Levodopa Added to Stroke Rehabilitation: The ESTREL Randomized Clinical Trial
Levodopa enhances dopaminergic signaling and may stimulate neuroplasticity, which could potentially enhance motor recovery after stroke. Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness. To determine whether levodopa compared with placebo, administered in additi...
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| Veröffentlicht in: | JAMA : the journal of the American Medical Association Jg. 334; H. 17; S. 1523 |
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| Format: | Journal Article |
| Sprache: | Englisch |
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United States
04.11.2025
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| ISSN: | 1538-3598, 1538-3598 |
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| Abstract | Levodopa enhances dopaminergic signaling and may stimulate neuroplasticity, which could potentially enhance motor recovery after stroke. Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness.
To determine whether levodopa compared with placebo, administered in addition to standardized rehabilitation based on active task-oriented training, is associated with enhanced motor recovery in patients with acute stroke.
A double-blind, placebo-controlled randomized clinical trial at 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland. Between June 14, 2019 (first patient, first visit), and August 27, 2024 (last patient, last visit), 610 patients with acute ischemic or hemorrhagic stroke with clinically meaningful hemiparesis (ie, a total score of ≥3 points on the following National Institutes of Health Stroke Scale items: motor arm, motor leg, or limb ataxia) were randomized 1:1 to receive levodopa or placebo. Statistical analyses were conducted from November 2024 to August 2025.
Patients received levodopa/carbidopa (100 mg/25 mg; n = 307) or placebo (n = 303) 3 times daily for 39 days, alongside standardized rehabilitation therapy based on active task-oriented training.
The primary outcome was the adjusted mean between-group difference in the Fugl-Meyer Assessment (FMA) total score (range, 0-100 points; fewer points indicate worse motor function; 6-point difference considered patient-relevant) at 3 months.
Among the 610 participants (median [IQR] age, 73 [64-82] years; 252 [41.3%] female; median baseline FMA total score, 34 [14-54]), 28 participants died by 3 months, leaving 582 (95.4%) participants eligible for the primary analysis. At 3 months, the median (IQR) FMA total score was 68 (42-85) points in the levodopa group and 64 (44-83) points in the placebo group. The mean difference in the FMA total score between the levodopa and placebo groups was -0.90 points (95% CI, -3.78 to 1.98; P = .54). There were 126 serious adverse events in the levodopa group and 129 in the placebo group; the most common was infection (levodopa, n = 55; placebo, n = 44).
In this randomized clinical trial, among patients receiving inpatient rehabilitation for acute stroke, levodopa added to standardized rehabilitation did not significantly improve motor function at 3 months compared with placebo plus standardized rehabilitation. These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke.
ClinicalTrials.gov Identifier: NCT03735901. |
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| AbstractList | Levodopa enhances dopaminergic signaling and may stimulate neuroplasticity, which could potentially enhance motor recovery after stroke. Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness.
To determine whether levodopa compared with placebo, administered in addition to standardized rehabilitation based on active task-oriented training, is associated with enhanced motor recovery in patients with acute stroke.
A double-blind, placebo-controlled randomized clinical trial at 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland. Between June 14, 2019 (first patient, first visit), and August 27, 2024 (last patient, last visit), 610 patients with acute ischemic or hemorrhagic stroke with clinically meaningful hemiparesis (ie, a total score of ≥3 points on the following National Institutes of Health Stroke Scale items: motor arm, motor leg, or limb ataxia) were randomized 1:1 to receive levodopa or placebo. Statistical analyses were conducted from November 2024 to August 2025.
Patients received levodopa/carbidopa (100 mg/25 mg; n = 307) or placebo (n = 303) 3 times daily for 39 days, alongside standardized rehabilitation therapy based on active task-oriented training.
The primary outcome was the adjusted mean between-group difference in the Fugl-Meyer Assessment (FMA) total score (range, 0-100 points; fewer points indicate worse motor function; 6-point difference considered patient-relevant) at 3 months.
Among the 610 participants (median [IQR] age, 73 [64-82] years; 252 [41.3%] female; median baseline FMA total score, 34 [14-54]), 28 participants died by 3 months, leaving 582 (95.4%) participants eligible for the primary analysis. At 3 months, the median (IQR) FMA total score was 68 (42-85) points in the levodopa group and 64 (44-83) points in the placebo group. The mean difference in the FMA total score between the levodopa and placebo groups was -0.90 points (95% CI, -3.78 to 1.98; P = .54). There were 126 serious adverse events in the levodopa group and 129 in the placebo group; the most common was infection (levodopa, n = 55; placebo, n = 44).
