Trial · NCT02002884
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 | MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | Baseline and Week 4 | The full analysis set (FAS) was the subset in the safety evaluation set (SES) of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available (that is, all participants who had at least an AS score in clinical pattern flexed elbow or flexed wrist at baseline \[Day 1\] or Investigator's GICS at Day 29 \[Week 4\]). | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | Baseline and Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score in UL Treated Clenched Fist With Flexed Wrist at Week 4 | Baseline and Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in AS Score for Each Treated Clinical Pattern of the UL at Week 4 | Baseline up to Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Change From Baseline in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) Assessed With 'Questionnaire on Pain Caused by Spasticity (QPS)' | Baseline, Weeks 4, 8, and 14 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | MP: Child's/Adolescent's, and Parent's/Caregiver's GICS in UL at Week 4 | Week 4 | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Unit on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs of Special Interest (TEAESIs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of Serious TEAEs (TESAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs Related to Treatment Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs by Worst Intensity Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs by Worst Causal Relationship Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs by Final Outcome Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Occurrence of TEAEs Leading to Discontinuation Overall and Per Treatment Cycle | Baseline up to Week 66 | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Participants | COUNT_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.
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