Treatment of Acute Stroke With Cromolyn(Single Dose)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01175525
Recruitment Status : Unknown
Verified August 2010 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 5, 2010
Last Update Posted : August 5, 2010
Information provided by:
Wolfson Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Acute Stroke Drug: CROMOLYN Drug: sugar pill Phase 3

Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)
Cromolyn 200mg (dissolved in water) given 4 times a day
Other Names:

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

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 identifier (NCT number): NCT01175525

Contact: Yair Lampl, Neurologist =972-3-5028512

Edith wolfson medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Lampl   
Sponsors and Collaborators
Wolfson Medical Center
Principal Investigator: Yair Lampl, Neurologist Wolfson Medical Center Identifier: NCT01175525     History of Changes
Other Study ID Numbers: 002
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents