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NCT03735901Active, not recruitingPhase 3

Enhancement of Stroke Rehabilitation With Levodopa

Enhancement of Stroke Rehabilitation With Levodopa (ESTREL): a Randomized Placebo-controlled Trial

Source: ClinicalTrials.gov · Last updated 15 Oct 2024

Brief summary (registry, in English)

Trial investigates the benefits and harms of Levodopa /Carbidopa 100/25mg compared to placebo (given in addition to standardized rehabilitation based on the principles of motor learning) and whether there is an association with a patient-relevant enhancement of functional recovery in acute stroke patients. Study participants will be randomized 1:1.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
610 (actual)
First submitted
7 Nov 2018
Start date
14 Jun 2019
Primary completion date
27 Aug 2024
Lead sponsor
University Hospital, Basel, Switzerland
Diseases
Stroke
NCT number
NCT03735901

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 610
  • From 14 Jun 2019 to the primary completion date, 27 Aug 2024
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Inability or unwillingness to comply with study procedures including adherence to study drug intake (orally, or via nasogastric tube or percutaneous endoscopic gastrostomy tube)
  • Previously dependent in the basal activities of daily living (defined as modified Ranking Scale prior to stroke \> 3)

Other illness

  • Diagnosis of Parkinson's Disease
  • Known hypersensitivity to Levodopa/Carbidopa and other contraindications for Levodopa/Carbidopa as outlined in the summary of product characteristics

Age

  • Women who are pregnant or breast feeding, or who intend to become pregnant during the course of the study. Women of childbearing age must take a pregnancy test to be eligible for the study.

Other

  • Use of Levodopa mandatory according to judgement of treating physician
  • Severe aphasia (i.e. unable to follow two-stage-commands)
  • Pre-existing hemiparesis
  • Lack of safe contraception, defined as: Female Participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. Female Participants who are surgically sterilized / hysterectomized or post- menopausal for longer than 2 years are not considered as being of child- bearing potential.

Who the study is looking for

  • Acute ischemic or hemorrhagic (i.e. intracerebral hemorrhage excluding subarachnoid hemorrhage and cerebral venous sinus thrombosis) stroke ≤ 7 days prior to randomization
  • Clinically meaningful hemiparesis (i.e. scoring a total of ≥ 3 points on the following NIH stroke scale score items (i) motor arm, (ii) motor leg, (iii) limb ataxia; a distal arm paresis is equivalent to one of the aforementioned (i-iii))
  • Time of randomization ≥24-hours since thrombolysis or thrombectomy
  • In-hospital rehabilitation required
  • Capable to participate in standardized rehabilitation therapy
  • Informed consent of patient or next of kin

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kantonsspital Aarau, Neurozentrum
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AarauSwitzerlandUnknown status
Kantonsspital Baden
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BadenSwitzerlandUnknown status
RehaClinic AG
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Bad ZurzachSwitzerlandUnknown status
Felix Platter Spital
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BaselSwitzerlandUnknown status
Stroke-Center Universitätsspital Basel
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BaselSwitzerlandUnknown status
Inselspital Universitätsklinik für Neurologie
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BernSwitzerlandUnknown status
Kantonsspital Graubünden, Departement Innere Medizin / Neurologie
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ChurSwitzerlandUnknown status
HFR Fribourg Hopital Cantonal, U. de Neurologie
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FribourgSwitzerlandUnknown status
Centre hospitalier universitaire vaudois, Service de Neurologie
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LausanneSwitzerlandUnknown status
HFR Meyriez-Murten, Clinique de Réhabilitation
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MeyriezSwitzerlandUnknown status
Kantonsspital Münsterlingen
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MünsterlingenSwitzerlandUnknown status
Reha Rheinfelden
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RheinfeldenSwitzerlandUnknown status
Kantonsspital St.Gallen, Klinik für Neurologie
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Sankt GallenSwitzerlandUnknown status
Hôpital du Valais - Sion, Service de neurologie
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SionSwitzerlandUnknown status
Hôpital du Valais - Sion
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SionSwitzerlandUnknown status
Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation
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ValensSwitzerlandUnknown status
Cereneo Schweiz AG
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VitznauSwitzerlandUnknown status
Zürcher RehaZentrum Wald
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WaldSwitzerlandUnknown status
Rheinburg Klinik AG
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WalzenhausenSwitzerlandUnknown status
Kantonsspital Winterthur
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WinterthurSwitzerlandUnknown status
Rehaklinik Zihlschlacht
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ZihlschlachtSwitzerlandUnknown status
Klinik Lengg AG
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ZurichSwitzerlandUnknown status
Head Stroke Center Klinik Hirslanden
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ZurichSwitzerlandUnknown status
Universitätsspital Zürich, Klinik für Neurologie
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ZurichSwitzerlandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.