A Phase I Study of the Safety of Honeybee Venom Extract in Patients with Chronic Progressive Multiple Sclerosis

Joseph A. Bellanti, M.D., Principal Investigator
John R. Richert, M.D., Co-Principal Investigator
Dawn B. Wallerstedt, RN, FNP, Clinical Research Coordinator

Purpose: This Phase I study is being conducted to evaluate the safety of honeybee venom when administered to sixteen patients with primary or secondary progressive multiple sclerosis.

Study population: In order to qualify for this study, you must have:

Diagnosis of primary or secondary MS (not relapsing-remitting)
Chronic progressive phase for at least 3 years in duration
No worsening of symptoms over the last year
No exacerbations within the last 3 years
Between the ages of 21-55 years
No other medical problems, such as diabetes, liver, heart or kidney disease
No recent or current treatment with Methotrexate, Cytoxan, Iumran, Beta-interferon, Copaxone, honeybee venom or steroids
No allergies to honeybee venom, bee pollen or honey

Additionally, you must:

Live in an area accessible to Georgetown University Medical Center
Be able to commute to GUMC twice a week for the 1 year study duration

Study design: Study participants will be randomly assigned into one of four groups. Each of the four groups will begin treatment at two week intervals. Each group will receive a different dose of honeybee venom, ranging from a very low dose to a high dose. The highest dose used will be similar to that which is currently used by apitherapists in the field. Honeybee venom injections will be administered by a physician or nurse practitioner in two sessions per week, delivering 10 (0.1 mL) intradermal injections per session calculated for the monthly dose.

Outcome measures: A number of subjective and objective outcome measures will be utilized to monitor patient status. All patients will undergo neurologic examination at baseline, at 6 months, and at 12 months using the EDSS and FS score administered by a neurologist. Patients will perform a 9 hole Peg test ( a measure of upper extremity function and coordination), a Timed Ambulation (measures time it takes to ambulate 25 feet), and will provide their subjective impressions on two quality of life scales at baseline, 6 months, and at 12 months.

If you believe that you might meet these criteria and are interested in participating, please contact Dawn Wallerstedt, FNP, Clinical Research Coordinator at 202-687-8227.

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The International Center for Interdisciplinary Studies of Immunology
Geogretown University Medical Center