Trial · NCT02913482
Results by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 165
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Selected Part 2 Dose of Risdiplam | Exploratory Part 1 - Risdiplam | 0.2 | mg/kg | ||
Part 2: Percentage of Infants Who Are Sitting Without Support for at Least 5 Seconds as Assessed by Item 22 of the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III) at Month 12 | Confirmatory Part 2 - Risdiplam | 29.3 | 90% Confidence Interval 17.84 to 43.07 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve a Score of 40 or Higher in the Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) at Month 12 | Confirmatory Part 2 - Risdiplam | 56.1 | 90% Confidence Interval 42.13 to 69.38 | Percentage of Participants | |
| Part 2: Percentage of Infants Achieving an Increase of >/= 4 Points in Their CHOP-INTEND Score From Baseline at Months 8 and 12 | Confirmatory Part 2 - Risdiplam | Month 8 | 87.8 | 90% Confidence Interval 76.05 to 95.07 | Percentage of Participants |
| Part 2: Percentage of Infants Achieving an Increase of >/= 4 Points in Their CHOP-INTEND Score From Baseline at Months 8 and 12 | Confirmatory Part 2 - Risdiplam | Month 12 | 90.2 | 90% Confidence Interval 79.05 to 96.60 | Percentage of Participants |
| Part 2: Percentage of Infants Achieving Head Control (Defined as a Score of >/= 3 for CHOP-INTEND Item 12) at Months 8, 12 and 24 | Confirmatory Part 2 - Risdiplam | Month 8 | 46.3 | 90% Confidence Interval 32.87 to 60.23 | Percentage of Participants |
| Part 2: Percentage of Infants Achieving Head Control (Defined as a Score of >/= 3 for CHOP-INTEND Item 12) at Months 8, 12 and 24 | Confirmatory Part 2 - Risdiplam | Month 12 | 53.7 | 90% Confidence Interval 39.77 to 67.13 | Percentage of Participants |
| Part 2: Percentage of Infants Achieving Head Control (Defined as a Score of >/= 3 for CHOP-INTEND Item 12) at Months 8, 12 and 24 | Confirmatory Part 2 - Risdiplam | Month 24 | 70.7 | 90% Confidence Interval 56.93 to 82.16 | Percentage of Participants |
| Part 2: Change From Baseline in the Total Raw Score of the BSID-III Gross Motor Scale at Months 12 and 24 | Confirmatory Part 2 - Risdiplam | Baseline | 1.85 | Standard Deviation 1.61 | Scores on a Scale |
| Part 2: Change From Baseline in the Total Raw Score of the BSID-III Gross Motor Scale at Months 12 and 24 | Confirmatory Part 2 - Risdiplam | Change from Baseline at Month 12 | 7.21 | Standard Deviation 5.71 | Scores on a Scale |
| Part 2: Change From Baseline in the Total Raw Score of the BSID-III Gross Motor Scale at Months 12 and 24 | Confirmatory Part 2 - Risdiplam | Change from Baseline at Month 24 | 12.89 | Standard Deviation 6.89 | Scores on a Scale |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Unable to maintain head upright (Head Control) at Month 8 | 36.6 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Wobbles (Head Control) at Month 8 | 14.6 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | All the time maintained upright (Head Control) at Month 8 | 39.0 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | No kicking (Ability to Kick [supine]) at Month 8 | 24.4 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Kicks horizontally; legs do not lift (Ability to Kick [supine]) at Month 8 | 58.5 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Upward (vertically) (Ability to Kick [supine]) at Month 8 | 7.3 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Touches leg (Ability to Kick [supine]) at Month 8 | 0 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | Touches toes (Ability to Kick [supine]) at Month 8 | 0 | Percentage of Participants | |
| Part 2: Percentage of Infants Who Achieve the Attainment Levels of a Subset of Motor Milestones Assessed in the Hammersmith Infant Neurological Examination Module 2 (HINE-2) at Month 8 | Confirmatory Part 2 - Risdiplam | No rolling (Rolling) at Month 8 | 56.1 | Percentage of Participants |
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
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GET https://conductscience.org/api/trials/v1/NCT02913482/results