Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Aneurysm Hemorrhage
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Minocycline
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Aneurysm Hemorrhage focused on measuring SAH
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 yrs of age
- Ruptured aneurysm
- Initiate treatment within 72 hours of SAH
- Pre Rankin ≤ 1
Exclusion Criteria:
- Hunt & Hess 5 with no improvement
- ICP > 30
- No plans to treat aneurysm
- Allergy to Tetracycline / Antibiotics
- Creatinine >2
- Platelets < 75,000
- Other brain diseases
- Previous infection requiring Tetracycline
Sites / Locations
- University of Buffalo Neurosurgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Minocycline
Placebo
Arm Description
200 mg IV/placebo Followed by 100 mg IV BID x 7days Followed by 200 mg tablet QD x 14days
200 mg IV/placebo
Outcomes
Primary Outcome Measures
adverse event
The primary objective of the study is to evaluate the effectiveness of minocycline in improving outcomes for patients after aneurysmal SAH.
To determine the safety of minocycline 200mg/day for 21 days in the treatment arm after aneurysmal subarachnoid hemorrhage.
Secondary Outcome Measures
comparative stroke scale
To demonstrate a significant difference in outcome at 3 months as measured by NIHSS, mRS, BI and GOS in the minocycline treatment group when compared to the placebo arm.
To determine any significant differences in vasospasm rates, duration of vasospasm, interventions for vasospasm, vasospasm related infarcts and delayed ischemic deficits between minocycline and placebo arms
Full Information
NCT ID
NCT02113176
First Posted
January 31, 2014
Last Updated
May 17, 2022
Sponsor
University at Buffalo
Collaborators
University at Buffalo Neurosurgery
1. Study Identification
Unique Protocol Identification Number
NCT02113176
Brief Title
Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Funding of minocycline
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
University at Buffalo Neurosurgery
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of a drug minocycline in improving outcomes at 3 months after rupture of an aneurysm in the head.
Detailed Description
Prior to the drug:
If you decide to take part in this study, you will have a brief interview about your medical history and any medications you are taking. You will have a medical and neurological examination, CT scan and/or an angiogram to look at the blood vessel and blood supply going to the brain, and blood samples drawn for a complete blood count, chemistry analysis and cardiac enzymes (to assess any recent damage to your heart). You will have a surgery or an image guided procedure to close your aneurysm.
Additionally, during the course of the study you may be asked to have a computerized tomography (CT scan) or magnetic resonance imaging (MRI) if there is a necessity. These tests will reveal areas that might have been damaged in your brain.
Drug:
If the tests show that you qualify as a candidate for this study, you will be randomly assigned (like a flip of a coin) to have either the minocycline drug or a dummy drug that looks the same but does not have the drug in it. For the first 7 days, the drug will be given as an injection two times a day and after that for 14 days once a day by mouth. Rest of the care will be standard like in any aneurysm patient. We study the status of your blood vessel surrounding the brain with ultrasound daily to see if they have any narrowing. If the doctors find any narrowing, you will be treated to relive the narrowing. If you are discharged home at any point in the 21 days, you will be switch the oral drug and given the required drugs with instructions.
Follow up:
Before you are discharged from the hospital and at 7, 21, 30 and 90 days after the start of the drug, the following evaluations will be performed: a complete physical and neurological examinations.
As part of this study, you are required to return to the hospital or to your physician at one (1), seven (7), twenty-one (21), thirty (30), ninety (90) days after stroke onset. You will have a physical exam, a complete neurological exam. Additionally, you will be asked questions about any health problems or hospitalizations you have had since you were discharged from the hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Aneurysm Hemorrhage
Keywords
SAH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minocycline
Arm Type
Experimental
Arm Description
200 mg IV/placebo
Followed by 100 mg IV BID x 7days
Followed by 200 mg tablet QD x 14days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
200 mg IV/placebo
Intervention Type
Drug
Intervention Name(s)
Minocycline
Primary Outcome Measure Information:
Title
adverse event
Description
The primary objective of the study is to evaluate the effectiveness of minocycline in improving outcomes for patients after aneurysmal SAH.
To determine the safety of minocycline 200mg/day for 21 days in the treatment arm after aneurysmal subarachnoid hemorrhage.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
comparative stroke scale
Description
To demonstrate a significant difference in outcome at 3 months as measured by NIHSS, mRS, BI and GOS in the minocycline treatment group when compared to the placebo arm.
To determine any significant differences in vasospasm rates, duration of vasospasm, interventions for vasospasm, vasospasm related infarcts and delayed ischemic deficits between minocycline and placebo arms
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 18 yrs of age
Ruptured aneurysm
Initiate treatment within 72 hours of SAH
Pre Rankin ≤ 1
Exclusion Criteria:
Hunt & Hess 5 with no improvement
ICP > 30
No plans to treat aneurysm
Allergy to Tetracycline / Antibiotics
Creatinine >2
Platelets < 75,000
Other brain diseases
Previous infection requiring Tetracycline
Facility Information:
Facility Name
University of Buffalo Neurosurgery
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
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