Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
NCT ID: NCT03225833
Last Updated: 2022-02-10
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2017-07-17
2021-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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WVE-120101 (Dose A) or placebo
WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
WVE-120101 (Dose B) or placebo
WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
WVE-120101 (Dose C) or placebo
WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
WVE-120101 (Dose D) or placebo
WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
WVE-120101 (Dose E) or placebo
WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
Interventions
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WVE-120101
WVE-120101 is a stereopure antisense oligonucleotide (ASO)
Placebo
0.9% Sodium Chloride
Eligibility Criteria
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Inclusion Criteria
* Ambulatory, male or female patients aged ≥25 - ≤65 years
* Clinical diagnostic motor features of HD, defined as Unified Huntington's Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
* Early manifest HD, Stage I or Stage II based on UHDRS Total Functional Capacity Scores ≥7 and ≤13
Exclusion Criteria
* Received investigational drug or implantable device in prior 3 months or investigational oligonucleotide in prior 6 months or 5 half-lives of the oligonucleotide, whichever is longer
* Clinically significant medical condition, unstable psychiatric symptoms, substance abuse, or pregnancy
* Inability to undergo brain MRI
* Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
25 Years
65 Years
ALL
No
Sponsors
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Wave Life Sciences Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Wave Life Sciences
Locations
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Westmead Hospital
Sydney, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Royal Melbourne Hospital
Carlton, Victoria, Australia
Monash Health
Clayton, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Calvary Health Care Bethlehem
Parkdale, Victoria, Australia
North Metropolitan Health Service
Perth, Western Australia, Australia
University of Alberta
Edmonton, Alberta, Canada
Centre For Movement Disorders
Toronto, Ontario, Canada
Center Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Aarhus Universitets Hospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital and University of Southern Denmark
Odense, , Denmark
Hospital Henri Mondor
Créteil, , France
Institut du Cerveau et de la Moelle Epinière
Paris, , France
George-Huntington-Institut GmbH
Münster, , Germany
Szpital Sw. Wojciecha
Gdansk, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Royal Devon and Exeter Hospital NHS Trust
Exeter, Devon, United Kingdom
Queen Elizabeth University Hospital - PPDS
Glasgow, Glasgow City, United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Countries
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References
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Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: April 2020. J Huntingtons Dis. 2020;9(2):185-197. doi: 10.3233/JHD-200002.
Rodrigues FB, Wild EJ. Huntington's Disease Clinical Trials Corner: February 2018. J Huntingtons Dis. 2018;7(1):89-98. doi: 10.3233/JHD-189001.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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WVE-HDSNP1-001
Identifier Type: -
Identifier Source: org_study_id
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