Multicentre Randomized trial of Ghrelin in anterior circulation ischemic stroke treated with endovascular thrombectomy. A randomized phase 2 trial.

2024-515705-26-00 Therapeutic exploratory (Phase II) Ongoing, recruiting

Start 11 Nov 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 4 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruiting
Participants planned 80
Countries 1
Sites 4

Stroke

The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation and treated with EVT.

Key facts

Sponsor
Rijnstate Ziekenhuis Stichting
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nervous System Diseases [C10], Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
11 Nov 2024 → ongoing
Decision date (initial)
2024-10-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Dutch Heart Foundation · Rijnstate Vriendenfonds

External identifiers

EU CT number
2024-515705-26-00
EudraCT number
2022-001632-28
ClinicalTrials.gov
NCT05726240

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective of this study is to assess the effect of ghrelin on the severity of the neurological deficit at seven days after symptom onset in patients with acute ischemic stroke
caused by large vessel occlusion of the anterior circulation and treated with EVT.

Secondary objectives 8

  1. Effects of ghrelin on functional outcome at 90 days
  2. Effects of ghrelin on neurological deficit at one and three days after symptom onset
  3. Effects of ghrelin on infarct size at day 3 +/- 1
  4. Effects of ghrelin on blood glucose levels at day 1-7
  5. Effects of ghrelin on blood pressure at day 1-7
  6. Effects of ghrelin on temperature at day 1-7
  7. Effects of ghrelin on safety (numer of SAEs; mortality)
  8. Effects of ghrelin on cognitive functioning at 90 days (expressed as the score on the telephone version of the Montreal Cognitive Assessment (t-MoCA)

Conditions and MedDRA coding

Stroke

VersionLevelCodeTermSystem organ class
22.1 LLT 10055221 Ischemic stroke 10029205

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

  1. 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)
  2. treatment with EVT, defined as groin puncture in the angio suite
  3. CT or MRI ruling out intracranial hemorrhage
  4. a pre-EVT score of at least 10 on the NIHSS
  5. age of 18 years or older
  6. written informed consent (deferred)
  7. possibility to start trial treatment within 6 hours of stroke onset

Exclusion criteria 3

  1. pre-stroke disability defined as mRS ≥ 2
  2. life expectancy shorter than one year
  3. child-bearing potential

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. score on the NIHSS at seven days (±1) after stroke onset or at discharge, if earlier

Secondary endpoints 10

  1. the score on the mRS at 90 days (±14) after stroke onset
  2. the score on Barthel index at 90 days (±14) after stroke onset
  3. mortality at 90 days (±14)
  4. scores on the NIHSS at 24 (±6) and 72 (±12) hours after stroke onset
  5. score on the telephone version of the Montreal Cognitive Assessment (t-MoCA) at 90 days (±14)
  6. infarct size at 72 hours (±24) (based on MRI measurements)
  7. blood glucose levels at days 1-7 (or until discharge)
  8. blood pressure at days 1-7 (or until discharge)
  9. body temperature at days 1-7 (or until discharge)
  10. SAEs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Acyl-ghreline

PRD11564776 · Product

Active substance
Lenomorelin
Substance synonyms
GHRELIN, ACYL-GHRELIN, SUN11031
Pharmaceutical form
LYOPHILISATE FOR SUSPENSION FOR INJECTION
Route of administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose
1200 µg microgram(s)
Max total dose
6000 µg microgram(s)
Max treatment duration
5 Day(s)
Authorisation status
Not Authorised
MA holder
STICHTING RIJNSTATE ZIEKENHUIS
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rijnstate Ziekenhuis Stichting

2 Total trials 1 Recruiting
Academic / Non-commercial
Sponsor organisation
Rijnstate Ziekenhuis Stichting
Address
Wagnerlaan 55
City
Arnhem
Postcode
6815 AD
Country
Netherlands

Scientific contact point

Organisation
Rijnstate Ziekenhuis Stichting
Contact name
Prof. dr. J. Hofmeijer

Public contact point

Organisation
Rijnstate Ziekenhuis Stichting
Contact name
Prof. dr. J. Hofmeijer

Locations

1 EU/EEA country · 4 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Ongoing, recruiting 80 4
Rest of world — 0 —

Investigational sites

Netherlands

4 sites · Ongoing, recruiting
Rijnstate Ziekenhuis Stichting
Neurology, Wagnerlaan 55, 6815 AD, Arnhem
Medisch Spectrum Twente
Neurology, Koningsplein 1, 7512 KZ, Enschede
Universitair Medisch Centrum Utrecht
Neurology, Heidelberglaan 100, 3584 CX, Utrecht
Isala Klinieken Stichting
Neurology, Dokter Van Heesweg 2, 8025 AB, Zwolle

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Netherlands 2024-11-11 2024-11-22

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1 protocol 2024-515705-26-00 1.4
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_for publication 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_for publication_RFI-CT-2024-515705-26-00-IN-001-02 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_not for publication 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_not for publication_RFI-CT-2024-515705-26-00-IN-001-02 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF legal representative_not for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_for publication 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_for publication_RFI-CT-2024-515705-26-00-IN-001-02 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_not for publication 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_not for publication_RFI-CT-2024-515705-26-00-IN-001-02 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient 2nd instance_not for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent version_not for publ_RFI-CT-2024-515705-26-00-IN-001-02 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent version_not for publ_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent_for publication 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent_for publication_RFI-CT-2024-515705-26-00-IN-001-02 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent_for publication_RFI-CT-2024-515705-26-00-IN-001-02_TC 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF patient deferred consent_not for publication 1.3
Synopsis of the protocol (for publication) D1_Protocol_synopsis_Dutch 2024-515705-26-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-17 Netherlands Acceptable with conditions
2024-10-15
 2024-10-15
2 SUBSTANTIAL MODIFICATION SM-1 2025-09-23 Netherlands Acceptable
2025-12-11
 2025-12-11

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