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Treatment of Acute Stroke With Cromolyn(Single Dose)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Wolfson Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01175525
First received: August 2, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Stroke
 Drug: CROMOLYN
Drug: sugar pill
 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175525

Contacts
Contact: Yair Lampl, Neurologist =972-3-5028512 y_lampl@hotmail.com

Locations
Israel
Edith wolfson medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Lampl         y_lampl@hotmail.com    
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Yair Lampl, Neurologist Wolfson Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01175525     History of Changes
Other Study ID Numbers: 002
Study First Received: August 2, 2010
Last Updated: August 2, 2010
Health Authority: Israel: Ministry of Health
United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Brain Infarction
Brain Ischemia
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013