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Trial · NCT02292537

Results by group184

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15Sham Procedure-1.095% Confidence Interval -2.5 to 0.5scores on a scale
Change From Baseline in Hammersmith Functional Motor Scale - Expanded (HFMSE) Score at Month 15Nusinersen3.995% Confidence Interval 3.0 to 4.9scores on a scale
Proportion of Participants Who Achieved a 3-Point Increase From Baseline in HFMSE Score at Month 15Sham Procedure26.395% Confidence Interval 12.40 to 40.22Proportion of participants
Proportion of Participants Who Achieved a 3-Point Increase From Baseline in HFMSE Score at Month 15Nusinersen56.895% Confidence Interval 45.62 to 68.05Proportion of participants
Proportion of Participants That Achieved Any New Motor Milestone at Month 15Sham Procedure5.995% Confidence Interval 0.72 to 19.68Proportion of participants
Proportion of Participants That Achieved Any New Motor Milestone at Month 15Nusinersen19.795% Confidence Interval 10.93 to 31.32Proportion of participants
Number of New Motor Milestones Achieved Per ParticipantSham Procedure-0.2Standard Deviation 0.54milestones achieved
Number of New Motor Milestones Achieved Per ParticipantNusinersen0.2Standard Deviation 0.51milestones achieved
Change From Baseline in Revised Upper Limb Module (RULM) TestSham Procedure0.595% Confidence Interval -0.6 to 1.6scores on a scale
Change From Baseline in Revised Upper Limb Module (RULM) TestNusinersen4.295% Confidence Interval 3.4 to 5.0scores on a scale
Proportion of Participants That Achieved Standing AloneSham Procedure2.995% Confidence Interval 0.07 to 15.33Proportion of participants
Proportion of Participants That Achieved Standing AloneNusinersen1.595% Confidence Interval 0.04 to 8.16Proportion of participants
Proportion of Participants That Achieved Walking With AssistanceSham Procedure0.095% Confidence Interval 0.00 to 10.28Proportion of participants
Proportion of Participants That Achieved Walking With AssistanceNusinersen1.595% Confidence Interval 0.04 to 8.16Proportion of participants
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)Sham ProcedureAEs42participants
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)NusinersenAEs78participants
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)Sham ProcedureSAEs12participants
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)NusinersenSAEs14participants
Number of Participants With Clinically Significant Vital Sign AbnormalitiesSham ProcedureSystolic blood pressure <90 mmHg33participants
Number of Participants With Clinically Significant Vital Sign AbnormalitiesNusinersenSystolic blood pressure <90 mmHg80participants

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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