Enhancement of Stroke Rehabilitation With Levodopa (ESTREL)

University Hospital Basel

Status and phase: Active, not recruiting; Phase 3

Conditions: Stroke Rehabilitation; Acute Stroke

Treatments: Drug: IMP Levodopa 100mg/Carbidopa 25mg; Drug: Matching placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03735901

2018-02021 me16Engelter;

Details and patient eligibility

About

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.

Full 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.

Enrollment: 610 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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610 participants in 2 patient groups, including a placebo group

Experimental Intervention

Active Comparator group

Description:

White Investigational Medicinal Product (IMP)- capsules of a combination of IMP Levodopa 100mg/Carbidopa 25mg.

Treatment:

Drug: IMP Levodopa 100mg/Carbidopa 25mg

Control Intervention

Placebo Comparator group

Description:

Matching placebo, identical in aspect, texture, and taste when compared to the IMP. Procedures regarding route of administration, study treatment duration and treatment phases will be identical in the IMP- and the placebo-group.

Treatment:

Drug: Matching placebo