In this randomized clinical trial, among patients receiving inpatient rehabilitation for acute stroke, levodopa added to standardized rehabilitation did not significantly improve motor function at 3 months compared with placebo plus standardized rehabilitation. These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke.
ClinicalTrials.gov Identifier: NCT03735901. Levodopa enhances dopaminergic signaling and may stimulate neuroplasticity, which could potentially enhance motor recovery after stroke. Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness.ImportanceLevodopa enhances dopaminergic signaling and may stimulate neuroplasticity, which could potentially enhance motor recovery after stroke. Levodopa is used in stroke rehabilitation despite mixed evidence for its effectiveness.To determine whether levodopa compared with placebo, administered in addition to standardized rehabilitation based on active task-oriented training, is associated with enhanced motor recovery in patients with acute stroke.ObjectiveTo determine whether levodopa compared with placebo, administered in addition to standardized rehabilitation based on active task-oriented training, is associated with enhanced motor recovery in patients with acute stroke.A double-blind, placebo-controlled randomized clinical trial at 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland. Between June 14, 2019 (first patient, first visit), and August 27, 2024 (last patient, last visit), 610 patients with acute ischemic or hemorrhagic stroke with clinically meaningful hemiparesis (ie, a total score of ≥3 points on the following National Institutes of Health Stroke Scale items: motor arm, motor leg, or limb ataxia) were randomized 1:1 to receive levodopa or placebo. Statistical analyses were conducted from November 2024 to August 2025.Design, Setting, and ParticipantsA double-blind, placebo-controlled randomized clinical trial at 13 stroke units and centers and 11 collaborating rehabilitation centers in Switzerland. Between June 14, 2019 (first patient, first visit), and August 27, 2024 (last patient, last visit), 610 patients with acute ischemic or hemorrhagic stroke with clinically meaningful hemiparesis (ie, a total score of ≥3 points on the following National Institutes of Health Stroke Scale items: motor arm, motor leg, or limb ataxia) were randomized 1:1 to receive levodopa or placebo. Statistical analyses were conducted from November 2024 to August 2025.Patients received levodopa/carbidopa (100 mg/25 mg; n = 307) or placebo (n = 303) 3 times daily for 39 days, alongside standardized rehabilitation therapy based on active task-oriented training.InterventionPatients received levodopa/carbidopa (100 mg/25 mg; n = 307) or placebo (n = 303) 3 times daily for 39 days, alongside standardized rehabilitation therapy based on active task-oriented training.The primary outcome was the adjusted mean between-group difference in the Fugl-Meyer Assessment (FMA) total score (range, 0-100 points; fewer points indicate worse motor function; 6-point difference considered patient-relevant) at 3 months.Main Outcomes and MeasuresThe primary outcome was the adjusted mean between-group difference in the Fugl-Meyer Assessment (FMA) total score (range, 0-100 points; fewer points indicate worse motor function; 6-point difference considered patient-relevant) at 3 months.Among the 610 participants (median [IQR] age, 73 [64-82] years; 252 [41.3%] female; median baseline FMA total score, 34 [14-54]), 28 participants died by 3 months, leaving 582 (95.4%) participants eligible for the primary analysis. At 3 months, the median (IQR) FMA total score was 68 (42-85) points in the levodopa group and 64 (44-83) points in the placebo group. The mean difference in the FMA total score between the levodopa and placebo groups was -0.90 points (95% CI, -3.78 to 1.98; P = .54). There were 126 serious adverse events in the levodopa group and 129 in the placebo group; the most common was infection (levodopa, n = 55; placebo, n = 44).ResultsAmong the 610 participants (median [IQR] age, 73 [64-82] years; 252 [41.3%] female; median baseline FMA total score, 34 [14-54]), 28 participants died by 3 months, leaving 582 (95.4%) participants eligible for the primary analysis. At 3 months, the median (IQR) FMA total score was 68 (42-85) points in the