Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage

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.

Study Overview

• Status: Withdrawn
• Conditions: Subarachnoid Aneurysm Hemorrhage
• Intervention / Treatment: Drug: Minocycline

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: University at Buffalo Neurosurgery

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: January 31, 2014
• First Submitted That Met QC Criteria: April 9, 2014
• First Posted (ESTIMATE): April 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: SAH
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Aneurysm; Anti-Infective Agents; Anti-Bacterial Agents; Minocycline
• Other Study ID Numbers: MINO-SAH