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Loss of Financial Sponsor
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| Name | Class |
|---|---|
| Nico Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIPS + Pioglitazone | Experimental | 20 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hematoma Clearance on CT During Hospitalization | Number of participants demonstrating hematoma clearance on serial CT imaging during hospitalization. | up to 7 Days |
| Safety: Number of Participants With 30-day Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21201 | United States |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Due to a cut in study funding, this trial closed prior to reaching its expected target. Therefore only 1 patient was enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Participants | 180 Days |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Unitveristy of Maryland,Baltimore | 410-328-0939 | Khenry@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2022 | Feb 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 14, 2023 | Feb 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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.
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|
30-day mortality (30 days from intervention)
| 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. | 24 Hours |
| Safety: Number of Participants With Bacterial Brain Infection | 30-day bacterial brain infection (30 days from intervention) | 30 Days |
| Safety: Number of Participants With Hypoglycemia | Occurrences of Moderate hypoglycemia (<70 mg/dL) or Severe hypoglycemia (<50 mg/dL) requiring rescue therapy | Up to 180 days (assessed at 30, 90, 120, and 180 days) |
| Safety: Number of Participants With Drug Toxicity | evidence of drug-induced toxicities | 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. | Up to 180 days |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Hematoma Clearance on CT During Hospitalization | Number of participants demonstrating hematoma clearance on serial CT imaging during hospitalization. | 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. | Posted | Count of Participants | Participants | up to 7 Days |
|
|
|
| Secondary | Safety: Number of Participants With 30-day Mortality | 30-day mortality (30 days from intervention) | 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. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 24 Hours |
|
|
|
| Secondary | Safety: Number of Participants With Bacterial Brain Infection | 30-day bacterial brain infection (30 days from intervention) | 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. | Posted | Count of Participants | Participants | 30 Days |
|
|
|
| Secondary | Safety: Number of Participants With Hypoglycemia | Occurrences of Moderate hypoglycemia (<70 mg/dL) or Severe hypoglycemia (<50 mg/dL) requiring rescue therapy | 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. | Posted | Count of Participants | Participants | Up to 180 days (assessed at 30, 90, 120, and 180 days) |
|
|
|
| Secondary | Safety: Number of Participants With Drug Toxicity | evidence of drug-induced toxicities | 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. | Posted | Count of Participants | Participants | up to 180 days |
|
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | QALY | Up to 180 days |
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|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |