Stroke, IschemicPhase 2MR GENTLENCT05726240
RCT of Ghrelin in Stroke Patients
A Phase 2 study testing Ghrelin in people with Stroke, Ischemic, run by Rijnstate Hospital at 3 sites in Netherlands.
Trial summary
About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Ghrelin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2023to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
- treatment with EVT, defined as groin puncture in the angio suite,
- CT or MRI ruling out intracranial hemorrhage,
- a pre-EVT score of at least 10 on the NIHSS,
- age of 18 years or older,
- written informed consent (deferred).
Who cannot join
- pre-stroke disability defined as mRS ≥ 2,
- life expectancy shorter than one year,
- child-bearing potential.
Trial locations and contacts
3 sites in 1 country.
Daphne van der Veen, MSc contact
Netherlands3 sites
Medisch Spectrum Twente
Enschede
Renate Arntz, Renate.Arntz@mst.nl
Renate Arntz
University Medical Center Utrecht
Utrecht
Bart van der Worp, H.B.vanderWorp@umcutrecht.nl
Bart van der Worp
Isala
Zwolle
About this study
Official title: Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.
Read the detailed description
We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
- Conditions
- Stroke, Ischemic
- Being tested
- Ghrelin
- Keywords
- Endovascular thrombectomy, Ghrelin
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GhrelinDrug
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
| Study group | Role | What they receive |
|---|---|---|
| Ghrelin treatment | Experimental | Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated. Receives: Drug: Ghrelin |
| Standard care | No intervention | Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health Stroke Scale score
The primary outcome measure is the score on the National Institutes of Health Stroke Scale at seven days (±1) after stroke onset or at discharge, if earlier. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Measured: 7 days after stroke onset
Secondary outcomes (9)
Modified Rankin Scale score
The score on the Modified Rankin Scale at 90 days after stroke onset. The mRS is an ordinal hierarchical scale that describes disabilities encountered post stroke, incorporating six categories from 0 (complete recovery) up to and including 5 (severe disability). 'Death' is assigned a score of 6 .
Measured: 90 days after stroke onset
Mortality
Mortality at 90 days
Measured: 90 days after stroke onset
National Institutes of Health Stroke Scale score
Scores on National Institutes of Health Stroke Scale at 24 hours after stroke onset. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Measured: 24 hours after stroke onset
National Institutes of Health Stroke Scale score
Scores on National Institutes of Health Stroke Scale at 72 hours after stroke onset. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
Measured: 72 hours after stroke onset
Telephonic Montreal Cognitive Assessment
Score on the telephone version of the Montreal Cognitive Assessment at 90 days. The MoCA 5-minute protocol consists of 4 subtests examining 5 cognitive domains, including attention, verbal learning and memory, executive functions/language, and orientation. Total scores of the MoCA 5-minute protocol range between 0 and 30 with lower scores indicating a better cognition.
Measured: 90 days after stroke onset
Infarct size
Infarct size at 72 hours (based on Magnetic resonance imaging measurements)
Measured: 72 hours after stroke onset
Blood glucose levels
Blood glucose levels at days 1-7 (or until discharge)
Measured: Days 1-7 after stroke onset
Blood pressure
Blood pressure at days 1-7 (or until discharge)
Measured: Days 1-7 after stroke onset
Body temperature
Body temperature at days 1-7 (or until discharge)
Measured: Days 1-7 after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startOct 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a phase 2 multicenter clinical trial with random treatment allocation, open label treatment and blinded endpoint assessment (PROBE design). The intervention contrast will be intravenous acylated ghrelin in addition to standard care (intervention group) vs. standard care alone (control group).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726240
- Sponsor's protocol ID
- MR GENTLE
- Acronym
- MR GENTLE
- Status last verified
- Jul 2023
- First submitted
- 1 Feb 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Omes QPM, van der Veen D, Kersten CJBA, Arntz RM, Filius PMG, van den Wijngaard IR, van der Worp HB, Hofmeijer J. MR GENTLE-multicentre randomised controlled trial of ghrelin in anterior circulation ischaemic stroke treated with endovascular thrombectomy: a phase 2 trial. Trials. 2026 Jan 16;27(1):126. doi: 10.1186/s13063-026-09426-8.
