Home Ischemic Stroke Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial

Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial

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 Ask your doctor what they are using levodopa for in your recovery.  No knowledge is grounds for firing.

Early Promise For Stroke Patients Given – levodopa  back to Sept. 2001.

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Enhancement of STroke REhabilitation with Levodopa (ESTREL): Rationale and design of a randomized placebo-controlled, double blind superiority trial

Annaelle Zietz https://orcid.org/0000-0002-4362-2497, Josefin E Kaufmann https://orcid.org/0000-0001-7744-2796 for the ESTREL InvestigatorsView all authors and affiliations
OnlineFirst
https://doi.org/10.1177/23969873241255867

Abstract

Rationale:

Novel
therapeutic approaches are needed in stroke recovery. Whether
pharmacological therapies are beneficial for enhancing stroke recovery
is unclear. Dopamine is a neurotransmitter involved in motor learning,
reward, and brain plasticity. Its prodrug levodopa is a promising agent
for stroke recovery.

Aim and hypothesis:

To
investigate the hypothesis that levodopa, in addition to standardized
rehabilitation therapy based on active task training, results in an
enhancement of functional recovery in acute ischemic or hemorrhagic
stroke patients compared to placebo.

Design:

ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a randomized (ratio 1:1), multicenter, placebo-controlled, double-blind, parallel-group superiority trial.

Participants:

610
participants (according to sample size calculation) with a clinically
meaningful hemiparesis will be enrolled ⩽7 days after stroke onset. Key
eligibility criteria include (i) in-hospital-rehabilitation required,
(ii) capability to participate in rehabilitation, (iii) previous
independence in daily living.

Intervention:

Levodopa
100 mg/carbidopa 25 mg three times daily, administered for 5 weeks in
addition to standardized rehabilitation. The study intervention will be
initiated within 7 days after stroke onset.

Comparison:

Matching placebo plus standardized rehabilitation.

Outcomes:

The
primary outcome is the between-group difference of the Fugl-Meyer-Motor
Assessment (FMMA) total score measured 3 months after randomization.
Secondary outcomes include patient-reported health and wellbeing (PROMIS
10 and 29), patient-reported assessment of improvement, Rivermead
Mobility Index, modified Rankin Scale, National Institutes of Health
Stroke Scale (NIHSS), and as measures of harm: mortality, recurrent
stroke, and serious adverse events.

Conclusion:

The
ESTREL trial will provide evidence of whether the use of Levodopa in
addition to standardized rehabilitation in stroke patients leads to
better functional recovery compared to rehabilitation alone.



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