Enhancement of Stroke Rehabilitation With Levodopa

Last updated: October 14, 2024
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Not Recruiting

Phase

3

Condition

Stroke

Cerebral Ischemia

Treatment

IMP Levodopa 100mg/Carbidopa 25mg

Matching placebo

Clinical Study ID

NCT03735901
2018-02021; me16Engelter
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 610
Treatment Group(s): 2
Primary Treatment: IMP Levodopa 100mg/Carbidopa 25mg
Phase: 3
Study Start date:
June 14, 2019
Estimated Completion Date:
June 30, 2029

Study Description

Trial investigates whether Levodopa/Carbidopa compared to placebo given in addition to standardized rehabilitative therapy in patients with acute stroke is associated with

a) patient relevant improvements of physical function b) improvement in patient-self assessed general health aspects, pain, mood, anxiety, fatigue and social participation c) long-term sustainability of a patient-relevant improvement of motor function d) improvement of selective hand and wrist movement e) a higher rate of patients walking independently of the help of another person.

f) less severe impairment g) a higher level of activity of daily living h) improvements of quality of life (i) better cognitive performance (j) no signals of harms (i.e. indications for increased all-cause mortality, recurrent stroke, serious adverse events, and non-serious, pre-specified adverse events possibly related to the IMP)

Estrel-Longterm: optional prolongation of the observational study phase. To investigate the long-term outcomes of our study population the investigator aim to offer an optional prolongation of the observational phase to the participants through regular structured (once yearly) telephone visits.

The telephone visits will be carried out annually for the following 4 years.

Connect with a study center

  • Kantonsspital Aarau, Neurozentrum

    Aarau, 5001
    Switzerland

    Site Not Available

  • RehaClinic AG

    Bad Zurzach, 5330
    Switzerland

    Site Not Available

  • Kantonsspital Baden

    Baden, 5404
    Switzerland

    Site Not Available

  • Felix Platter Spital

    Basel, 4002
    Switzerland

    Site Not Available

  • Stroke-Center Universitätsspital Basel

    Basel,
    Switzerland

    Site Not Available

  • Inselspital, Universitätsklinik für Neurologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Kantonsspital Graubünden, Departement Innere Medizin / Neurologie

    Chur, 7000
    Switzerland

    Site Not Available

  • HFR Fribourg Hopital Cantonal, U. de Neurologie

    Fribourg, 1708
    Switzerland

    Site Not Available

  • Centre hospitalier universitaire vaudois, Service de Neurologie

    Lausanne, 1011
    Switzerland

    Site Not Available

  • Luzerner Kantonsspital, Klinik für Neurologie und Neurorehabilitation

    Luzern 16, 6000
    Switzerland

    Site Not Available

  • HFR Meyriez-Murten, Clinique de Réhabilitation

    Meyriez, 3280
    Switzerland

    Site Not Available

  • Kantonsspital Münsterlingen

    Münsterlingen, 8596
    Switzerland

    Site Not Available

  • Reha Rheinfelden

    Rheinfelden, 4310
    Switzerland

    Site Not Available

  • Hôpital du Valais - Sion

    Sion, 1950
    Switzerland

    Site Not Available

  • Hôpital du Valais - Sion, Service de neurologie

    Sion, 1950
    Switzerland

    Site Not Available

  • Kantonsspital St.Gallen, Klinik für Neurologie

    St.Gallen, 9007
    Switzerland

    Site Not Available

  • Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation

    Valens, 7317
    Switzerland

    Site Not Available

  • Cereneo Schweiz AG

    Vitznau, 6354
    Switzerland

    Site Not Available

  • Zürcher RehaZentrum Wald

    Wald, 8636
    Switzerland

    Site Not Available

  • Rheinburg Klinik AG

    Walzenhausen, 9428
    Switzerland

    Site Not Available

  • Kantonsspital Winterthur

    Winterthur, 8401
    Switzerland

    Site Not Available

  • Rehaklinik Zihlschlacht

    Zihlschlacht, 8588
    Switzerland

    Site Not Available

  • Head Stroke Center Klinik Hirslanden

    Zürich, 8032
    Switzerland

    Site Not Available

  • Klinik Lengg AG

    Zürich, 8008
    Switzerland

    Site Not Available

  • Universitätsspital Zürich, Klinik für Neurologie

    Zürich, 8091
    Switzerland

    Site Not Available

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