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Enhancement of Stroke Rehabilitation With Levodopa
Sponsor: University Hospital, Basel, Switzerland
Summary
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.
Official title: Enhancement of Stroke Rehabilitation With Levodopa (ESTREL): a Randomized Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
610
Start Date
2019-06-14
Completion Date
2029-06-30
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
IMP Levodopa 100mg/Carbidopa 25mg
Study treatment will comprise 3 phases: 1. Dose escalation phase: On day 1-3, patients will receive IMP solely in the morning; on day 4-6 in the morning and at lunch time; 2. full study treatment phase: from day 7 to day 34, 3 times per day (tid). 3. Treatment will stop with a tapering phase: On day 35-37, patients will receive IMP in the morning and at lunch time; on day 38 and 39 solely in the morning.
Matching placebo
Study treatment will comprise 3 phases: 1. Dose escalation phase: On day 1-3, patients will receive Placebo solely in the morning; on day 4-6 in the morning and at lunch time; 2. full study treatment phase: from day 7 to day 34, Placebo capsules 3 times per day (tid). 3. Treatment will stop with a tapering phase: On day 35-37, patients will receive Placebo in the morning and at lunch time; on day 38 and 39 solely in the morning.
Locations (24)
Kantonsspital Aarau, Neurozentrum
Aarau, Switzerland
RehaClinic AG
Bad Zurzach, Switzerland
Kantonsspital Baden
Baden, Switzerland
Felix Platter Spital
Basel, Switzerland
Stroke-Center Universitätsspital Basel
Basel, Switzerland
Inselspital, Universitätsklinik für Neurologie
Bern, Switzerland
Kantonsspital Graubünden, Departement Innere Medizin / Neurologie
Chur, Switzerland
HFR Fribourg Hopital Cantonal, U. de Neurologie
Fribourg, Switzerland
Centre hospitalier universitaire vaudois, Service de Neurologie
Lausanne, Switzerland
HFR Meyriez-Murten, Clinique de Réhabilitation
Meyriez, Switzerland
Kantonsspital Münsterlingen
Münsterlingen, Switzerland
Reha Rheinfelden
Rheinfelden, Switzerland
Kantonsspital St.Gallen, Klinik für Neurologie
Sankt Gallen, Switzerland
Hôpital du Valais - Sion, Service de neurologie
Sion, Switzerland
Hôpital du Valais - Sion
Sion, Switzerland
Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation
Valens, Switzerland
Cereneo Schweiz AG
Vitznau, Switzerland
Zürcher RehaZentrum Wald
Wald, Switzerland
Rheinburg Klinik AG
Walzenhausen, Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland
Rehaklinik Zihlschlacht
Zihlschlacht, Switzerland
Klinik Lengg AG
Zurich, Switzerland
Head Stroke Center Klinik Hirslanden
Zurich, Switzerland
Universitätsspital Zürich, Klinik für Neurologie
Zurich, Switzerland