Intracerebral Haemorrhage, IntraventricularPhase 2ENRICHPLUSNCT05582707

Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone

A Phase 2 study testing Pioglitazone 15mg in people with Intracerebral Haemorrhage, Intraventricular, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is an exploratory single-center prospective study of 20 subjects with primary basal ganglia ICH who will receive early MIPS in combination with perioperative pioglitazone treatment. Outcomes will be compared to matched subjects with basal ganglia ICH who undergo MIPS alone as part of the ENRICH trial. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Intracerebral Haemorrhage, Intraventricular
What is being tested?: Pioglitazone 15mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: 8 May 2023to 25 Dec 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80 years
CT scan demonstrating an acute, spontaneous, primary basal ganglia ICH
ICH volume between 30 - 80 mL as calculated by the ABC/2 method
Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. In situations with unclear time of onset, then the onset will be considered the time that the subject was last known to be well
Glasgow Coma Score (GCS) 5 - 14
Historical Modified Rankin Score 0 or 1
Consent by patient or LAR to MIS evacuation of the ICH based on best medical practice1
Time to pioglitazone treatment ≤ 24 hours from symptom onset or TLKN1

Who cannot join

Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, hemorrhagic conversion of an ischemic infarct, or bleeding into a known neoplastic lesion
NIHSS< 5, bilateral fixed dilated pupils, extensor motor posturing, unstable mass or evolving intracranial compartment syndrome
Intraventricular extension of the hemorrhage estimated to involve >50% of either of the lateral ventricles (External ventricular drain (EVD) to treat intracranial pressure (ICP) or hydrocephalus is allowed)
Primary thalamic ICH or infratentorial intraparenchymal hemorrhage including midbrain, pons or cerebellum
Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site
Severe kidney or liver disease (serum ALT > 2.5 x ULN) with active coagulopathy

Show all 21Show fewer

Patients requiring long-term anticoagulation that needs to be initiated < 5 days from index ICH; patient must not require Coumadin (anticoagulation) during the first 30 days (reversal of anticoagulation is permitted for medically stable patients who can safely tolerate the short-term risk of reversal)
Use of anticoagulants that cannot be rapidly reversed, uncorrected coagulopathy or known clotting disorder
Platelet count < 75,000
International Normalized Ratio (INR) > 1.4 after correction or inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as, but not limited to, NovoSeven, fresh frozen plasma, vitamin K, Kcentra or Feiba)
Untreatable elevated activated partial thromboplastin time (aPTT)
Patients with a mechanical heart valve (presence of bioprosthetic valve(s) is permitted)
Positive urine or serum pregnancy test in female subjects without documented history of surgical sterilization or is post-menopausal
Participation in a concurrent interventional medical investigation or clinical trial
Known life-expectancy of less than 6 months, no reasonable expectation of recovery, Do-Not-Resuscitate (DNR), or comfort measures only prior to randomization
Inability or unwillingness of subject or legal guardian/representative to give written informed consent
Homelessness or history of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
intolerance or allergy to any TZD1
T2DM treated with insulin or an oral medication including Glyburide, unless the NICU physician deems it safe to replace the T2DM medication with pioglitazone1
heart failure (symptomatic or NYHA Class I-IV or newly diagnosed on admission TTE screening)
patients with abnormal (>1x upper limit of normal) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland, Baltimore
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Non-Randomized Controlled Trial to Examine the Safety and Suitability of Supplementing Early Minimally Invasive Parafascicular Surgery (MIPS) for Clot Evacuation of Basal Ganglia Intracerebral Hemorrhage (ICH) With Pioglitazone

Read the detailed description

Study Arms:

Group 1: 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks

Group 2: Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device as part of the ENRICH trial (NCT02880878). These subjects will be enrolled at an ENRICH trial site independent of our Institution. Deidentified patient information from 20 subjects in this group, who will be matched to those in the ENRICH-PLUS group, will be provided to the principal investigator for comparison of outcomes.

Consent for study participation will be obtained from the patient or the LAR only after fulfilling all inclusion and exclusion criteria either before or after MIPS, which will be scheduled as a standard institutional procedure outside the realm of the study.

Study participants will be administered pioglitazone (15 mg tablet) either p.o. or enteral (via nasogastric tube). The first dose may be administered prior to surgery or within 3 hours of the end of surgery but must be administered within 24 hours of the index event or time last known normal (TLKN). Pioglitazone (15 mg tablet) administration will continue 3 times daily for 3 weeks, including after hospital discharge, if applicable.

Following completion of pioglitazone, subjects will be followed at days 30, 90, 120 and 180 post MIPS. In addition to AE monitoring during these follow up's, a utility-weighted mRS (uw-mRS) at 180 days will serve as the primary end point.

