Treatment of Acute Stroke With Cromolyn(Single Dose)

Wolfson Medical Center (WMC)

Status and phase: Unknown; Phase 3

Conditions: Acute Stroke

Treatments: Drug: sugar pill; Drug: CROMOLYN

Study type: Interventional

Funder types: Other

Identifiers

NCT01175525

002

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

0 participants in 2 patient groups, including a placebo group

sugar pill

Placebo Comparator group

Description:

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

Treatment:

Drug: sugar pill

Cromolyn

Active Comparator group

Description:

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

Treatment:

Drug: CROMOLYN