Trial · NCT01839656
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 22
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit | Nusinersen 6 mg | 25.0 | Percent of participants | ||
| Percent of Participants Who Achieved Improvement in Motor Milestones as Assessed by Section 2 of the HINE at the Last Visit | Nusinersen 12 mg | 68.8 | Percent of participants | ||
| Event-free Survival at the End of Study | Nusinersen 6 mg | 25.0 | Percent of participants | ||
| Event-free Survival at the End of Study | Nusinersen 12 mg | 62.5 | Percent of participants | ||
| Percent of Participants With Improved Motor Function at the Last Visit as Assessed by the CHOP-INTEND Motor Function Scale | Nusinersen 6 mg | 25.0 | Percent of participants | ||
| Percent of Participants With Improved Motor Function at the Last Visit as Assessed by the CHOP-INTEND Motor Function Scale | Nusinersen 12 mg | 62.5 | Percent of participants | ||
| Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | Nusinersen 6 mg | Peroneal nerve | 1.88 | Standard Deviation 2.58 | mV |
| Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | Nusinersen 12 mg | Peroneal nerve | 2.81 | Standard Deviation 1.28 | mV |
| Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | Nusinersen 6 mg | Ulnar nerve | 0.776 | Standard Deviation 1.448 | mV |
| Change in Neuromuscular Electrophysiology at the Last Visit as Assessed by the Change From Baseline in CMAP Amplitude | Nusinersen 12 mg | Ulnar nerve | 0.685 | Standard Deviation 0.415 | mV |
| Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Nusinersen 6 mg | Any AE | 4 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Nusinersen 12 mg | Any AE | 16 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Nusinersen 6 mg | Any SAE | 3 | participants | |
| Number of Participants Experiencing Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | Nusinersen 12 mg | Any SAE | 13 | participants | |
| Concentration of Nusinersen in Cerebrospinal Fluid (CSF) | Nusinersen 6 mg | 12.2 | Standard Deviation 8.60 | nanograms/milliliter (ng/mL) | |
| Concentration of Nusinersen in Cerebrospinal Fluid (CSF) | Nusinersen 12 mg | 11.1 | Standard Deviation 4.99 | nanograms/milliliter (ng/mL) | |
| PK Parameters of Nusinersen in Plasma: Maximum Concentration (Cmax) | Nusinersen 6 mg | 396 | Standard Deviation 311 | ng/mL | |
| PK Parameters of Nusinersen in Plasma: Maximum Concentration (Cmax) | Nusinersen 12 mg | 829 | Standard Deviation 625 | ng/mL | |
| PK Parameters of Nusinersen in Plasma: Time to Reach Cmax (Tmax) | Nusinersen 6 mg | 2.09 | Standard Deviation 1.35 | hr | |
| PK Parameters of Nusinersen in Plasma: Time to Reach Cmax (Tmax) | Nusinersen 12 mg | 2.37 | Standard Deviation 1.25 | hr |
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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GET https://conductscience.org/api/trials/v1/NCT01839656/results