NL-OMON49037
Completed
N/A
An open-label, adaptive multiple-dose study to investigate the pharmacokinetics and pharmacodynamics of RO7234292 in csf and plasma, and safety and tolerability following intrathecal administration in patients with Huntington's disease. - BP40410
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Progressive Chorea
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed Informed Consent Form.
- •2\. Age 25 to 65 years, inclusive, at the time of signing Informed Consent Form.
- •3\. Manifest HD diagnosis, defined as a Diagnostic Confidence Level (DCL) score
- •4\. Independence Scale score of \>\= 70\.
- •5\. Genetically confirmed disease by direct DNA testing with a CAP score \> 400
- •(Zhang et al. 2011\), calculated as follows:
- •CAP \= Age x (CAG repeat length \- 33\.66\).
- •6\. Ability to read the words red, blue and green in the patient's native
- •7\. Ability to walk unassisted without a cane or walker and move about without a
- •wheelchair on a daily basis as reviewed at screening and baseline visit. Long
Exclusion Criteria
- •1\. History of attempted suicide or suicidal ideation with plan (i.e., active
- •suicidal ideation) that required hospital visit and/or change in level of care
- •within 12 months prior to screening.
- •Current suicidal ideation is demonstrated by the C\-SSRS per judgement of the
- •Investigator. If suicidal ideation is present, a risk assessment should be done
- •by an appropriately qualified mental health professional to assess whether it
- •is safe for the patient to participate in the study. Mild passive suicidal
- •ideation (i.e., occasional thoughts that life is not worth living or is hard)
- •without history of attempts or hospitalization over the past 12 months is
- •generally acceptable for study participation, but final decision on
Outcomes
Primary Outcomes
Not specified
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