Terminated
ENDEAR - NCT02193074 A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy

Please note, some trial-specific information on this page is sourced from clinicaltrials.gov.

About

Trial summary
TYPE INTERVENTIONAL
PHASE
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Phase

Clinical trials are done in different phases (0-4). Each phase provides important information about the drug. If a drug does not pass a particular phase, it cannot progress to the next phase. Visit the About Clinical Trials page to learn more.

PHASE3
CONDITION
  • Spinal Muscular Atrophy
  • INTERVENTIONS
    Interventions tooltip icon

    Interventions

    The drug, device, or procedure being tested.

      DRUG:nusinersen
      Administered by intrathecal (IT) injection as specified in the treatment arm.
      PROCEDURE:Sham procedure
      Small needle prick on the lower back at the location where the IT injection is normally made
    ENROLLMENT
    Icon tooltip

    Enrollment

    The number of participants needed to take part in this trial.

    122 participants
    (ACTUAL)
    Upto 210 Days Years
    (CHILD)
    LOCATIONS 31
    Key dates
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    Key dates

    When the trial is conducted - from the date the first participant is enrolled to the date of the last participants's final visit.

    August 19, 2014
    Trial start date
    November 21, 2016
    Trial end date
    More Information
    OTHER STUDY IDs
      ISIS 396443-CS3B

      2013-004422-29

    Clinical Trials Gov ID NCT02193074
    Last Updated

    We are currently unable to share site locations for this clinical trial. Please use the link to view (or find) site locations:

    CLINICALTRIALS.GOV

    Results

    Results from this trial have been made available. Some information may be redacted (edited) to protect privacy, publication rights, and confidential commercial information. To review the information please visit biogentrialtransparency.com.

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    CLINICALTRIALS.GOV
    Contact Us

    Please contact a clinical trial site directly to learn more about the trial. If no contact details are available, or for general inquiries, please contact the Biogen Clinical Trial Center.

    United States Biogen Clinical Trial Center

    866-633-4636

    clinicaltrials@biogen.com

    Find a trial location