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Verapamil for Neuroprotection in Stroke

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Verapamil
Sponsored by
Global Neurosciences Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • 18 years of age and over
  • Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
  • Candidate for mechanical thrombectomy procedure
  • Onset of symptoms less than 8 hours
  • Measurable neurologic deficit (NIHSS >1)
  • Willingness to follow up with rehabilitation therapy
  • Anticipated life expectancy of at least 3 months

Exclusion Criteria:

  • Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)
  • Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min)
  • Thrombocytopenia (platelet count <75,000/mm3)
  • History of intolerance to verapamil
  • Previous functional disability (modified Rankin > 1)
  • Stuporous or comatose
  • Unlikely to be available for 90 day follow-up
  • Severe stroke (NIHSS>22)

Sites / Locations

  • Crozer Keystone Health SystemRecruiting

Outcomes

Primary Outcome Measures

Serious Adverse Event
Death
Serious Adverse Event
Hemorrhagic conversion

Secondary Outcome Measures

Full Information

First Posted
November 9, 2017
Last Updated
August 8, 2022
Sponsor
Global Neurosciences Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03347786
Brief Title
Verapamil for Neuroprotection in Stroke
Official Title
Intraarterial Verapamil for Neuroprotection in Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Global Neurosciences Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research study is to test an experimental procedure called intra-arterial delivery of verapamil in patients diagnosed with acute ischemic stroke. This study investigates the safety of intra-arterial delivery of verapamil, a drug used to treat vasospasm (spasm of a blood vessel), and how it affects recovery from stroke. Recruitment is limited to patients that have received mechanical thrombectomy as standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
Intra-arterial delivery of verapamil following mechanical thrombectomy procedure
Primary Outcome Measure Information:
Title
Serious Adverse Event
Description
Death
Time Frame
3 months
Title
Serious Adverse Event
Description
Hemorrhagic conversion
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent 18 years of age and over Acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia Candidate for mechanical thrombectomy procedure Onset of symptoms less than 8 hours Measurable neurologic deficit (NIHSS >1) Willingness to follow up with rehabilitation therapy Anticipated life expectancy of at least 3 months Exclusion Criteria: Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential) Hepatic and/or renal insufficiency (LFT's>3× upper limit of normal; CrCl < 30ml/min) Thrombocytopenia (platelet count <75,000/mm3) History of intolerance to verapamil Previous functional disability (modified Rankin > 1) Stuporous or comatose Unlikely to be available for 90 day follow-up Severe stroke (NIHSS>22)
Facility Information:
Facility Name
Crozer Keystone Health System
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mandy Binning
Email
MBinning@gnineuro.org
Phone
844-464-6387

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared as this is a pilot study to determine safety

Learn more about this trial

Verapamil for Neuroprotection in Stroke

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