levodopa group and 64 (44-83) points in the placebo group. The mean difference in the FMA total score between the levodopa and placebo groups was -0.90 points (95% CI, -3.78 to 1.98; P = .54). There were 126 serious adverse events in the levodopa group and 129 in the placebo group; the most common was infection (levodopa, n = 55; placebo, n = 44).In this randomized clinical trial, among patients receiving inpatient rehabilitation for acute stroke, levodopa added to standardized rehabilitation did not significantly improve motor function at 3 months compared with placebo plus standardized rehabilitation. These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke.Conclusions and RelevanceIn this randomized clinical trial, among patients receiving inpatient rehabilitation for acute stroke, levodopa added to standardized rehabilitation did not significantly improve motor function at 3 months compared with placebo plus standardized rehabilitation. These results do not support the use of levodopa as an adjunct to rehabilitation therapy for enhancing motor recovery after acute stroke.ClinicalTrials.gov Identifier: NCT03735901.Trial RegistrationClinicalTrials.gov Identifier: NCT03735901. |
| Author | Luft, Andreas R Tarnutzer, Alexander A Engelter, Stefan T Sandor, Peter S Auer, Elias De Marchis, Gian Marco Van Den Keybus Deglon, Katrien Wiegert, Martina Katan, Mira Möller, J Carsten Kägi, Georg Accolla, Ettore A Chabwine, Joelle N Held, Jeremia P O Ford, Gary A Kaufmann, Josefin E Schuster-Amft, Corina Müri, René M Schädelin, Sabine Polymeris, Alexandros Salerno, Alexander Hemkens, Lars G Seiffge, David J Traenka, Christopher Rapin, Pierre-André Schär, Janine Bujan, Bartosz Rottenberger, Yannik Fischer, Urs Medlin, Friedrich Jedrysiak, Piotr Lippert, Julian Sturzenegger, Rolf Wiesner, Karin Nedeltchev, Krassen Lienert, Carmen Zietz, Annaelle Michel, Patrik Schwarz, Anne Bonati, Leo H Schweinfurther, Raoul Gensicke, Henrik Peters, Nils Foucras, Sandrine Lyrer, Philippe A Politz, Svetlana Humm, Andrea Altersberger, Valerian L Greulich, Matthias Gonzenbach, Roman Lutz, Dietmar Mylius, Veit Gäumann, Szabina |
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Division, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts – sequence: 6 givenname: Valerian L surname: Altersberger fullname: Altersberger, Valerian L organization: Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia – sequence: 7 givenname: Karin surname: Wiesner fullname: Wiesner, Karin organization: Department of Rehabilitation and Neurology, University Department of Geriatric Medicine FELIX PLATTER, University of Basel, Basel, Switzerland – sequence: 8 givenname: Martina surname: Wiegert fullname: Wiegert, Martina organization: Department of Neurology and Stroke Center, Department of Clinical Research, University Hospital Basel and University of Basel, Basel, Switzerland – sequence: 9 givenname: Jeremia P O surname: Held fullname: Held, Jeremia P O organization: Bellevue Medical Group, Zurich, Switzerland – sequence: 10 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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/40982270$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Contributor | Esteves, Melissa Müller, Madlaine Tarnutzer, Alexander Taheri, Shadi Kaufmann, Eveline Auer, Elias Avramiotis, Nikolaos Symeon Wagner, Benjamin Berney, Loric Drop, Boudewijn Sauter, Mirjam Engelter, Stefan Beyeler, Morin Eskandari, Ashraf Rieger, Steven Rauch, Janis Patricia Liechti, Yasmin Huser, Marion Kahles, Timo Eberle, Grégoire Nussbaum, Lukas Salerno, Alexander Thevoz, Guillaume Nussbaumer, Larissa Zbinden, Céline Schär, Janine Clarke, Sandra Medlin, Friedrich Brunner, Eveline Maurer, Marina Wiesner, Karin Nedeltchev, Krassen Lange, Martin Boos, Lukas Zietz, Annaelle Tentolouris Piperas, Vasileios Bleuler, Barbara Peters, Nils Foucras, Sandrine Wehrli, Carina Buehrer, Manuela Kamerbeek Verhagen, Wilma Fladt, Joachim Schneider, Iris Brückner, Yvonne Duc, Aline Lyrer, Philippe Remillard, Suzette Strambo, Davide Stohr, Romain Silimon, Norbert De Marchis, Gian Marco Maslias, Errikos Van Den Keybus Deglon, Katrien Diserens, Karin Spring, Sabine Piot, Ines Wiegert, Martina Katan, Mira Müller, Maja Fischer, Sandro Maamari, Basel Cottier, Elodie Tr |
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