Subarachnoid Aneurysm HemorrhagePhase 1/2NCT02113176
Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
A Phase 1/2 study testing Minocycline in people with Subarachnoid Aneurysm Hemorrhage, run by University at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Aneurysm Hemorrhage
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 yrs of age
- Ruptured aneurysm
- Initiate treatment within 72 hours of SAH
- Pre Rankin ≤ 1
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Buffalo Neurosurgery
Buffalo, New York, 14203
About this study
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.
Read the 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.
- Conditions
- Subarachnoid Aneurysm Hemorrhage
- Being tested
- Minocycline
- Keywords
- SAH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | * 200 mg IV/placebo
* Followed by 100 mg IV BID x 7days
* Followed by 200 mg tablet QD x 14days Receives: Drug: Minocycline |
| Placebo | Placebo comparator | 200 mg IV/placebo Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2016 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Funding of minocycline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Aneurysm HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo Neurosurgery
- Responsible party
- Principal investigator, Adnan H. Siddiqui, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113176
- Sponsor's protocol ID
- MINO-SAH
- Status last verified
- Jul 2025
- First submitted
- 31 Jan 2014
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline as Neuroprotectant After Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02113176
- Acronym / sponsor ID
- MINO-SAH
- Conditions
- Subarachnoid Aneurysm Hemorrhage
- Keywords
- SAH
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding of minocycline
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University at BuffaloUniversity, hospital or other
- Collaborators
- University at Buffalo Neurosurgery
- Study start
- Jan 2010
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: Minocycline* 200 mg IV/placebo * Followed by 100 mg IV BID x 7days * Followed by 200 mg tablet QD x 14days |
| Placebo | Placebo comparator | Drug: Minocycline200 mg IV/placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 yrs of age
- Ruptured aneurysm
- Initiate treatment within 72 hours of SAH
- Pre Rankin ≤ 1
Key exclusion criteria (8 listed)
- Hunt \& Hess 5 with no improvement
- ICP > 30
- No plans to treat aneurysm
- Allergy to Tetracycline / Antibiotics
- Creatinine >2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline | Drug | Minocycline, Placebo |
Primary outcome
adverse event
Time frame: 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.
1 secondary outcome
comparative stroke scale
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Minocycline in people with Subarachnoid Aneurysm Hemorrhage, run by University at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.