Intracerebral HemorrhagePhase 1/2MACHNCT01805895
A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients
A Phase 1/2 study testing Minocycline in people with Intracerebral Hemorrhage, run by Augusta University at 1 site in United States.
Trial summary
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Minocycline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years of age or older.
- Intracerebral hemorrhage documented by CT scan
- The first dose of the drug can be administered within 12 hours of time last known to be at baseline
Who cannot join
- Allergy to tetracycline antibiotics
- Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- Hepatic and/or renal insufficiency (LFT's >3x upper limit of normal; Creatinine >2mg/dL)
- History of intolerance to minocycline
- National Institutes of Health Stroke Scale score of 4 or less
- Glasgow Coma Scale score of 5 or less
Show all 13Show fewer
- Surgical evacuation of hematoma planned within 24 hours
- Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes
- Thrombocytopenia (platelet count <75,000/mm3) or coagulopathy (INR >1.4)
- Previously not independent (prestroke modified Rankin scale score >2)
- Suspected of not being able to comply with the study protocol
- Unlikely to be available for 90 day follow-up
- Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
Official title: Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.
Read the detailed description
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.
- Conditions
- Intracerebral Hemorrhage
- Being tested
- Minocycline
- Keywords
- Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hemorrhagic Stroke, Hemorrhage, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Dynacin, Minocin
This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. Receives: Drug: Minocycline |
| Control | No intervention | This arm will not receive any minocycline. This arm will receive standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale
A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.
Measured: 90 days
Secondary outcomes (1)
Safety Assessment
Adverse events will be asses for 90 days. This will serve as our safety endpoint.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jeffrey Switzer, Augusta University
- Investigators
- Jeffrey A Switzer, DO, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805895
- Sponsor's protocol ID
- Pro00000718
- Acronym
- MACH
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2013
- Last updated
- 26 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fouda AY, Newsome AS, Spellicy S, Waller JL, Zhi W, Hess DC, Ergul A, Edwards DJ, Fagan SC, Switzer JA. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Stroke. 2017 Oct;48(10):2885-2887. doi: 10.1161/STROKEAHA.117.018658. Epub 2017 Sep 8.
PubMed 28887388
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
- ClinicalTrials.gov ID
- NCT01805895
- Acronym / sponsor ID
- MACH / Pro00000718
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Mar 2013 (estimated)
- Results
- Posted 26 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.
Detailed description
MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineThis intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. |
| Control | No intervention | –This arm will not receive any minocycline. This arm will receive standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older.
- Intracerebral hemorrhage documented by CT scan
- The first dose of the drug can be administered within 12 hours of time last known to be at baseline
Key exclusion criteria (13 listed)
- Allergy to tetracycline antibiotics
- Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
- Hepatic and/or renal insufficiency (LFT's >3x upper limit of normal; Creatinine >2mg/dL)
- History of intolerance to minocycline
- National Institutes of Health Stroke Scale score of 4 or less
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 |
|---|---|---|
| MinocyclineAlso: Dynacin, MinocinThis arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. | Drug | Minocycline |
Primary outcome
Modified Rankin Scale
Time frame: 90 days
A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales.
1 secondary outcome
Safety Assessment
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28887388Fouda AY, Newsome AS, Spellicy S, Waller JL, Zhi W, Hess DC, Ergul A, Edwards DJ, Fagan SC, Switzer JA. Minocycline in Acute Cerebral Hemorrhage: An Early Phase Randomized Trial. Stroke. 2017 Oct;48(10):2885-2887. doi: 10.1161/STROKEAHA.117.018658. Epub 2017 Sep 8.
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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.
Jeffrey A Switzer, DO principal investigator
Augusta University
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 Intracerebral Hemorrhage, run by Augusta University 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 26 Apr 2018. 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. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Modified Rankin Scale (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01805895, which also lists 1 linked publication.
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 26 Apr 2018.