Enhancement of Stroke Rehabilitation With Levodopa

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Swiss National Science Foundation
• Treatments: Carbidopa; Levodopa

Criteria

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 post- menopausal for longer than 2 years are not considered as being of child- bearing potential.