Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/104369
• EU PAS number:
  EUPAS104368
• Study ID:
  104369
• Official title and acronym:
  Spinraza (nusinersen) SMA Pregnancy Exposure Study Within Existing SMA Registries
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  A Study of Spinraza (Nusinersen) Exposure in Pregnant Women With Spinal Muscular Atrophy (SMA) Within Existing SMA Registries
• Study status:
  Ongoing

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 30/11/2023

Actual: 15/12/2023

Study start date

Planned: 30/11/2023

Actual: 15/12/2023

Data analysis start date

Planned: 30/11/2023

Actual: 15/12/2023

Date of final study report

Planned: 31/10/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

232SM405 Protocol V2 Final 07Apr2023_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

NCT05789758

Link to Clinicaltrials.gov