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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kantonsspital Aarau, Neurozentrum Coordinator of this site? Confirm its status | Aarau | Switzerland | Unknown status |
| Kantonsspital Baden Coordinator of this site? Confirm its status | Baden | Switzerland | Unknown status |
| RehaClinic AG Coordinator of this site? Confirm its status | Bad Zurzach | Switzerland | Unknown status |
| Felix Platter Spital Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Stroke-Center Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| Inselspital Universitätsklinik für Neurologie Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| Kantonsspital Graubünden, Departement Innere Medizin / Neurologie Coordinator of this site? Confirm its status | Chur | Switzerland | Unknown status |
| HFR Fribourg Hopital Cantonal, U. de Neurologie Coordinator of this site? Confirm its status | Fribourg | Switzerland | Unknown status |
| Centre hospitalier universitaire vaudois, Service de Neurologie Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| HFR Meyriez-Murten, Clinique de Réhabilitation Coordinator of this site? Confirm its status | Meyriez | Switzerland | Unknown status |
| Kantonsspital Münsterlingen Coordinator of this site? Confirm its status | Münsterlingen | Switzerland | Unknown status |
| Reha Rheinfelden Coordinator of this site? Confirm its status | Rheinfelden | Switzerland | Unknown status |
| Kantonsspital St.Gallen, Klinik für Neurologie Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Hôpital du Valais - Sion, Service de neurologie Coordinator of this site? Confirm its status | Sion | Switzerland | Unknown status |
| Hôpital du Valais - Sion Coordinator of this site? Confirm its status | Sion | Switzerland | Unknown status |
| Rehazentrum Valens, Klinik für Neurologie und Neurorehabilitation Coordinator of this site? Confirm its status | Valens | Switzerland | Unknown status |
| Cereneo Schweiz AG Coordinator of this site? Confirm its status | Vitznau | Switzerland | Unknown status |
| Zürcher RehaZentrum Wald Coordinator of this site? Confirm its status | Wald | Switzerland | Unknown status |
| Rheinburg Klinik AG Coordinator of this site? Confirm its status | Walzenhausen | Switzerland | Unknown status |
| Kantonsspital Winterthur Coordinator of this site? Confirm its status | Winterthur | Switzerland | Unknown status |
| Rehaklinik Zihlschlacht Coordinator of this site? Confirm its status | Zihlschlacht | Switzerland | Unknown status |
| Klinik Lengg AG Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Head Stroke Center Klinik Hirslanden Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Universitätsspital Zürich, Klinik für Neurologie Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
Related publications
- Time course of motor recovery after stroke with and without levodopa: a post hoc 6-month longitudinal analysis of the ESTREL trial.Eur Stroke J · 2026 · PMID 42525438
- The impact of levodopa on post-stroke depression: the ESTREL-depression-study.Eur Stroke J · 2026 · PMID 41701756
This page is information, not medical advice. Discuss any trial with your doctor.