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

Sponsor

Gordon Sussman Clinical Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT01625715

Collaborator

Mast Cell Pharmaceuticals Inc. (Industry)

Enrollment

Location

Arms

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Peanut Allergies in Children	Drug: Ketotifen	Phase 2

Detailed Description

The development of a safe oral peanut challenge procedure permits patients that do not have severe life threatening allergic reactions, to be safely desensitized with the ability to maintain peanut tolerance . The peanut desensitization procedure is however associated with unpleasant allergic side effects mainly gastrointestinal and cutaneous manifestations. The use of premedication drugs may lessen these side effects and facilitate the peanut desensitization procedure. Ketotifen is a fast acting, noncompetitive, H1-receptor blocker (antihistamine/inverse agonist) that also inhibits the release of mediators from mast cells involved in hypersensitivity reactions.

The study will enroll 6 (4 in the peanut treatment group, 2 in the control group) children with a known history of peanut allergies. The treated subjects will be randomized in a 2:1 ratio into either a pre-treatment group (final dose of 2 mg bid ketotifen) or a control group. All subjects will undergo a one-day peanut desensitization protocol designed to enable the subject to tolerate 50 mg of peanut flour (initial escalation phase). After the initial escalation day achieving up to 50 mg of peanut flour, the dosing build-up will occur every two weeks through 44 weeks. Subjects will ingest the 50mg and increased doses of peanut flour at home (every day for 2 weeks) between each dose escalation. The target dose is 8000 mg of peanut flour. A maintenance dose will be given for 4 weeks following the last (highest dose) visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Case Controlled, Pilot Study to Evaluate the Effect of Ketotifen on the Adverse Events Associated With Peanut Desensitization in Children With Peanut Allergies.

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Case control Routine therapy during peanut desensitization
Experimental: ketotifen rising doses of ketotifen	Drug: Ketotifen titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day

Arm

Intervention/Treatment

No Intervention: Case control

Routine therapy during peanut desensitization

Experimental: ketotifen

rising doses of ketotifen

Drug: Ketotifen

titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day

Outcome Measures

Primary Outcome Measures

Adverse Event leading to discontinuation [up to 12 months]
Treatment with peanut flour causes ADRs that lead to treatment discontinuation.

Secondary Outcome Measures

Clinical Global Assessment [12 months]
Investigator's assessment of treatment impact on moderating adverse reactions associated with desensitization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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)
Currently participating in a study using an investigational new drug
Participation in any interventional study for the treatment of food allergy in the past 12 months
Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
Poor control or persistent activation of atopic dermatitis
Moderate to severe persistent asthma
Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the NHLBI guidelines
Inability to discontinue antihistamines for skin testing
History of epilepsy or seizures
Diabetes

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSCRI	Toronto	Ontario	Canada	M4V 1R2

Sponsors and Collaborators

Gordon Sussman Clinical Research
Mast Cell Pharmaceuticals Inc.

Investigators

Principal Investigator: Gordon L Sussman, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gordon Sussman Clinical Research

ClinicalTrials.gov Identifier:

NCT01625715

Other Study ID Numbers:

MCP-001

First Posted:

Jun 21, 2012

Last Update Posted:

Jun 21, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Gordon Sussman Clinical Research

peanut allergy

Additional relevant MeSH terms:

Hypersensitivity

Peanut Hypersensitivity

Ketotifen

Study Results

No Results Posted as of Jun 21, 2012