STudy to vAlidate telemetRic ECG Systems for firsT Dose Administration of Fingolimod (START)

• Status: Completed
• Trial end date: 2016-12-12
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated bradycardiac events during first dose observation of fingolimod in MS patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

Key Inclusion Criteria:

• Subjects with relapsing remitting MS.

• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy.

• Patients who had been previously on 2nd line therapies. It was understood that these patients satisfied the above mentioned criteria listed under a. in the past.

This also included patients, who were previously treated with fingolimod (regardless of whether or not they had already been treated within the START study) but discontinued treatment due to medical reasons.

• or patients with rapidly evolving severe RRMS (e.g. > 2 relapses with disease progression in one year and > 1 Gd-enhancing lesion or with a significant increase in T2 lesions compared to a recent MRI).

Key Exclusion Criteria:

• immunocompromised patients

• active infections

• pregnant or nursing women, women of childbearing potential unless using 2 reliable forms of contraception

• presence of malignancy (other than localized basal cell carcinoma of the skin).