ESTREL study: Improving post-stroke rehabilitation with levodopa: a randomized, placebo-controlled study
Résumé de l'étude
This study will be conducted at several centers in Switzerland with approximately 610 patients carried out. The study will last a total of 3.5 years, the individual patient will participate for 3 months, with the request also at the follow-up period of 9 months to participate. It is randomly determined (randomized) whether the patient receives the study drug or a similar-looking dummy drug without an active ingredient (placebo). The chance to be divided into one of the groups is 1: 1. Neither the patient nor the study staff knows in which treatment group the patient is divided (double-blind). The active substance levodopa has been available on the market for many decades and is used to treat Parkinson's disease. In this study, he is being tested for the treatment of a new disease (indication extension). For this treatment levodopa is not approved in the market. In this study levodopa is used in a similar dosage as in the treatment of Parkinson's disease. For the patient, the study begins during his stay in the Stroke Unit and continues in the rehabilitation facility. After an initial examination he will be on 39 consecutive days in addition to
(BASEC)
Intervention étudiée
The study is investigating the improvement in the treatment of post-stroke paralysis. We are doing this study to show that the active ingredient levodopa helps improve the success of patient rehabilitation compared to a placebo.
(BASEC)
Maladie en cours d'investigation
Stroke with signs of paralysis
(BASEC)
Anyone over the age of 18 who has had a stroke in the last 7 days and has a hemiparic clinically relevant paralysis may attend. If clot-dissolving therapy (thrombolysis) or clot removal with a catheter has been used, a waiting period of 24 hours before admission to the study must have elapsed. Inpatient admission for further treatment in a rehabilitation center must be provided. It must be assumed that the patient can follow the instructions during the rehabilitation measures. (BASEC)
Critères d'exclusion
On the other hand, persons who had pre-existing hemiplegia, Parkinson's disease or are already in need of therapy with levodopa may not participate. If the communication is impaired to the extent that the person can not fulfill two-stage requests, or even before this stroke, no independent living was possible, the patient can not also participate. If an intolerance to any of the ingredients of the study drug is known or if there is a contraindication to the use of levodopa, the patient can not attend. Pregnant, breast-feeding and women of child-bearing potential who are unwilling to use a safe contraceptive while taking the study drug and for one month thereafter can not participate either. (BASEC)
Lieu de l’étude
Bâle
(BASEC)
Sponsor
Prof. Dr. Stefan Engelter
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Philippe Lyrer
+41 61 328 61 60
philippe.lyrer@clutterusb.chUniversitätsspital Basel (USB)
(BASEC)
Informations générales
Felix-Platter Spital Basel
(ICTRP)
Informations scientifiques
Felix-Platter Spital Basel
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
11.01.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT03735901 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Enhancement of stroke rehabilitation with Levodopa (ESTREL) (BASEC)
Titre académique
Enhancement of Stroke Rehabilitation With Levodopa (ESTREL): a Randomized Placebo-controlled Trial (ICTRP)
Titre public
Enhancement of Stroke Rehabilitation With Levodopa (ICTRP)
Maladie en cours d'investigation
Acute Stroke;Stroke Rehabilitation (ICTRP)
Intervention étudiée
Drug: IMP Levodopa 100mg/Carbidopa 25mg;Drug: Matching placebo (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- 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
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 to
study drug intake (orally, or via nasogastric tube or percutaneous endoscopic
gastrostomy tube)
- Severe aphasia (i.e. unable to follow two-stage-commands)
- Previously dependent in the basal activities of daily living (defined as modified
Ranking Scale prior to stroke > 3)
- Pre-existing hemiparesis
- Known hypersensitivity to Levodopa/Carbidopa and other contraindications for
Levodopa/Carbidopa as outlined in the summary of product characteristics
- 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.
- 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. (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Fugl-Meyer-Motor Assessment Score (FMMA) (ICTRP)
NIH-Stroke Scale Score (NIHSS);Modified Rankin Scale Score (mRS);Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 29;Stroke rehabilitation outcomes for disease specific morbidity and quality of life - PROMIS 10;Patient-reported assessment of relevance of motor improvement;Rivermead Mobility Index (RMI);Mortality (of any cause);Recurrent stroke (any type);Pre- specified Adverse Events of Interest;Motricity Index (MI);Trunk Control Test (TCT);Action Research Arm Test (ARAT);Box- and Block Test (BBT);Functional Ambulation Categories (FAC);Ten-Meter Walk Test (10MWT);Jamar dynamometer testing (JDT);Montreal Cognitive Assessment (MoCA);Daily activity measurement with movement sensor;Serious Adverse Event (SAE);Fugl-Meyer-Motor Assessment Score (FMMA) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation (ICTRP)
Contacts supplémentaires
Stefan Engelter, Prof. MD, Felix-Platter Spital Basel (ICTRP)
ID secondaires
2018-02021, me16Engelter (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03735901 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible