Trial Search Results

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566).

The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Biogen

Stanford Investigator(s):

Intervention(s):

  • Drug: Nusinersen

Phase:

Phase 3

Eligibility


Key Inclusion Criteria:

   - Completed the Day 302 visit in study 232SM203 (NCT04089566) in accordance with the
   study protocol

Key Exclusion Criteria:

   - Treatment with another investigational therapy or enrollment in another interventional
   clinical study

   - Treatment with an approved therapy for SMA after the Day 302 Visit of Study 232SM203
   (NCT04089566)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting