Treatment of Acute Stroke With Cromolyn(Single Dose)

Phase 3

• Conditions: Acute Stroke
• Interventions: Drug: sugar pill; Drug: CROMOLYN

• Registration Number: NCT01175525
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-02
• Study First Submitted QC: 2010-08-02
• Last Update Submitted: 2010-08-02
• Study First Posted: 2010-08-05
• Last Update Posted: 2010-08-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sugar pill	sugar pill	sugar pill dissolved in water to be given 4 times a day 30 minutes prior to meals
Cromolyn	CROMOLYN	Cromolyn dose of 200mg(dissolved in water) will be given 4 times a day(30 minutes before a meal)

Trial Locations

Locations (1)

Edith wolfson medical Center; 🇮🇱 Holon, Israel