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Trial · NCT01494701

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of participants that experience Adverse Events (AEs) and Serious Adverse EventsUp to 88 Days
PrimaryNumber of participants with clinically significant neurological examination abnormalitiesUp to 88 Days
PrimaryNumber of participants with clinically significant vital sign abnormalitiesUp to 88 Days
PrimaryNumber of participants with clinically significant physical examination abnormalitiesUp to 88 Days
PrimaryNumber of participants with clinically significant weight abnormalitiesUp to 88 Days
PrimaryNumber of participants with clinically significant laboratory parametersUp to 88 Days
PrimaryNumber or participants with clinically significant cerbrospinal fluid (CSF) laboratory parametersUp to 88 Days
PrimaryNumber of participants with clinically significant electrocardiograms (ECGs) abnormalitiesUp to 88 Days
PrimaryNumber of participants who use concomitant medicationsUp to 88 Days
PrimaryPK parameters of nusinersen (ISIS 396443): Maximum observed plasma drug concentration (Cmax)Plasma at 1, 2, 4 and 20 hours after dosing
PrimaryPK parameters of nusinersen: Time to reach maximum observed concentration (Tmax)Plasma at 1, 2, 4 and 20 hours after dosing
PrimaryPK parameters of nusinersen: Area under the plasma concentrations time curve from the time of the intrathecal (IT) dose to the last collected sample (AUCinf)Plasma at 1, 2, 4 and 20 hours after dosing
PrimaryPK parameters of nusinersen (ISIS 396443): Apparent terminal elimination half-life (t1/2), if possiblePlasma at 1, 2, 4 and 20 hours after dosing

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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