PubMed 41546024
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Trial of Ghrelin in Anterior Circulation Ischemic Stroke Treated With Endovascular Thrombectomy. A Randomized Phase 2 Trial
- ClinicalTrials.gov ID
- NCT05726240
- Acronym / sponsor ID
- MR GENTLE / MR GENTLE
- Conditions
- Stroke, Ischemic
- Keywords
- Endovascular thrombectomy, Ghrelin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
About half of the patients with acute ischemic stroke treated with endovascular thrombectomy (EVT) remain dependent on the help of others or die in the first 90 days. We hypothesize that treatment with ghrelin, started in the first six hours after stroke onset, improves early recovery and long-term functional outcome in these patients. Ghrelin is a naturally occurring hormone and mildly excitatory neurotransmitter also known as the 'hunger hormone.' Treatment with acylated ghrelin consistently improved functional and histological recovery in in vitro and in vivo models of ischemic stroke.
Detailed description
We will include 80 patients with acute ischemic stroke caused by large vessel occlusion of the anterior circulation, eligible for EVT. The study population will be drawn from adult patients with acute ischemic stroke treated with EVT at UMC Utrecht, Rijnstate, MST or Isala.
Treatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a phase 2 multicenter clinical trial with random treatment allocation, open label treatment and blinded endpoint assessment (PROBE design). The intervention contrast will be intravenous acylated ghrelin in addition to standard care (intervention group) vs. standard care alone (control group).
| Arm | Type | Receives |
|---|---|---|
| Ghrelin treatment | Experimental | Drug: GhrelinTreatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated. |
| Standard care | No intervention | –Treatment in the standard group consists of local practices for the treatment of stroke, including intravenous thrombolysis, if indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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),
- treatment with EVT, defined as groin puncture in the angio suite,
- CT or MRI ruling out intracranial hemorrhage,
- a pre-EVT score of at least 10 on the NIHSS,
- age of 18 years or older,
Key exclusion criteria (3 listed)
- pre-stroke disability defined as mRS ≥ 2,
- life expectancy shorter than one year,
- child-bearing potential.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GhrelinTreatment in the intervention group will consist of intravenous acylated ghrelin, 600micrg dissolved in 50cc normal saline, by bolus (short term) infusion in 30 minutes, twice daily, for five days. This treatment will be additional to standard treatment, including intravenous thrombolysis, if indicated. | Drug | Ghrelin treatment |
Primary outcome
National Institutes of Health Stroke Scale score
Time frame: 7 days after stroke onset
The primary outcome measure is the score on the National Institutes of Health Stroke Scale at seven days (±1) after stroke onset or at discharge, if earlier. The NIHSS is a continuous scale to evaluate the severity of stroke by assessing a patient's performance. Scores range from 0 to 42, with higher scores indicating a more severe deficit.
9 secondary outcomes
Modified Rankin Scale score
Time frame: 90 days after stroke onset
Mortality
Time frame: 90 days after stroke onset
National Institutes of Health Stroke Scale score
Time frame: 24 hours after stroke onset
National Institutes of Health Stroke Scale score
Time frame: 72 hours after stroke onset
Telephonic Montreal Cognitive Assessment
Time frame: 90 days after stroke onset
Infarct size
Time frame: 72 hours after stroke onset
Blood glucose levels
Time frame: Days 1-7 after stroke onset
Blood pressure
Time frame: Days 1-7 after stroke onset
Body temperature
Time frame: Days 1-7 after stroke onset
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 41546024Omes QPM, van der Veen D, Kersten CJBA, Arntz RM, Filius PMG, van den Wijngaard IR, van der Worp HB, Hofmeijer J. MR GENTLE-multicentre randomised controlled trial of ghrelin in anterior circulation ischaemic stroke treated with endovascular thrombectomy: a phase 2 trial. Trials. 2026 Jan 16;27(1):126. doi: 10.1186/s13063-026-09426-8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daphne van der Veen, MSc contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ghrelin in people with Stroke, Ischemic, run by Rijnstate Hospital at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeannette Hofmeijer, MD, PhD (0880058877, jhofmeijer@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health Stroke Scale score (time frame: 7 days after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.