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Enhancement of Stroke Rehabilitation With Levodopa

Study acronym: ESTREL
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Aug 31, 2024 to Aug 27, 2024
    • Study completion date: Dec 31, 2028 to Jun 30, 2029
    • Site details revised at 24 of 24 sites
    v17
  2. Primary endpoint revised
    • Eligibility criteria revised
    • Secondary endpoints revised (20)
    v16
  3. Secondary endpoints: 21 to 20
    • Study description expanded, about 9 words
    v15
  4. Site details revised at 2 of 24 sitesv14
  5. Primary completion date: Dec 31, 2022 to Aug 31, 2024
    • Study completion date: Dec 31, 2022 to Dec 31, 2028
    • Secondary endpoints: details revised at 6 of 21 entries
    • Study description expanded, about 52 words
    v13
Show 11 earlier versionsHide 11 earlier versions
  1. Re-verified, no change to tracked fieldsv12
  2. Secondary endpoints: 20 to 21v11
  3. Secondary endpoints revised (20)
    • Study description expanded, about 5 words
    v10
  4. Study sites revised (24)v9
  5. Eligibility criteria expanded, about 128 words
    • Study description shortened, about 1 word
    v8
  6. Re-verified, no change to tracked fieldsv7
  7. Study sites: 3 to 24
    • Secondary endpoints: details revised at 1 of 20 entries
    v6
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 1, 2019 to Jun 14, 2019
    • Site details revised at 3 of 3 sites
    v5
  9. Start date: Apr 1, 2019 to Jun 1, 2019v4
  10. Start date: Feb 1, 2019 to Apr 1, 2019v3
  11. Secondary endpoints revised (20)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03735901
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: Swiss National Science Foundation
Conditions
(from sponsor)		 Acute Stroke, Stroke Rehabilitation
Related terms Ischemic Stroke, Stroke
Enrollment 610 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov