Zenapax to Treat Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001934
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Zenapax to Treat Multiple Sclerosis
• Scientific title: Effect of the Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (IL-2R-Alpha; Zenapax(Registered Trademark)) on Inflammatory Activity in the CNS in MS in a Baseline-to-Treatment, Cross-Over, MRI-Controlled Single Center Phase I/II Trial
• Date of first enrolment: September 1999
• Target sample size: 22
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001934
• Study type: Interventional
• Study design: Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

- INCLUSION CRITERIA

Between the ages of 18 and 65 years, inclusive.

Subjects with relapsing-remitting or secondary progressive Multiple Sclerosis who have had
more than 1 relapse within 18 months preceding study enrollment.

EDSS score between 1 - 6.5, inclusive.

Give written informed consent prior to any testing under this protocol, including
screening/pre-treatment tests and evaluations that are not considered part of the
subject's routine care.

Patients who have failed standard IFN-beta therapy.

To be eligible to proceed to the treatment phase of the study, subjects must have at least
2 Gd-enhancing lesions or greater in the 3 pre-treatment MRI scans (an average of at least
0.67 Gd-enhancing lesions per scan).

In patients with high inflammatory activity and high relapse rates it has been our
experience that the requirement of steroid therapy for the treatment of relapses may
prolong the baseline phase. In patients with high disease activity who require steroid
therapy and quickly afterwards demonstrate disease activity again, the investigator
retains the option to enroll patients with less than the stipulated baseline months in
order to initiate daclizumab therapy as quickly as possible. Since treatment escalation
would otherwise require therapy with mitoxantrone or cyclophosphamide, which both have
substantial toxicity, this step is in the best interest of the patient.

EXCLUSION CRITERIA:

Diagnosis of primary progressive MS, defined as gradual progression of disability from the
onset without relapses.

Abnormal screening/pre-treatment blood tests exceeding any of the limits defined below:

Alanine transaminase (ALT) or aspartate transaminase (AST) greater than two times the
upper limit of normal;

Total white blood cell count less than 3,000/mm(3);

CD4+ count less than 320/mm(3);

Platelet count less than 80,000/mm(3);

Creatinine greater than 2.0 mg/dL.

Concurrent, clinically significant (as determined by the investigator) cardiac,
immunologic, pulmonary, neurologic, renal, and/or other major disease.

Any contraindication to monoclonal antibody therapies.

Patients who are HIV+ since the effects of anti-Tac are not defined in these patients.

If prior treatment was received, the subject must have been off treatment for the required
period prior to enrollment.

Prior treatment with any other investigational drug or procedure for MS.

History of alcohol or drug abuse within the 5 years prior to enrollment.

Male and female subjects not practicing adequate contraception.

Female subjects who are not post-menopausal or surgically sterile must be using an
acceptable method of contraception. Acceptability of various methods of contraception
will be at the discretion of the investigator. Written documentation that the subject is
post-menopausal or surgically sterile must be available prior to study start.

Unwillingness or inability to comply with the requirements of this protocol including the
presence of any condition (physical, mental, or social) that is likely to affect the
subject's returning for follow-up visits on schedule.

Previous participation in this study.

Breastfeeding patients.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Zenapax

Primary Outcome(s)

Change in contrast-enhancing lesions on brain MRI. [Time Frame: Yes]

Secondary ID(s)

990169

99-N-0169

Source(s) of Monetary Support

Please refer to primary and secondary sponsors