drugset / Trial / NCT03735901
Enhancement of Stroke Rehabilitation With Levodopa
Phase 3
Active not recruiting
610 enrolled
University Hospital, Basel, Switzerland
Swiss National Science Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-06-14
- Primary completion
- 2024-08-27
- Completion
- 2029-06-30
Publications
- Sauter MI, Kaufmann JE, Boos L, Zietz A, Trussel S, Luft AR, Polymeris A, Altersberger VL, Wiesner K, Wiegert M, Held JPO, Rottenberger Y, Schwarz A, Medlin F, Accolla EA, Foucras S, Kagi G, De Marchis GM, Politz S, Greulich M, Tarnutzer AA, Sturzenegger R, Katan M, Arnold M, Nedeltchev K, Schar J, Deglon KVDK, Rapin PA, Salerno A, Seiffge DJ, Auer E, Lippert J, Bonati LH, Schuster-Amft C, Gaumann S, Chabwine JN, Humm A, Moller JC, Schweinfurther R, Bujan B, Jedrysiak P, Sandor PS, Gonzenbach R, Mylius V, Lutz D, Lienert C, Peters N, Michel P, Muri RM, Schadelin S, Hemkens LG, Ford GA, Lyrer PA, Gensicke H, Traenka C, Engelter ST. The impact of levodopa on post-stroke depression: the ESTREL-depression-study. Eur Stroke J. 2026 Feb 9;11(2):aakag001. doi: 10.1093/esj/aakag001.
- Engelter ST, Kaufmann JE, Zietz A, Luft AR, Polymeris A, Altersberger VL, Wiesner K, Wiegert M, Held JPO, Rottenberger Y, Schwarz A, Medlin F, Accolla EA, Foucras S, Kagi G, De Marchis GM, Politz S, Greulich M, Tarnutzer AA, Sturzenegger R, Katan M, Fischer U, Nedeltchev K, Schar J, Van Den Keybus Deglon K, Rapin PA, Salerno A, Seiffge DJ, Auer E, Lippert J, Bonati LH, Schuster-Amft C, Gaumann S, Chabwine JN, Humm A, Moller JC, Schweinfurther R, Bujan B, Jedrysiak P, Sandor PS, Gonzenbach R, Mylius V, Lutz D, Lienert C, Peters N, Michel P, Muri RM, Schadelin S, Hemkens LG, Ford GA, Lyrer PA, Gensicke H, Traenka C; ESTREL Investigators. Levodopa Added to Stroke Rehabilitation: The ESTREL Randomized Clinical Trial. JAMA. 2025 Nov 4;334(17):1523-1532. doi: 10.1001/jama.2025.15185.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbidopa | Unknown | 25 mg | — |
| Comparator | Levodopa | Small molecule | 100 mg | — |