Phase
Condition
Stroke
Cerebral Ischemia
Treatment
IMP Levodopa 100mg/Carbidopa 25mg
Matching placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Acute ischemic or hemorrhagic (i.e. intracerebral hemorrhage excluding subarachnoidhemorrhage and cerebral venous sinus thrombosis) stroke ≤ 7 days prior torandomization
Clinically meaningful hemiparesis (i.e. scoring a total of ≥ 3 points on thefollowing NIH stroke scale score items (i) motor arm, (ii) motor leg, (iii) limbataxia; 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
Exclusion
Exclusion Criteria:
Diagnosis of Parkinson's Disease
Use of Levodopa mandatory according to judgement of treating physician
Inability or unwillingness to comply with study procedures including adherence tostudy drug intake (orally, or via nasogastric tube or percutaneous endoscopicgastrostomy tube)
Severe aphasia (i.e. unable to follow two-stage-commands)
Previously dependent in the basal activities of daily living (defined as modifiedRanking Scale prior to stroke > 3)
Pre-existing hemiparesis
Known hypersensitivity to Levodopa/Carbidopa and other contraindications forLevodopa/Carbidopa as outlined in the summary of product characteristics
Women who are pregnant or breast feeding, or who intend to become pregnant duringthe course of the study. Women of childbearing age must take a pregnancy test to beeligible for the study.
Lack of safe contraception, defined as: Female Participants of childbearingpotential, not using and not willing to continue using a medically reliable methodof contraception for the entire study duration, such as oral, injectable, orimplantable contraceptives, or intrauterine contraceptive devices, or who are notusing any other method considered sufficiently reliable by the Investigator inindividual cases. Female Participants who are surgically sterilized /hysterectomized or post- menopausal for longer than 2 years are not considered asbeing of child- bearing potential.
Study Design
Study Description
Connect with a study center
Kantonsspital Aarau, Neurozentrum
Aarau, 5001
SwitzerlandSite Not Available
RehaClinic AG
Bad Zurzach, 5330
SwitzerlandSite Not Available
Kantonsspital Baden
Baden, 5404
SwitzerlandSite Not Available
Felix Platter Spital
Basel, 4002
SwitzerlandSite Not Available
Stroke-Center Universitätsspital Basel
Basel,
SwitzerlandSite Not Available
Inselspital, Universitätsklinik für Neurologie
Bern, 3010
SwitzerlandSite Not Available
Kantonsspital Graubünden, Departement Innere Medizin / Neurologie
Chur, 7000
SwitzerlandSite Not Available
HFR Fribourg Hopital Cantonal, U. de Neurologie
Fribourg, 1708
SwitzerlandSite Not Available
Centre hospitalier universitaire vaudois, Service de Neurologie
Lausanne, 1011
SwitzerlandSite Not Available
Luzerner Kantonsspital, Klinik für Neurologie und Neurorehabilitation
Luzern 16, 6000
SwitzerlandSite Not Available
HFR Meyriez-Murten, Clinique de Réhabilitation
Meyriez, 3280
SwitzerlandSite Not Available
Kantonsspital Münsterlingen
Münsterlingen, 8596
SwitzerlandSite Not Available
Reha Rheinfelden
Rheinfelden, 4310
SwitzerlandSite Not Available
Hôpital du Valais - Sion
Sion, 1950
SwitzerlandSite Not Available
Hôpital du Valais - Sion, Service de neurologie
Sion, 1950
SwitzerlandSite Not Available
Kantonsspital St.Gallen, Klinik für Neurologie
St.Gallen, 9007
SwitzerlandSite Not Available
Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation
Valens, 7317
SwitzerlandSite Not Available
Cereneo Schweiz AG
Vitznau, 6354
SwitzerlandSite Not Available
Zürcher RehaZentrum Wald
Wald, 8636
SwitzerlandSite Not Available
Rheinburg Klinik AG
Walzenhausen, 9428
SwitzerlandSite Not Available
Kantonsspital Winterthur
Winterthur, 8401
SwitzerlandSite Not Available
Rehaklinik Zihlschlacht
Zihlschlacht, 8588
SwitzerlandSite Not Available
Head Stroke Center Klinik Hirslanden
Zürich, 8032
SwitzerlandSite Not Available
Klinik Lengg AG
Zürich, 8008
SwitzerlandSite Not Available
Universitätsspital Zürich, Klinik für Neurologie
Zürich, 8091
SwitzerlandSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.