Trial · NCT02052791
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants that experience Adverse Events (AEs) and Serious Adverse Events | Up to 24 Months | |
| Primary | Number of participants with clinically significant neurological examination abnormalities | Up to 24 Months | |
| Primary | Number of participants with clinically significant vital sign abnormalities | Up to 24 Months | |
| Primary | Number of participants with clinically significant physical examination abnormalities | Up to 24 Months | |
| Primary | Number of participants with clinically significant weight abnormalities | Up to 24 Months | |
| Primary | Number of participants with clinically significant laboratory parameters | Up to 24 Months | |
| Primary | Number or participants with clinically significant cerbrospinal fluid (CSF) laboratory parameters | Up to Day 176 | |
| Primary | Number of participants with clinically significant electrocardiograms (ECGs) abnormalities | Up to 24 Months | |
| Primary | Change from Baseline in concomitant medications | Up to 24 Months | |
| Secondary | PK parameters of nusinersen (ISIS 396443) in CSF levels: Maximum observed plasma drug concentration (Cmax) | Pre-dose Day 176, Day 358 and Day 540 | |
| Secondary | PK parameters of nusinersen in CSF levels: Time to reach maximum observed concentration (Tmax) | Pre-Dose Day 176, Day 358 and Day 540 | |
| Secondary | PK parameters of nusinersen in CSF levels: Area under the plasma concentrations time curve from the time of the intrathecal (IT) dose to the last collected sample (AUCinf) | Pre-Dose Day 176, Day 358 and Day 540 |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02052791/registered