Conditions: Intracerebral Haemorrhage, Intraventricular
Being tested: Pioglitazone 15mg
Keywords: Pioglitazone, Basal Ganglia Intracerebral Hemorrhage (ICH), Minimally Invasive Parafascicular Surgery
Medical subject headings: Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pioglitazone 15mgDrug
Study participants will be administered pioglitazone (15 mg tablet) either p.o. or enteral (via nasogastric tube). The first dose may be administered prior to surgery or within 3 hours of the end of surgery but must be administered within 24 hours of the index event or time last known normal (TLKN). Pioglitazone (15 mg tablet) administration will continue 3 times daily for 3 weeks, including after hospital discharge, if applicable.

Study groups in NCT05582707
Study group	Role	What they receive
MIPS + Pioglitazone	Experimental	20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Receives: Drug: Pioglitazone 15mg
MIPS Alone	No intervention	This trial will compare it's subjects to subjects who have previously undergone MIPS for evacuation of ICH using the BrainPath access device as part of the ENRICH trial (NCT02880878). These subjects will be enrolled at an ENRICH trial site independent of our Institution. Deidentified patient information from 20 subjects in this group, who will be matched to those in the ENRICH-PLUS group, will be provided to the principal investigator for comparison of outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Improvement - Modified Rankin Scale (mRS)
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180 days. This is a scale from 0 to 6, where 0 is the best score (no symptoms) and 6 is the worst score.
Measured: 180 Days

Secondary outcomes (7)

Hematoma Clearance on CT During Hospitalization
Number of participants demonstrating hematoma clearance on serial CT imaging during hospitalization.
Measured: up to 7 Days
Safety: Number of Participants With 30-day Mortality
30-day mortality (30 days from intervention)
Measured: 30 days
Number of Participants With an Increase in Hemorrhage Volume Between Index CT and 24-Hour Follow-up CT
Number of participants with an increase in hemorrhage volume between the index CT scan and the 24-hour follow-up CT scan.
Measured: 24 Hours
Safety: Number of Participants With Bacterial Brain Infection
30-day bacterial brain infection (30 days from intervention)
Measured: 30 Days
Safety: Number of Participants With Hypoglycemia
Occurrences of Moderate hypoglycemia (<70 mg/dL) or Severe hypoglycemia (<50 mg/dL) requiring rescue therapy
Measured: Up to 180 days (assessed at 30, 90, 120, and 180 days)
Safety: Number of Participants With Drug Toxicity
evidence of drug-induced toxicities
Measured: up to 180 days
Quality-Adjusted Life Years (QALY)
Quality-adjusted life years (QALY) were calculated as the product of duration of life and quality of life. QALY values range from 0 (death) to 1 (perfect health), with higher values indicating better health status.
Measured: Up to 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 May 202325 Dec 2025

First posted17 Oct 2022
Study start8 May 2023
Primary completion19 Sep 2024
Study completion25 Dec 2025

Why it stopped: Loss of Financial Sponsor

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Intracerebral Haemorrhage, IntraventricularStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Single group
Model description: All subjects enrolled in this trial will be in the Experimental arm and receive intervention of MIPS + Pioglitazone. These patients will be compared to a dataset of subjects who have already undergone MIPS alone in a previous trial.
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05582707
Sponsor's protocol ID: HP-00102344
Acronym: ENRICHPLUS
Status last verified: Apr 2026
First submitted: 3 Oct 2022
Last updated: 28 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Intracerebral Haemorrhage, Intraventricular trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Non-Randomized Controlled Trial to Examine the Safety and Suitability of Supplementing Early Minimally Invasive Parafascicular Surgery (MIPS) for Clot Evacuation of Basal Ganglia Intracerebral Hemorrhage (ICH) With Pioglitazone
ClinicalTrials.gov ID: NCT05582707
Acronym / sponsor ID: ENRICHPLUS / HP-00102344
Conditions: Intracerebral Haemorrhage, Intraventricular
Keywords: Pioglitazone, Basal Ganglia Intracerebral Hemorrhage (ICH), Minimally Invasive Parafascicular Surgery
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Loss of Financial Sponsor
Enrolment: 1 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Collaborators: Nico Corporation
Study start: 8 May 2023 (actual)
Primary completion: 19 Sep 2024 (actual)
Study completion: 25 Dec 2025 (actual)
First posted: 17 Oct 2022 (actual)
Results: Posted 28 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Arms:

Group 1: 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: All subjects enrolled in this trial will be in the Experimental arm and receive intervention of MIPS + Pioglitazone. These patients will be compared to a dataset of subjects who have already undergone MIPS alone in a previous trial.

