NCT03368664View on ClinicalTrials.gov

A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT

PHASE3Active, not recruitingINTERVENTIONAL

Enrollment

16

Participants

Timeline

Start Date

October 24, 2017

Primary Completion Date

May 4, 2021

Study Completion Date

December 31, 2025

Conditions

Multiple Sclerosis

Interventions

DRUG

Alemtuzumab GZ402673

Pharmaceutical form: solution, Route of administration: IV

DRUG

Glatiramer acetate

Pharmaceutical form: solution, Route of administration: subcutaneous (SC)

DRUG

Beta-Interferon

Pharmaceutical form: solution, Route of administration: SC / intramuscular (IM)

DRUG

Methylprednisolone

Pharmaceutical form: solution, Route of administration: IV

DRUG

Ranitidine

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Ceterizine

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Dexchlorpheniramine

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Paracetamol

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Acyclovir

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Prednisolone

Pharmaceutical form: tablet, Route of administration: oral

DRUG

Diphenydramine

Pharmaceutical form: solution, Route of administration: IV

DRUG

Other H1 antagonist

Pharmaceutical form: solution, Route of administration: IV

DRUG

Other H1 antagonist

Pharmaceutical form: tablet/pill, Route of administration: oral

Trial Locations (21)

1090

Investigational Site Number :0400001, Vienna

9000

Investigational Site Number :0560001, Ghent

20132

Investigational Site Number :3800001, Milan

34390

Investigational Site Number :7920003, Istanbul

67091

Investigational Site Number :2500002, Strasbourg

80131

Investigational Site Number :3800004, Napoli

94270

Investigational Site Number :2500001, Le Kremlin-Bicêtre

119602

Investigational Site Number :6430001, Moscow

129110

Investigational Site Number :6430004, Moscow

197022

Investigational Site Number :6430005, Saint Petersburg

197110

Investigational Site Number :6430002, Saint Petersburg

09126

Investigational Site Number :3800005, Cagliari

3015 CN

Investigational Site Number :5280001, Rotterdam

60-355

Investigational Site Number :6160002, Poznan

93-338

Investigational Site Number :6160003, Lodz

04-730

Investigational Site Number :6160001, Warsaw

3000-075

Investigational Site Number :6200001, Coimbra

06100

Investigational Site Number :7920002, Ankara

06500

Investigational Site Number :7920001, Ankara

Unknown

Investigational Site Number :7920004, Istanbul

WC1N 3JH

Investigational Site Number :8260002, London

All Listed Sponsors

lead

Genzyme, a Sanofi Company

INDUSTRY