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A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-522227-99-00
Enrollment
134
Registered
2026-07-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington’s Disease

Brief summary

Change from Baseline to Month 36 in cUHDRS score

Detailed description

Change from Baseline to Month 36 in UHDRS-TFC, Change from Baseline to Month 36 in UHDRS-IS, The time to decline in TFC score by at least one or IS score by at least 10 over the treatment period, Change from Baseline to month 36 in UHDRS-TMS, Change from Baseline to Month 36 in SDMT, Change from Baseline to Month 36 in SWRT, Percent change from Baseline to steady state in blood mHTT protein, Change from Baseline to Month 36 in serum NfL, Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and TEAEs leading to participant withdrawal

Interventions

DRUGHTT227
DRUGPlacebo to 00mg tablet

Sponsors

Novartis Pharma AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from Baseline to Month 36 in cUHDRS score—

Secondary

MeasureTime frame
Change from Baseline to Month 36 in UHDRS-TFC, Change from Baseline to Month 36 in UHDRS-IS, The time to decline in TFC score by at least one or IS score by at least 10 over the treatment period, Change from Baseline to month 36 in UHDRS-TMS, Change from Baseline to Month 36 in SDMT, Change from Baseline to Month 36 in SWRT, Percent change from Baseline to steady state in blood mHTT protein, Change from Baseline to Month 36 in serum NfL, Incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and TEAEs leading to participant withdrawal—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 22, 2026