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ACTIVE NOT RECRUITING
NCT03735901
PHASE3

Enhancement of Stroke Rehabilitation With Levodopa

Sponsor: University Hospital, Basel, Switzerland

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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