A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

NCT01805895 | Completed Phase 1 Results DMC

• 1 other identifier: Pro00000718
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracerebral Hemorrhage

Keywords

Stroke; Acute Intracerebral Hemorrhage; Intracerebral Hemorrhage; Hemorrhagic stroke; Hemorrhage; Minocycline

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days

Secondary Outcomes (1)

• Safety Assessment

  90 days

Study Arms (2)

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.

Drug: Minocycline

Control

NO INTERVENTION

This arm will not receive any minocycline. This arm will receive standard of care treatment.

Interventions

Minocycline DRUG

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.

Also known as: Dynacin, Minocin

Minocycline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Augusta University: lead
• American Heart Association: collaborator

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

• 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.

  PMID: 28887388 DERIVED

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hemorrhagic Stroke; Hemorrhage; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Dr Jeffrey Switzer
• Organization: Augusta University

jswitzer@augusta.edu

7067211691

Study Officials

• Jeffrey A Switzer, DO

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 26, 2018
• Results First Posted: April 26, 2018

Record last verified: 2018-03

Locations

US (1)