Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization

• Status: Unknown status
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate, compared to non-treatment, the impact of a titrated dose (1 mg once a day, then 1 mg twice a day and finally a full 2 mg twice a day) of ketotifen on the adverse event profile emerging from a rapid peanut desensitization protocol, in children with established peanut allergy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gordon Sussman Clinical Research
• Collaborator: Mast Cell Pharmaceuticals Inc.
• Treatments: Ketotifen

Criteria

Inclusion Criteria:

• Age ≥ 8 years, all of either sex, any race, any ethnicity at the time of the initial visit

• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal >3.0 mm) and a positive in vitro IgE [CAP-FEIA] > 7 kUA/L

• A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts

• Provide signed informed consent.

Exclusion Criteria:

1. History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)

2. Currently participating in a study using an investigational new drug

3. Participation in any interventional study for the treatment of food allergy in the past 12 months

4. Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded

5. Poor control or persistent activation of atopic dermatitis

6. Moderate to severe persistent asthma

7. Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the NHLBI guidelines

8. Inability to discontinue antihistamines for skin testing

9. History of epilepsy or seizures

10. Diabetes