Trial · NCT02292537
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15 | Baseline and Month 15 | ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using the multiple imputation method. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants Who Achieved a 3-Point Increase From Baseline in HFMSE Score at Month 15 | Baseline and Month 15 | ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline HFMSE data were imputed using multiple imputation. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants That Achieved Any New Motor Milestone at Month 15 | Month 15 | Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data. | Proportion of participants | NUMBER |
| SECONDARY | Number of New Motor Milestones Achieved Per Participant | Month 15 | Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data. | milestones achieved | MEAN |
| SECONDARY | Change From Baseline in Revised Upper Limb Module (RULM) Test | Baseline and Month 15 | ITT Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Missing postbaseline data were imputed using multiple imputation. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Proportion of Participants That Achieved Standing Alone | Month 15 | Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data. | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants That Achieved Walking With Assistance | Month 15 | Efficacy Set: All participants with a Day 456 Visit and all participants with a time difference of at least 463 days (456 days plus a 7-day window) between the date of first dose and the date for the final analysis. Based on imputed data where there was missing data. | Proportion of participants | NUMBER |
| SECONDARY | Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. All participants with AEs were reported in this outcome measure, whereas in Adverse Event section there was at 5% reporting threshold to be met. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Vital Sign Abnormalities | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening vital sign findings were reported as AEs and are presented in the AE/SAE section of the results. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Weight Abnormalities | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening weight abnormality findings were reported as AEs and are presented in the AE/SAE section of the results. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinically Significant Neurological Examination Abnormalities | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Neurological examination clinical significance was not collected. | ||
| SECONDARY | Number of Participants With Clinically Significant Physical Examination Abnormalities | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Physical examination clinical significance was not collected. | ||
| SECONDARY | Number of Participants With Clinically Significant Laboratory Parameter Abnormalities | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. Any new or worsening clinical laboratory parameter findings were reported as AEs and are presented in the AE/SAE section of the results. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal, Clinically Relevant Post-Baseline Worsening in Electrocardiogram (ECG) in Results | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. | participants | NUMBER |
| SECONDARY | Number of Participants Taking Any Concomitant Medication Related to Dosing Procedure or Sham Procedure | Baseline through Month 15 | Safety Set: All participants who were randomized and received at least 1 dose of study drug/sham procedure. | participants | NUMBER |
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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