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

NCT05582707 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HP-00102344
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. This study will take approximately two years to complete.

Conditions

Intracerebral Haemorrhage, Intraventricular

Keywords

Pioglitazone; Basal Ganglia Intracerebral Hemorrhage (ICH); Minimally Invasive Parafascicular Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  180 Days

Secondary Outcomes (7)

• Hematoma Clearance on CT During Hospitalization

  up to 7 Days

• Safety: Number of Participants With 30-day Mortality

  30 days

• Number of Participants With an Increase in Hemorrhage Volume Between Index CT and 24-Hour Follow-up CT

  24 Hours

• Safety: Number of Participants With Bacterial Brain Infection

  30 Days

• Safety: Number of Participants With Hypoglycemia

  Up to 180 days (assessed at 30, 90, 120, and 180 days)

Study Arms (2)

MIPS + Pioglitazone

EXPERIMENTAL

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

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.

Interventions

Pioglitazone 15mg DRUG

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.

MIPS + Pioglitazone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Nico Corporation: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Unitveristy of Maryland,Baltimore

Khenry@som.umaryland.edu

410-328-0939

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 17, 2022
• Study Start: May 8, 2023
• Primary Completion: September 19, 2024
• Study Completion: December 25, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Locations

US (1)