Trial · NCT03759665
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Impression of Change in Severity (CI-CS) [Fields et al 2021] | (CI-CS comparing Baseline [Day 1] with IB1001 versus the end of 6-weeks treatment with IB1001 [approximately Day 42]) MINUS (CI-CS comparing the end of 6-weeks treatment with IB1001 [approximately Day 42] versus end of 6-weeks post-treatment washout); | Modified Intention to Treat (mITT) Analysis Set is defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). | score on a scale | MEAN |
| SECONDARY | Key Secondary Endpoint: Individual Components of the CI-CS | Baseline to end of treatment with IB1001 (Parent Study 6-weeks treatment); End of treatment with IB1001 to the end of post 6-week treatment washout. | Modified Intention to Treat (mITT) Analysis Set is defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 29 participants had values for the CI-CS analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | score on a scale | MEAN |
| SECONDARY | Key Secondary Endpoint: Change in Severity Based on Average CI-S | (CI-S comparing baseline period [average for Visit 1 and 2] and end of treatment period [average for Visit 3 and 4]) minus (change in CI-S between end of treatment period [average for Visit 3 and 4] and end of washout period [average for Visit 5 and 6]). | Modified Intention to Treat (mITT) Analysis Set is defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). | score on a scale | MEAN |
| SECONDARY | Key Secondary Endpoint: CI-CS Score Reclassified on a 3-Point Scale | Baseline to end of treatment with IB1001 (Parent Study 6-weeks treatment); End of treatment with IB1001 to the end of post 6-week treatment washout | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 29 participants had values for the CI-CS analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Key Secondary Endpoint: CI-CS Score for the Non-Primary Anchor Test | CI-CS of the non-primary anchor test was evaluated, comparing the CI-CS of Visit 4 (end of treatment) versus Visit 2 (baseline) and of Visit 6 (end of washout) versus Visit 4 (end of treatment) as done for the primary anchor test. | Modified Intention to Treat (mITT) Analysis Set is defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 22 participants had values for the CI-CS Score for the Non-Primary Anchor Test analysis in the Treatment with IB1001 period and 20 participants in the Post-Treatment washout period | score on a scale | MEAN |
| SECONDARY | Spinocerebellar Ataxia Functional Index (SCAFI) [Schmitz-Hübsch et al, 2008] | Change values were calculated for each period, i.e. treatment with IB1001 (comparing the end of treatment (Visit 4) with baseline (Visit 2)) and post-treatment washout (comparing the end of washout (Visit 6) with the end of treatment (Visit 4)). | Modified Intention to Treat (mITT) Analysis Set is defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 26 participants had values for the SCAFI Total score analysis in the Treatment with IB1001 period and 25 participants in the Post-Treatment washout period | Z-scores | MEAN |
| SECONDARY | Scale for Assessment and Rating of Ataxia (SARA) Score [Schmitz-Hübsch Etal, 2006; Subramony, 2007] | Baseline to end of treatment with IB1001 (Parent Study Day 42); End of treatment with IB1001 to the end of post treatment washout | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 28 participants had values for the SARA analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | score on a scale | MEAN |
| SECONDARY | EuroQuol- 5 Dimension (EQ-5D) Quality of Life Scale: Visual Analogue Scale (VAS) | Baseline to end of treatment with IB1001 (Parent Study 6-week treatment): observed VAS values at visit 4; End of treatment with IB1001 to the end of post treatment washout: observed VAS values at visit 6. | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 28 participants had values for the EQ-5D VAS analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | score on a scale | MEAN |
| SECONDARY | Modified Disability Rating Scale (mDRS) [Iturriaga et al. 2006] | Baseline to end of treatment with IB1001 (Parent Study 6-weeks treatment); End of treatment with IB1001 to the end of post treatment washout. | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 28 participants had values for the mDRS analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period | score on a scale | MEAN |
| SECONDARY | Investigator's Clinical Global Impressions of Change (CGI-c) | Baseline to end of treatment with IB1001 (Parent Study 6-weeks treatment); End of treatment with IB1001 to the end of post treatment washout. | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 28 participants had values for theInvestigator's CGI-C analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | score on a scale | MEAN |
| SECONDARY | Parent/Caregiver's Clinical Global Impression of Change (CGI-C) | Baseline to end of treatment with IB1001 (Parent Study 6-week treatment); End of treatment with IB1001 to the end of post treatment washout | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 26 participants had values for the Parent/Caregiver's CGI-C analysis in the Treatment with IB1001 period and 25 participants in the Post-Treatment washout period. | score on a scale | MEAN |
| SECONDARY | Patient's Clinical Global Impressions (CGI) if Able | Baseline to end of treatment with IB1001 (Parent Study 6-weeks treatment); End of treatment with IB1001 to the end of post treatment washout. | The Modified Intention to Treat (mITT) analysis set was defined as all patients who receive at least one dose of the study drug and with one video recording during the baseline period (Visit 1 or 2, or both) and treatment period (Visit 3 or Visit 4, or both). The overall mITT comprised 29 participants. Of these, 28 participants had values for the Patient's CGI if Able analysis in the Treatment with IB1001 period and 27 participants in the Post-Treatment washout period. | score on a scale | MEAN |
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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