Trial Outcomes & Findings for Safety and Suitability of Supplementing Early MIP Surgery (MIPS) of ICH With Pioglitazone (NCT NCT05582707)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

180 Days

Results posted on

2026-04-28

Participant Flow

Recruitment was open for this trial from May 8, 2023 - Sept 19th, 2024 during which time we enrolled only one subject. Recruitment was closed due to sponsor companys aquisition, leading to loss of study funding prompting closure.

No significant pre-assignment events occurred. All participants who were enrolled (n=1) proceeded directly to study assignment without any washout, run-in period, or exclusion prior to group allocation.

Participant milestones

Participant milestones
Measure	MIPS + Pioglitazone 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=1 Participants	0 Participants	1 Participants n=1 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Age, Continuous	42 years n=1 Participants	—	42 years n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	0 Participants	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	0 Participants	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: 180 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Functional Improvement - Modified Rankin Scale (mRS) mRS = 0	0 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 1	0 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 2	0 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 3	1 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 4	0 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 5	0 Participants	—
Functional Improvement - Modified Rankin Scale (mRS) mRS = 6	0 Participants	—

SECONDARY outcome

Timeframe: up to 7 Days

Population: One participant was enrolled in the MIPS + Pioglitazone arm and underwent serial CT imaging during hospitalization for assessment of hematoma clearance. No participants were enrolled in the MIPS Alone arm. Results are descriptive for the single treated participant.

Number of participants demonstrating hematoma clearance on serial CT imaging during hospitalization.

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Hematoma Clearance on CT During Hospitalization Clearance observed	1 Participants	0 Participants
Hematoma Clearance on CT During Hospitalization No clearance observed	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: One participant was enrolled in the MIPS + Pioglitazone arm and was evaluated for 30-day mortality. No participants were enrolled in the MIPS Alone arm. Results are descriptive.

30-day mortality (30 days from intervention)

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Safety: Number of Participants With 30-day Mortality Alive at 30 days	1 Participants	0 Participants
Safety: Number of Participants With 30-day Mortality Dead at 30 days	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 Hours

Population: One participant was enrolled in the MIPS + Pioglitazone arm and underwent baseline and 24-hour follow-up CT imaging. No participants were enrolled in the MIPS Alone arm. Results are descriptive.

Number of participants with an increase in hemorrhage volume between the index CT scan and the 24-hour follow-up CT scan.

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Number of Participants With an Increase in Hemorrhage Volume Between Index CT and 24-Hour Follow-up CT Participants with increased hemorrhage volume	0 Participants	0 Participants
Number of Participants With an Increase in Hemorrhage Volume Between Index CT and 24-Hour Follow-up CT Participants without increased hemorrhage volume	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: One participant was enrolled in the MIPS + Pioglitazone arm and was evaluated for bacterial brain infection within 30 days. No participants were enrolled in the MIPS Alone arm. Results are descriptive.

30-day bacterial brain infection (30 days from intervention)

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Safety: Number of Participants With Bacterial Brain Infection Participants with bacterial brain infection	0 Participants	0 Participants
Safety: Number of Participants With Bacterial Brain Infection Participants without bacterial brain infection	1 Participants	0 Participants

SECONDARY outcome

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

Population: One participant was enrolled in the MIPS + Pioglitazone arm and was assessed for hypoglycemia through 180 days. No participants were enrolled in the MIPS Alone arm. No hypoglycemic events were observed.

Occurrences of Moderate hypoglycemia (\<70 mg/dL) or Severe hypoglycemia (\<50 mg/dL) requiring rescue therapy

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Safety: Number of Participants With Hypoglycemia Participants with hypoglycemia	0 Participants	0 Participants
Safety: Number of Participants With Hypoglycemia Participants without hypoglycemia	1 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 180 days

Population: One participant was enrolled in the MIPS + Pioglitazone arm and was assessed for drug-related toxicity through 180 days. No participants were enrolled in the MIPS Alone arm. No drug toxicities were observed.

evidence of drug-induced toxicities

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Safety: Number of Participants With Drug Toxicity Participants with drug toxicity	0 Participants	0 Participants
Safety: Number of Participants With Drug Toxicity Participants without drug toxicity	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 180 days

Population: One participant was enrolled in the MIPS + Pioglitazone arm and contributed data for QALY calculation through 180 days. No participants were enrolled in the MIPS Alone arm. With n=1, Results are descriptive.

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.

Outcome measures

Outcome measures
Measure	MIPS + Pioglitazone n=1 Participants 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Quality-Adjusted Life Years (QALY)	.32 QALY Standard Deviation 0	—

Adverse Events

MIPS + Pioglitazone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MIPS Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MIPS + Pioglitazone n=1 participants at risk 20 Subjects will undergo MIPS for evacuation of ICH using the BrainPath access device plus perioperative pioglitazone for 3 weeks Pioglitazone 15mg: 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 Alone 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.
Nervous system disorders Headache	100.0% 1/1 • Adverse Events will be reported from the fine of first initial administration of pioglitazone through the conclusion of the 180 Day follow up. The NCI CTCAE, Version 4.0, will be used for grading	— 0/0 • Adverse Events will be reported from the fine of first initial administration of pioglitazone through the conclusion of the 180 Day follow up. The NCI CTCAE, Version 4.0, will be used for grading

Additional Information

Clinical Research Manager

Unitveristy of Maryland,Baltimore

Phone: 410-328-0939

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place