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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04617860
Other study ID # WVE-HDSNP2-002
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date September 24, 2019
Est. completion date April 29, 2021

Study information

Verified date January 2022
Source Wave Life Sciences Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

WVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.


Recruitment information / eligibility

Status Terminated
Enrollment 36
Est. completion date April 29, 2021
Est. primary completion date April 29, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patient successfully completed the Phase 1b/2a study with WVE-120102, WVE-HDSNP2-001. Exclusion Criteria: 1. Received an investigational drug other than WVE-120102, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer. 2. Inability to undergo brain MRI (with or without sedation). 3. Clinically significant medical finding on the physical examination other than HD that, in the judgment of the Investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
WVE-120102
WVE-120102 is a stereopure antisense oligonucleotide. It is administered monthly via intrathecal injection.

Locations

Country Name City State
Australia Royal Melbourne Hospital Carlton Victoria
Australia Monash Health Clayton Victoria
Australia Royal Brisbane & Women's Hospital Herston Queensland
Australia Alfred Health Melbourne Victoria
Australia Calvary Health Care Bethlehem Parkdale Victoria
Australia North Metropolitan Health Service Perth Western Australia
Australia Westmead Hospital Sydney New South Wales
Canada University of Alberta Edmonton Alberta
Canada Centre Hospitalier de l-Universite de Montreal Montreal Quebec
Canada Centre For Movement Disorders Toronto Ontario
Denmark Aarhus Universitets Hospital Aarhus
Denmark Rigshospitalet Copenhagen
Denmark Odense University Hospital and University of Southern Denmark Odense
France Hospital Henri Mondor Créteil
France Institut du Cerveau et de la Moelle Epinière Paris
Germany George-Huntington-Institut GmbH Muenster
Poland Szpital Sw. Wojciecha Gdansk
Poland Instytut Psychiatrii i Neurologii Warsaw
United Kingdom Royal Devon and Exeter Hospital NHS Trust Exeter Devon
United Kingdom Queen Elizabeth University Hospital - PPDS Glasgow Glasgow City

Sponsors (1)

Lead Sponsor Collaborator
Wave Life Sciences Ltd.

Countries where clinical trial is conducted

Australia,  Canada,  Denmark,  France,  Germany,  Poland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs) Day 1 to Study Termination (maximum of 12 monthly doses)
Primary Safety: Number of Patients With a Severe TEAE Day 1 to Study Termination (maximum of 12 monthly doses)
Primary Safety: Number of Patients With Serious TEAEs Day 1 to Study Termination (maximum of 12 monthly doses)
Primary Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs Day 1 to Study Termination (maximum of 12 monthly doses)
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