NCT03735901

Enhancement of Stroke Rehabilitation With Levodopa

Enhancement of Stroke Rehabilitation With Levodopa (ESTREL): a Randomized Placebo-controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 610 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Stroke
• Stroke Rehabilitation

Interventions

Type	Name	Description
DRUG	IMP Levodopa 100mg/Carbidopa 25mg	Study treatment will comprise 3 phases: 1. Dose escalation phase: On day 1-3, patients will receive IMP solely in the morning; on day 4-6 in the morning and at lunch time; 2. full study treatment phase: from day 7 to day 34, 3 times per day (tid). 3. Treatment will stop with a tapering phase: On day 35-37, patients will receive IMP in the morning and at lunch time; on day 38 and 39 solely in the morning.
DRUG	Matching placebo	Study treatment will comprise 3 phases: 1. Dose escalation phase: On day 1-3, patients will receive Placebo solely in the morning; on day 4-6 in the morning and at lunch time; 2. full study treatment phase: from day 7 to day 34, Placebo capsules 3 times per day (tid). 3. Treatment will stop with a tapering phase: On day 35-37, patients will receive Placebo in the morning and at lunch time; on day 38 and 39 solely in the morning.

Timeline

• Start date: 2019-06-14
• Primary completion: 2024-08-27
• Completion: 2029-06-30
• First posted: 2018-11-08
• Last updated: 2024-10-15

Locations

24 sites across 1 country: Switzerland