Treatment of Acute Stroke With Cromolyn(Single Dose)

NCT01175525 | Unknown Phase 3

• 1 other identifier: 002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Stroke

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

sugar pill dissolved in water to be given 4 times a day 30 minutes prior to meals

Drug: sugar pill

Cromolyn

ACTIVE COMPARATOR

Cromolyn dose of 200mg(dissolved in water) will be given 4 times a day(30 minutes before a meal)

Drug: CROMOLYN

Interventions

CROMOLYN DRUG

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

Also known as: NASALCROM, GASTROCOM

Cromolyn

sugar pill DRUG

sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals

sugar pill

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Infarction of the anterior Circulation system.
• Both genders
• Age \> 20 years
• NIHSS \> 5 -

You may not qualify if:

• Non- ischaemic stroke
• Additional disease of the CNS
• Known allergy to cromolyn
• Diseae of mastocytosis
• Renal or Hepatic failure (acute or chronic)
• Inability to sign consent form (dementia or sensory aphasia)
• Lacunar infarctions
• INfarction present in cerebellum or brain stem -

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Edith wolfson medical Center

Holon, 58100, Israel

Location

MeSH Terms

Conditions

Stroke

Interventions

Cromolyn Sodium; Sugars

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Study Officials

• Yair Lampl, Neurologist

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yair Lampl, Neurologist

CONTACT

=972-3-5028512; y_lampl@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 5, 2010
• Last Updated: August 5, 2010

Record last verified: 2010-08

Locations

IL (1)