StrokePhase 4NCT00572767
Evaluation of the Effect of Dextro-Amphetamin Added to Physiotherapy in Patients After Stroke
A Phase 4 study testing Dextro-Amphetamin and Glucose in people with Stroke, run by Reha Rheinfelden at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Dextro-Amphetamin and Glucose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2001to Sep 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- certain anticonvulsiva or antihypertonica
- manifest hyperthyreosis
- dementia or terminal illnesses
- epilepsy, phaeochromocytoma or glaucoma
- women known to be pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Stroke
- Being tested
- Dextro-Amphetamin, Glucose
- Keywords
- randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextro-AmphetaminDrug
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.
GlucoseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Dextro-Amphetamin |
| 2 | Placebo comparator | Not described Receives: Other: Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chedoke-McMaster Stroke Assessment (motor impairment measure)
Measured: Over the whole duration of the study (2001 to 2006, ten times for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startJan 2001
- Study completionSep 2006
Why it stopped: Intended length of study ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reha Rheinfelden
- Sponsor type
- University, hospital or other
- Investigators
- Thierry M. Ettlin, Prof., Principal investigator, Reha Rheinfelden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572767
- Sponsor's protocol ID
- 2000/001
- Other IDs
- 2000/030
- Status last verified
- Dec 2007
- First submitted
- 12 Dec 2007
- Last updated
- 13 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00572767
- Acronym / sponsor ID
- 2000/001
- Conditions
- Stroke
- Keywords
- randomised-controlled trial, ischemic stroke, motor recovery, amphetamine, motor recovery of patients after a first-ever ischemic stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Intended length of study ended
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Reha RheinfeldenUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Sep 2006 (actual)
- First posted
- 13 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dextro-Amphetamin |
| 2 | Placebo comparator | Other: Glucose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- intracranial or (chronic) subdural hemorrhages
- any additional neurological or psychiatric illnesses
- instable arrythmia
- not controlled or treated arterial hypertension
- ensured cardioembolic event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextro-AmphetaminAfter 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. | Drug | 1 |
| GlucoseAfter 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. | Other | 2 |
Primary outcome
Chedoke-McMaster Stroke Assessment (motor impairment measure)
Time frame: Over the whole duration of the study (2001 to 2006, ten times for each patient)
Results and safety
The study was stopped early (reason given: Intended length of study ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2007.
- Derived from this study: PubMed 21712481Schuster 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.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry M. Ettlin, Prof. principal investigator
Reha Rheinfelden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextro-Amphetamin and Glucose in people with Stroke, run by Reha Rheinfelden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Intended length of study ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chedoke-McMaster Stroke Assessment (motor impairment measure) (time frame: Over the whole duration of the study (2001 to 2006, ten times for each patient)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00572767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2007.