Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

Sponsor

University at Buffalo (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02113176

Collaborator

University at Buffalo Neurosurgery (Other)

Enrollment

Location

Arms

107

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Aneurysm Hemorrhage	Drug: Minocycline	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Minocycline 200 mg IV/placebo Followed by 100 mg IV BID x 7days Followed by 200 mg tablet QD x 14days	Drug: Minocycline
Placebo Comparator: Placebo 200 mg IV/placebo	Drug: Minocycline

Arm

Intervention/Treatment

Experimental: Minocycline

200 mg IV/placebo Followed by 100 mg IV BID x 7days Followed by 200 mg tablet QD x 14days

Drug: Minocycline

Placebo Comparator: Placebo

200 mg IV/placebo

Drug: Minocycline

Outcome Measures

Primary Outcome Measures

adverse event [21 days]
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 [3 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Buffalo Neurosurgery	Buffalo	New York	United States	14203

Sponsors and Collaborators

University at Buffalo
University at Buffalo Neurosurgery

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adnan H. Siddiqui, Associate Professor of Neurosurgery & Radiology, Director of Neurosurgical Research, Director of Stroke Service, University at Buffalo

ClinicalTrials.gov Identifier:

NCT02113176

Other Study ID Numbers:

MINO-SAH

First Posted:

Apr 14, 2014

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Keywords provided by Adnan H. Siddiqui, Associate Professor of Neurosurgery & Radiology, Director of Neurosurgical Research, Director of Stroke Service, University at Buffalo

SAH

Additional relevant MeSH terms:

Aneurysm

Hemorrhage

Minocycline

Study Results

No Results Posted as of May 24, 2022