Arm	Type	Receives
MIPS + Pioglitazone	Experimental	Drug: Pioglitazone 15mg20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks
MIPS Alone	No intervention	–This trial will compare it's subjects to subjects who have previously undergone MIPS for evacuation of ICH using the BrainPath access device as part of the ENRICH trial (NCT02880878). These subjects will be enrolled at an ENRICH trial site independent of our Institution. Deidentified patient information from 20 subjects in this group, who will be matched to those in the ENRICH-PLUS group, will be provided to the principal investigator for comparison of outcomes.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age 18-80 years
CT scan demonstrating an acute, spontaneous, primary basal ganglia ICH
ICH volume between 30 - 80 mL as calculated by the ABC/2 method
Study intervention can reasonably be initiated within 24 hours after the onset of stroke symptoms. In situations with unclear time of onset, then the onset will be considered the time that the subject was last known to be well
Glasgow Coma Score (GCS) 5 - 14

Key exclusion criteria (21 listed)

Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, hemorrhagic conversion of an ischemic infarct, or bleeding into a known neoplastic lesion
NIHSS< 5, bilateral fixed dilated pupils, extensor motor posturing, unstable mass or evolving intracranial compartment syndrome
Intraventricular extension of the hemorrhage estimated to involve >50% of either of the lateral ventricles (External ventricular drain (EVD) to treat intracranial pressure (ICP) or hydrocephalus is allowed)
Primary thalamic ICH or infratentorial intraparenchymal hemorrhage including midbrain, pons or cerebellum
Evidence of active bleeding involving a retroperitoneal, gastrointestinal, genitourinary, or respiratory tract site

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
Pioglitazone 15mgStudy participants will be administered pioglitazone (15 mg tablet) either p.o. or enteral (via nasogastric tube). The first dose may be administered prior to surgery or within 3 hours of the end of surgery but must be administered within 24 hours of the index event or time last known normal (TLKN). Pioglitazone (15 mg tablet) administration will continue 3 times daily for 3 weeks, including after hospital discharge, if applicable.	Drug	MIPS + Pioglitazone

Primary outcome

Functional Improvement - Modified Rankin Scale (mRS)
Time frame: 180 Days
Functional Improvement as determined by utility-weighted modified Rankin Scale (mRS) at 180 days. This is a scale from 0 to 6, where 0 is the best score (no symptoms) and 6 is the worst score.

7 secondary outcomes

Hematoma Clearance on CT During Hospitalization
Time frame: up to 7 Days
Safety: Number of Participants With 30-day Mortality
Time frame: 30 days
Number of Participants With an Increase in Hemorrhage Volume Between Index CT and 24-Hour Follow-up CT
Time frame: 24 Hours
Safety: Number of Participants With Bacterial Brain Infection
Time frame: 30 Days
Safety: Number of Participants With Hypoglycemia
Time frame: Up to 180 days (assessed at 30, 90, 120, and 180 days)
Safety: Number of Participants With Drug Toxicity
Time frame: up to 180 days
Quality-Adjusted Life Years (QALY)
Time frame: Up to 180 days

Results and safety

Results posted to the registry on 28 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MIPS + Pioglitazone	1	1
MIPS Alone	0	0

Primary outcome: Functional Improvement - Modified Rankin Scale (mRS)

Time frame: 180 Days. Number. Unit: Participants

Measure	MIPS + Pioglitazone n = 1	MIPS Alone n = 0
mRS = 0	0	–
mRS = 1	0	–
mRS = 2	0	–
mRS = 3	1	–
mRS = 4	0	–
mRS = 5	0	–
mRS = 6	0	–

Population analysed: One participant was enrolled in the MIPS + Pioglitazone arm and completed the 180-day follow-up assessment of functional status using the modified Rankin Scale (mRS). No participants were enrolled in the MIPS Alone arm. Results are descriptive for the single treated participant.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events will be reported from the fine of first initial administration of pioglitazone through the conclusion of the 180 Day follow up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIPS + Pioglitazone	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MIPS Alone	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): The study closed prematurely due to the sponsor company's acquisition, which led to early termination of enrollment. Although the single enrolled participant completed the study period, an N=1 provides insufficient data to achieve the statistical power originally planned or to meaningfully evaluate the study's prespecified endpoints.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone 15mg in people with Intracerebral Haemorrhage, Intraventricular, run by University of Maryland, Baltimore at 1 site in United States.

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 8 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Improvement - Modified Rankin Scale (mRS) (time frame: 180 Days). 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 NCT05582707.

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 28 Apr 2026.