Enhancement of Stroke Rehabilitation With Levodopa

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    610
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 24 February 2021

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.

Description

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

  1. 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.
  2. 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 or serious adverse events).

Details
Condition Cerebrovascular accident, Acute Ischemic Stroke, Stroke Rehabilitation, Stroke, acute stroke
Treatment Matching Placebo, IMP Levodopa 100mg/Carbidopa 25mg
Clinical Study IdentifierNCT03735901
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on24 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Acute ischemic or hemorrhagic (i.e. intracerebral hemorrhage excluding subarachnoid hemorrhage and cerebal 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 postmenopausal for longer than 2 years are not considered as being of child- bearing potential
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