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CIRARA in Large Hemispheric Infarction Analyzing Modified Rankin Scale (mRS) and Mortality (CHARM) (CHARM)

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ClinicalTrials.gov Identifier: NCT02864953
Recruitment Status : Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study evaluates the use of the investigational drug CIRARA versus placebo in patients with a large hemispheric infarction.

Condition or disease Intervention/treatment Phase
Brain Edema Stroke, Acute Drug: CIRARA (glyburide for injection) Drug: Placebo (for CIRARA) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Prospective, Double-blind, Phase 3 Trial of CIRARA (Glyburide for Injection) in Subjects With a Large Hemispheric Infarction
Study Start Date : February 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: CIRARA
CIRARA (glyburide for injection)
Drug: CIRARA (glyburide for injection)
Placebo Comparator: Placebo for CIRARA
Placebo (for CIRARA)
Drug: Placebo (for CIRARA)


Outcome Measures

Primary Outcome Measures :
  1. Proportion of participants with improvement in functional outcome at 90 days assessed via the modified Rankin Scale [ Time Frame: Change from baseline at 90 days ]

Secondary Outcome Measures :
  1. Proportion of participants with improvement in overall survival at 90 days [ Time Frame: Change from baseline at 90 days ]
  2. Proportion of participants with a reduction in midline shift at 72 hours assessed via non-contrast computed tomography [ Time Frame: Change from baseline at 72 hours ]
  3. Safety of CIRARA via collection of adverse events and serious adverse events [ Time Frame: Change from baseline through 15 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery territory
  2. A large lesion as defined by imaging
  3. Time to the start of infusion of study drug ≤ 9 hours after time of symptom onset
  4. Age ≥ 18 and ≤ 85 years

Exclusion Criteria:

  1. Commitment to decompressive craniectomy prior to enrollment
  2. Treatment with intra-arterial recombinant tissue plasminogen activator (rtPA) or by endovascular thrombectomy for clot disruption
  3. Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome
  4. Clinical signs of herniation
  5. Brain hemorrhage
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864953


Contacts
Contact: Remedy Pharmaceuticals, Inc.

Sponsors and Collaborators
Remedy Pharmaceuticals, Inc.
Investigators
Principal Investigator: Kevin N Sheth, MD Yale University
Principal Investigator: W. Taylor Kimberly, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: Remedy Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02864953     History of Changes
Other Study ID Numbers: RPI 301
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infarction
Stroke
Brain Edema
Ischemia
Pathologic Processes
Necrosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs