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Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120101 Administered Intrathecally in Patients With Huntington's Disease

NCT03225833•Wave Life Sciences Ltd.

View on ClinicalTrials.gov

Summary

PRECISION-HD1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of WVE-120101 in adult patients with early manifest Huntington's disease (HD) who carry a targeted single nucleotide polymorphism (SNP) rs362307 (SNP1).

Eligibility

Age

25 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prescreened with targeted SNP on the same allele as the pathogenic CAG expansion
•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

•Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years.
•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

Locations (21)

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

Key Dates

Start Date

July 17, 2017

Primary Completion Date

May 11, 2021

Completion Date

May 11, 2021

Last Updated

February 10, 2022

Enrollment

ACTUAL participants

Conditions

Huntington's Disease

Interventions

WVE-120101

DRUG

Placebo

DRUG

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

NCT02855476

Huntington's Disease

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

NCT04120493

Huntington's Disease

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COMPLETEDPHASE2

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease

Inclusion Criteria

Exclusion Criteria

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

Safety and Proof-of-Concept (POC) Study With AMT-130 in Adults With Early Manifest Huntington's Disease

A Study to Evaluate the Effect of SAGE-718 on Cognitive Function in Participants With Huntington's Disease (HD)

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

A Study of Treatment With Pridopidine (ACR16) in Participants With Huntington's Disease

A Phase 2, to Evaluating the Safety and Efficacy of Pridopidine Vs Placebo for Symptomatic Treatment in Patients With Huntington's Disease