TyPed - Natalizumab for the treatment of pediatric-onset multiple sclerosis in Portugal

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/29436
• EU PAS number:
  EUPAS28904
• Study ID:
  29436
• Official title and acronym:
  TyPed - Natalizumab for the treatment of pediatric-onset multiple sclerosis in Portugal
• DARWIN EU® study:
  No
• Study countries:
  Portugal
• Study description:
  The primary objective of the study is to characterize the efficacy of natalizumab in patients diagnosed with POMS who have been treated for > 12 months with natalizumab in Portugal. The secondary objective of the study is to characterize POMS patients treated with at least one natalizumab infusion in Portugal, in terms of safety and tolerability of the drug.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Multiple centres: 6 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 13/12/2017

Study start date

Actual: 23/04/2018

Date of final study report

Actual: 10/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

PRT_TYS_16_11106_TyPed_Protocol_v1_clean8965103509623323372_Redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

PRT-TYS-16-11106