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RESPECT-ETBNCT05691244

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

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Record History

All 24 versions: 24 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 54 → 57 locations
  2. Primary completion pushed from Sep 2026 to Sep 2027 Show 5 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Study completion pushed from Nov 2026 to Dec 2027
    • Secondary endpoints: details revised at 1 of 10 entries
    • Site details revised at 6 of 54 sites
    • Publications: details revised at 15 of 15 entries
  3. Study sites: 55 to 54v22
  4. Trial sites expanded: 42 → 55 locationsv21
  5. Study sites revised (42)v20
Show 18 earlier versionsHide 18 earlier versions
  1. Study sites: 37 to 42v19
  2. Study sites: 32 to 37v18
  3. Study sites: 30 to 32v17
  4. Study sites: 26 to 30v16
  5. Study sites: 25 to 26v15
  6. Site details revised at 3 of 25 sitesv14
  7. Study sites: 18 to 25v13
  8. Start date changed from estimate of Jul 26, 2025 to Jul 24, 2025v12
  9. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2025 to Jul 26, 2025
    • Site details revised at 18 of 18 sites
    v11
  10. Study sites: 14 to 18v10
  11. Study sites: 6 to 14
    • Start date: Jun 2025 to Jul 1, 2025
    v9
  12. Start date: Jan 2025 to Jun 2025v8 Show 5 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 5 words
    • Study sites: 0 to 6
    • Primary completion date: Aug 2026 to Sep 2026
    • Secondary endpoints revised (10)
  13. Start date: Nov 2024 to Jan 2025
    • Publications: 14 to 15
    v7
  14. Primary completion date: Aug 2025 to Aug 2026v6 Show 7 more changesShow less
    • Start date: Nov 2023 to Nov 2024
    • Eligibility criteria expanded, about 45 words
    • Primary endpoint revised
    • Enrollment target: 444 to 514
    • Study completion date: Nov 2025 to Nov 2026
    • Secondary endpoints: 9 to 10
    • Publications: 12 to 14
  15. Start date: Aug 2023 to Nov 2023
    • Secondary endpoints: 10 to 9
    v5
  16. Secondary endpoints revised (10)v4
  17. Start date: May 2023 to Aug 2023
    • Primary completion date: Apr 2025 to Aug 2025
    • Study completion date: Jul 2025 to Nov 2025
    v3
  18. Primary completion date: Mar 2025 to Apr 2025v2 Show 5 more changesShow less
    • Study completion date: Jun 2025 to Jul 2025
    • Start date: Apr 2023 to May 2023
    • Secondary endpoints: 9 to 10
    • Study description shortened, about 4 words
    • Study title shortened, about 3 words
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Determine the efficacy of sovateltide in patients with acute cerebral ischemic stroke assessed by modified Rankin Scale (mRS) score of 0-2 at day 90 post-randomization.
Timeframe: Day 1 through Day 90

Secondary (10)

Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the National Institute of Health Stroke Scale (NIHSS) score of <6 at day 90 post-randomization.
Determine a good functional outcome in patients with acute cerebral ischemic stroke assessed by the Barthel Index (BI) score of ≥90 at day 90 post-randomization.
Determine an excellent functional outcome in patients with acute cerebral ischemic stroke assessed by a modified Rankin Scale score of 0-1 at day 90 post-randomization.
Determine a change in Quality-of-life (QoL) as assessed by EuroQol-EQ-5D-5L and Stroke-Specific Quality of Life (SS-QOL) at days 30, 60, and 90 post-randomization.
Determine the incidence of recurrent cerebral ischemic stroke within 90 days post-randomization.
Show 5 moreShow less
Determine the incidence of mortality within 90 days post-randomization.
Determine the incidence of symptomatic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization.
Determine the incidence of radiographic Intracerebral Hemorrhage (ICH) within 24 (± 6) hours of randomization.
Determine alteration in cognition at days 30 and 90 measured by Montreal Cognitive Assessment (MoCA) Test.
Determine any adverse events (AE) or serious adverse events (SAEs) are associated with sovateltide.

Arms and interventions

Normal Saline + Standard of careActive comparator

Normal saline will be used as a comparator. It will be available in a 5.0 mL vial. Three doses will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

Sovateltide + Standard of careExperimental

The test product is sovateltide. It is available as a lyophilized injection containing 30 µg of sovateltide in a 5.0 mL vial. Three doses of 0.3 μg/kg will be administered as an IV bolus over one minute every 3 hours ± 1 hour on day 1. The dose will be repeated on days 3 and 6 post randomization. The study drug will be administered as an IV bolus dose over 1 minute within 24 hours of the stroke onset.

Drugs: Drug: Normal Saline, Sovateltide

Sites

57 sites in 5 countries

Spain 20, United States 16, Germany 11, United Kingdom 9, Australia 1