reha Rheinfelden
First posted
Dec 13, 2007
Start date
Jan 2001
Completion
Sep 2006
Last update
Dec 13, 2007

Study contacts

Thierry M. Ettlin, Prof.
principal investigator · Reha Rheinfelden

Oversight

Data monitoring committee
No
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