GAMPP Trial

OFFICIAL TITLE.

A prospective, multicentre, randomised, stratified, parallel group design, confirmatory study to investigate the effect of Octagam treatment on the relapse rate during the postpartum period in patients suffering from relapsing remitting multiple sclerosis (“GAMMP Study”). Phase II/III Study.

STATUS. Under the auspices of the European Charcot Foundation.

SPONSOR. Octapharma AG (GAM107).

TEST DRUG. Octagam© 5%.

GROUPS OF PATIENTS.

Group I	first dose: 150 mg/kg Octagam 5%, followed by 150 mg/kg Octagam 5% in 4 week intervals.
Group II	first dose: 900 mg/kg Octagam 5% given over 3 days followed by 150 mg/kg Octagam 5% in 4 week intervals

NUMBER OF CENTERS. 42.

NUMBER OF PATIENTS. 168.

PRINCIPAL INVESTIGATOR. Prof. J. Haas

STEERING COMMITTEE.
Prof. J. Haas (chair), Prof. O.R. Hommes (Co-ordinating Investigator)

STUDY DURATION. 18 months.

END-POINTS.

Primary endpoint.

Relapse rate in the first 3 months of the post partum period of MS patients.

Secondary endpoints.

Number of patients with relapses within the first 6 months post partum, as well as within months 4 to 6 post partum.

- Neurological status.
- Tolerability of Octagam in post partum period.

END OF STUDY. January 2004.

RESULTS published in Multiple Sclerosis 2007; 13: 900-908.