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NCT05358717CompletedPhase 2

A Study to Evaluate the Safety and Efficacy of PTC518 in Participants With Huntington's Disease (HD)

A Phase 2A, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of PTC518 in Subjects With Huntington's Disease

Source: ClinicalTrials.gov · Last updated 16 Jun 2026

Brief summary (registry, in English)

The primary goal of this study is to evaluate the safety and pharmacodynamic effects of PTC518 compared with placebo in participants with HD.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
159 (actual)
First submitted
27 Apr 2022
Start date
3 Jun 2022
Primary completion date
7 Feb 2025
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT05358717
EU CT number
2023-509835-26-00
EudraCT number
2021-003852-18

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 159
  • From 3 Jun 2022 to the primary completion date, 7 Feb 2025
  • 27 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receipt of an experimental agent within 90 days or 5 half-lives prior to Screening or anytime over the duration of this study, ribonucleic acid (RNA)- or deoxyribonucleic acid (DNA)-targeted HD-specific investigational agents such as antisense oligonucleotides, cell transplantation, or any other experimental brain surgery
  • Participation in an investigational study or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc) within 90 days prior to Screening or anytime over the duration of this study

Other illness

  • Any history of gene therapy exposure for the treatment of HD
  • Any medical history of brain or spinal disease that would interfere with the lumbar puncture process safety assessments
  • Any medical history or condition that would interfere with the ability to complete the protocol-specified assessments (for example, implanted shunt, conditions precluding magnetic resonance imaging \[MRI\] scans)

Other

  • Pregnancy, planning on becoming pregnant during the course of the study or within 6 months of end of treatment, or currently breastfeeding
    • Note: Other inclusion and exclusion criteria may apply.

Who the study is looking for

  • Genetically confirmed HD diagnosis with a cytosine-adenine-guanine (CAG) repeat length from 40 to 50, inclusive
    • Eligibility for HD-ISS Stage 2 Group (Parts A, B, and C):
  • A Unified Huntington's Disease Rating Scale (UHDRS)-Independence Scale (IS) score of 100
  • A UHDRS Total Functional Capacity (TFC) score of 13
  • A score between 0.18 and 4.93 inclusive on the normed version of the HD prognostic index (PINHD)
    • Eligibility for HD-ISS Mild Stage 3 Group (Parts D, E, and F):
  • A UHDRS Total Functional Capacity (TFC) score of 11 or 12, or a UHDRS TFC score of 13 with an UHDRS IS score of \<100

Age in the registry: 25 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (27)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Medizinische Universitaet Innsbruck
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InnsbruckAustriaCompleted
Monash Health
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ClaytonAustraliaUnknown status
Westmead Hospital
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SydneyAustraliaUnknown status
The Ottawa Hospital, Parkinson's and Movement Disorders Clinic
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Charite Universitaetsmedizin Berlin KöR
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Katholisches Klinikum Bochum gGmbH
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BochumGermanyCompleted
George-Huntington-Institut GmbH
Coordinator of this site? Confirm its status
MuensterGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
Hospital Universitario de Cruces
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BarakaldoSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario De Burgos
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BurgosSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Centre Hospitalier Universitaire D'Angers
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AngersFranceCompleted
Assistance Publique Hôpitaux de Marseille
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MarseilleFranceCompleted
The Barbery National Centre for Mental Health
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BirminghamUnited KingdomUnknown status
Cardiff University, Schools of Medicine and Biosciences
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CardiffUnited KingdomUnknown status
UCL Queen Square Institute of Neurology National Hospital for Neurology and Neurosurgery
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LondonUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
Azienda Unita Sanitaria Locale Di Bologna
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BolognaItalyCompleted
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyCompleted
Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyCompleted
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsCompleted
University of Otago, New Zealand Brain Research Institute
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ChristchurchNew ZealandUnknown status
The University of Texas Health Science Center at Houston- McGovern Medical School
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HoustonUnited StatesUnknown status
University of California San Diego
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La JollaUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
University of Washington Department of Neurology
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SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.