Clinical trial • Phase II • Neurology|Cardiology
LENOMORELIN for Ischemic stroke|Stroke
Phase II trial of LENOMORELIN for Ischemic stroke|Stroke.
Overview
- Trial Therapeutic Area
- Neurology|Cardiology
- Trial Disease
- Ischemic stroke|Stroke
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 17-09-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Randomised, intervention: acyl-ghreline (lenomorelin) 600 µg intravenously, twice daily for 5 days. comparator/control: standard care (no ghrelin). Phase II trial across 4 sites in Netherlands.
- Randomised
- Yes
- Comparator
- Intervention: Acyl-ghreline (lenomorelin) 600 µg intravenously, twice daily for 5 days. Comparator/control: standard care (no ghrelin).
- Target Sample Size
- 80
- Trial Duration For Participant
- 90
Eligibility
Recruits 80 Vulnerable population selected. The trial uses deferred written informed consent as indicated in the inclusion criteria ("written informed consent (deferred)"). Subject information and informed consent form (ICF) documents for deferred consent and ICFs for legal representatives are available (multiple L1 ICF and legal representative ICF documents listed)..
- Pregnancy Exclusion
- child-bearing potential
- Vulnerable Population
- Vulnerable population selected. The trial uses deferred written informed consent as indicated in the inclusion criteria ("written informed consent (deferred)"). Subject information and informed consent form (ICF) documents for deferred consent and ICFs for legal representatives are available (multiple L1 ICF and legal representative ICF documents listed).
Inclusion criteria
- {"criterion_text":"- a clinical diagnosis of acute ischemic stroke, caused by intracranial large vessel occlusion of the anterior circulation (distal intracranial carotid artery or middle (M1/proximal M2) cerebral artery) confirmed by neuro-imaging (CTA or MRA)\n- treatment with EVT, defined as groin puncture in the angio suite\n- CT or MRI ruling out intracranial hemorrhage\n- a pre-EVT score of at least 10 on the NIHSS\n- age of 18 years or older\n- written informed consent (deferred)\n- possibility to start trial treatment within 6 hours of stroke onset"}
Exclusion criteria
- {"criterion_text":"- pre-stroke disability defined as mRS ≥ 2\n- life expectancy shorter than one year\n- child-bearing potential"}
Endpoints
Primary endpoints
- {"endpoint_text":"- score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier","definition_or_measurement_approach":"NIHSS score measured at seven days (±1) after stroke onset or at discharge if earlier."}
Secondary endpoints
- {"endpoint_text":"- the score on the mRS at 90 days (±14) after stroke onset\n- the score on Barthel index at 90 days (±14) after stroke onset\n- mortality at 90 days (±14)\n- scores on the NIHSS at 24 (±6) and 72 (±12) hours after stroke onset\n- score on the telephone version of the Montreal Cognitive Assessment (t-MoCA) at 90 days (±14)\n- infarct size at 72 hours (±24) (based on MRI measurements)\n- blood glucose levels at days 1-7 (or until discharge)\n- blood pressure at days 1-7 (or until discharge)\n- body temperature at days 1-7 (or until discharge)\n- SAEs","definition_or_measurement_approach":"mRS at 90 days (±14 days); Barthel Index at 90 days (±14 days); mortality at 90 days (±14 days); NIHSS at 24 (±6) and 72 (±12) hours; t-MoCA at 90 days (±14); infarct size at ~72 hours based on MRI; daily measurements of blood glucose, blood pressure and body temperature on days 1-7 or until discharge; recording of serious adverse events (SAEs)."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 18
- Consent Approach
- Deferred written informed consent is used ("written informed consent (deferred)"). Subject information and ICF templates for deferred consent and legal representative ICFs are available (multiple L1 SIS and ICF documents listed). Consent is by the subject when possible or by a legal representative as provided in the legal representative ICFs.
Geography
- Total Number Of Sites
- 4
- Total Number Of Participants
- 80
Netherlands
- Earliest CTIS Part Ii Submission Date
- 01-10-2024
- Latest Decision Or Authorization Date
- 15-10-2024
- Processing Time Days
- 14
- Number Of Sites
- 4
- Number Of Participants
- 80
Sites
- Site Name
- Medisch Spectrum Twente
- Department Name
- Neurology
- Contact Person Name
- R.M. Arntz
- Contact Person Email
- Renate.Arntz@mst.nl
- Site Name
- Isala Klinieken Stichting
- Department Name
- Neurology
- Contact Person Name
- C.J.A.B Kersten
- Contact Person Email
- c.j.b.a.kersten@isala.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Neurology
- Contact Person Name
- H.B. van der Worp
- Contact Person Email
- h.b.vanderworp@umcutrecht.nl
- Site Name
- Rijnstate Ziekenhuis Stichting
- Department Name
- Neurology
- Contact Person Name
- Jeannette Hofmeijer
- Contact Person Email
- jhofmeijer@rijnstate.nl
Sponsor
Primary sponsor
- Full Name
- Rijnstate Ziekenhuis Stichting
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- Acyl-ghreline
- Active Substance
- LENOMORELIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Route
- Intravenous bolus injection/IV infusion
- Starting Dose
- 600 µg twice daily
- Dose Levels
- 600 µg twice daily for 5 days
- Frequency
- twice daily
- Maximum Dose
- 1200 µg per day; 6000 µg total
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