Actively Recruiting

Phase 3
Age: 21Years - 70Years
All Genders
NCT07326709

A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease

Led by Novartis Pharmaceuticals · Updated on 2026-05-14

770

Participants Needed

10

Research Sites

214 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose is to assess safety and tolerability of votoplam and to determine whether votoplam slows disease progression in patients with early symptomatic Huntington's disease (HD) compared to the control arm. HTT227 - current compound code (former code is PTC518 from PTC Therapeutics), HTT227 is Novartis code under Novartis sponsorship.

CONDITIONS

Official Title

A Study to Investigate the Efficacy, Safety and Tolerability of Votoplam in Participants With Huntington's Disease

Who Can Participate

Age: 21Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent prior to participation
  • Ambulatory males or females aged 21 to 70 years inclusive at consent
  • Genetically confirmed Huntington's disease with CAG repeat length of 40 or more
  • UHDRS Independence Scale score of 90 or less
  • UHDRS Total Functional Capacity score equal to 13
  • UHDRS Total Motor Score between 7 and 25 inclusive
  • CAP score 100 of 70 or higher, calculated as Age at study entry × (CAG length - 30) / 6.49
Not Eligible

You will not qualify if you...

  • History of gene therapy, cell transplantation, or experimental brain surgery for Huntington's disease
  • Positive tests indicating active viral hepatitis infection
  • Immunodeficiency diseases including positive HIV test
  • Significant cardiac abnormalities such as clinically significant arrhythmias or second- or third-degree AV block without pacemaker
  • History of familial long QT syndrome or family history of Torsade de Pointes
  • Women of childbearing potential unless surgically sterile or using highly effective contraception during and for 8 months after treatment
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

CenExcel Rocky Mtn Clin Research

Englewood, Colorado, United States, 80113

Actively Recruiting

2

Georgetown University

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

3

Albany Medical College

Albany, New York, United States, 12208

Actively Recruiting

4

UBMD Neurology

Buffalo, New York, United States, 14202

Actively Recruiting

5

U of TX Health Science Ct

Houston, Texas, United States, 77030

Actively Recruiting

6

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

7

North York General Hospital

North York, Ontario, Canada, M2K1E1

Actively Recruiting

8

Centre de recherche du CHUM

Montreal, Quebec, Canada, H2W 1T8

Actively Recruiting

9

Novartis Investigative Site

Montreal, Quebec, Canada, H3A 2B4

Actively Recruiting

10

Novartis Investigative Site

London, United Kingdom, NW1 2BU

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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