Treatment of Acute Stroke With Cromolyn(Single Dose)

August 2, 2010 updated by: Wolfson Medical Center

Mastocytes were proven to have a central rule in their development of the lipoid plaque of the vascular system. Mastocytes also has an important role in the stabilisation of the plaque in the building of the brain barrier. Different animal studies show that the inhibition of the mastocyte activity decreases significantly the risk of secondary bleeding post ischaemic stroke.It was also shown that post stroke inflammation process was also blocked by the inhibition of mastocytes.Other studies showed up to 100% decrease in the brain barrier disruption and post stroke oedema, after treatment with mastocyte inhibitors.

Cromolyn is a synthetic drug which has an anti-allergic effect by inhibition of the mastocytes. This drug is a well known,safe drug and is the main sub-substance that was used in the previously mentioned studies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Infarction of the anterior Circulation system.
  2. Both genders
  3. Age > 20 years
  4. NIHSS > 5 -

Exclusion Criteria:

  1. Non- ischaemic stroke
  2. Additional disease of the CNS
  3. Known allergy to cromolyn
  4. Diseae of mastocytosis
  5. Renal or Hepatic failure (acute or chronic)
  6. Inability to sign consent form (dementia or sensory aphasia)
  7. Lacunar infarctions
  8. INfarction present in cerebellum or brain stem -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: sugar pill
sugar pill dissolved in water to be given 4 times a day 30 minutes prior to meals
Drug: sugar pill
sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals
ACTIVE_COMPARATOR: Cromolyn
Cromolyn dose of 200mg(dissolved in water) will be given 4 times a day(30 minutes before a meal)
Drug: CROMOLYN
Cromolyn 200mg (dissolved in water) given 4 times a day
Other Names:
  • NASALCROM
  • GASTROCOM

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Investigators

  • Principal Investigator: Yair Lampl, Neurologist, Wolfson Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 2, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (ESTIMATE)

August 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2010

Last Update Submitted That Met QC Criteria

August 2, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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