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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 January 2021 |
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Main ID: |
NCT03342053 |
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Date of registration:
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31/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139)
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Scientific title:
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An Open-Label Extension Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7234292 (ISIS 443139) in Huntington's Disease Patients Who Participated in Prior Investigational Studies of RO7234292 (ISIS 443139) |
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Date of first enrolment:
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January 2, 2018 |
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Target sample size:
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46 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03342053 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Germany
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United Kingdom
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Must have completed dosing in ISIS 443139-CS1
Key Exclusion Criteria:
- Any new condition or worsening of existing condition that could make the patient
unsuitable for participation or interfere with the patient participating in and/or
completing the study
Age minimum:
25 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
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Intervention(s)
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Drug: RO7234292 (RG6042)
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Primary Outcome(s)
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Percentage of Participants With Adverse Events
[Time Frame: From baseline up to 18 months]
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Secondary Outcome(s)
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Mean Change From Baseline in Huntington's Disease Cognitive Assessment Battery Composite Score
[Time Frame: Baseline to 15 Months]
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Mean Percentage Change in Whole Brain Volume Boundary Shift Integral From Baseline to 15 Months
[Time Frame: Baseline up to 15 months]
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RO7234292 CSF Trough Concentrations by Study Day Prior to Monthly and Bimonthly IT Administration of 120 mg RO7234292 (Primary Analysis)
[Time Frame: From baseline to Day 421]
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EEG Parameters: Mean Change From Baseline to 15 Months in Absolute Power [8-12Hz]
[Time Frame: Baseline to 15 Months]
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Mean Percentage Change in Caudate Volume Boundary Shift Integral From Baseline to 15 Months
[Time Frame: Baseline up to 15 months]
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Mean Percentage Change in Ventricular Volume Boundary Shift Integral From Baseline to 15 Months
[Time Frame: Baseline up to 15 months]
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CSF mHTT Protein Concentration
[Time Frame: Baseline up to 15 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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