Study of a Neuroprotective Drug to Limit the Extent of Damage From an Ischemic Stroke - Full Text View

Sponsors and Collaborators:	Medical College of Georgia National Institute of Neurological Disorders and Stroke (NINDS) University of Kentucky Oregon Health and Science University
Information provided by:	Medical College of Georgia
ClinicalTrials.gov Identifier:	NCT00630396

Purpose

The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.

Condition	Intervention	Phase
Stroke, Acute	Drug: Minocycline	Phase I Phase II

Drug Information available for: Minocycline Minocycline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Minocycline to Improve Neurologic Outcome (MINO Clinical Trial)

Further study details as provided by Medical College of Georgia:

Primary Outcome Measures:

The objective of this project is to determine the maximally tolerated intravenous dose of minocycline in ischemic stroke patients. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the pharmacokinetics of Minocycline in patients with ischemic stroke [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Determine the effect of the different doses of MC on plasma MMP-9 activity. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Gather preliminary data of the effect of different doses of MC on functional outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Dose level 1 = 3mg/kg IV(intravenous)initial dose, followed by 1.5mg/kg every 12 hours times 5 more doses.

Dose level 2 = 4.5mg/kg IV(intravenous) initial dose, followed by 2.25mg/kg every 12 hours times 5 more doses.

Dose level 3 = 6 mg/kg IV(intravenous) initial dose, followed by 3 mg/kg every 12 hours times 5 more doses.

Dose level 4 = 10 mg/kg IV (intravenous) initial dose, followed by 5 mg/kg every 12 hours times 5 more doses

Detailed Description:

Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration for treatment of infections and acne. However, doctors don't yet know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and doesn't have a lot of side effects, investigators at the Medical College of Georgia believe that it might be a safe and effective drug to improve the outcome in patients with stroke.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

over 18 years of age
acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
onset of symptoms less than 6 hours
measurable neurologic deficit

Exclusion Criteria:

allergy to tetracycline antibiotics
women of child-bearing potential
known hepatic and/or renal insufficiency
Thrombocytopenia
history of intolerance to minocycline
dizziness at the time of stroke or in the past month (by self-report)
aphasia likely to interfere with patients ability to report adverse effects
previous functional disability
stuporous or comatose
presence of another serious illness likely to confound the study
unlikely to be available for 90 day follow-up
severe stroke (NIH >22)
undergoing an interventional neuro-radiological intervention in first 12 hour

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630396

Contacts

Contact: David C Hess, MD	706-721-1691	dhess@mcg.edu
Contact: Joanne Rogalsky-Nacca, RN	706-721-5988	jrnacca@mcg.edu

Locations

United States, Kentucky
University of Kentucky	Recruiting
Lexington, Kentucky, United States, 40506-0057
Contact: L. Creed Pettigrew, MD 859-323-6702 cpetti@uky.edu
Principal Investigator: L. Creed Pettigrew, MD
United States, Oregon
Oregon Health Sciences University	Recruiting
Portland, Oregon, United States, 97239
Contact: Wayne Clark, MD 503-494-7225 clarkw@ohsu.edu
Contact: Rebecca Stone 503-418-1862 stoner@ohsu.edu
Principal Investigator: Wayne Clark, MD

Sponsors and Collaborators

Medical College of Georgia

National Institute of Neurological Disorders and Stroke (NINDS)

University of Kentucky

Oregon Health and Science University

Investigators

Principal Investigator:

David C Hess, MD

Medical College of Georgia

More Information

Responsible Party:	Medical College of Georgia ( David Charles Hess, MD )
Study ID Numbers:	RO1 NS055728-01A1, HAC File # 07-02-202
Study First Received:	February 28, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00630396
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medical College of Georgia:

stroke
ischemic
neuroprotection
minocycline
tPA
biomarkers
pharmacokinetics
antiapoptotic
anti-inflammatory

treatment
MMP-9
thrombolysis
MINOS
cerebrovascular stroke
cerebrovascular accident
Cerebral stroke
CVA (cerebrovascular accident)

Study placed in the following topic categories:

Minocycline
Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses

Nervous System Diseases
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009