WHO ICTRP trial
Study of efficacy, safety and tolerability data for BAF312 compared to placebo…
EUCTR2012-003056-36-HU · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2012-003056-36-HU |
|---|---|
| Public title | Study of efficacy, safety and tolerability data for BAF312 compared to placebo in patients with secondary progressive multiple sclerosis |
| Scientific title | A multicenter, randomized, double-blind, parallel-group, placebo-controlled variable treatment duration study evaluating the efficacy and safety of Siponimod (BAF312) in patients with secondary progressive multiple sclerosis |
| Primary sponsor | Novartis Pharma Services AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;United States;Estonia;Slovakia;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Netherlands;Latvia;China;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech… |
| Conditions | Secondary progressive multiple sclerosis MedDRA version: 21.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C]… |
| Interventions | Product Name: Siponimod 2 mg tablet Product Code: BAF312A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Siponimod CAS Number: 1234627-85-0 Current Sponsor code: BAF312 Other descriptive name: BAF312 hemifumarate Concentration… |
| Registration date | Mar 9, 2012 |
| Target size | 1530 |
| Secondary IDs | CBAF312A2304 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: