Treatment of Acute Stroke With Cromolyn(Single Dose)

Acute Stroke Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01175525
• Other study ID #: 002
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 2, 2010
• Last updated: August 2, 2010

Study information

• Verified date: August 2010
• Source: Wolfson Medical Center
• Contact: Yair Lampl, Neurologist
• Phone: =972-3-5028512
• Email: y_lampl[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Intervention Model: Parallel Assignment

Related Conditions & MeSH terms

• Acute Stroke

Intervention

Drug:
• CROMOLYN
Cromolyn 200mg (dissolved in water) given 4 times a day
• sugar pill
sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals

Locations

Country	Name	City	State
Israel	Edith wolfson medical Center	Holon

Sponsors (1)

Lead Sponsor	Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel,