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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
WVE-120102 is a stereopure antisense oligonucleotide. It is administered monthly via intrathecal injection.
Westmead Hospital
Sydney, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Safety: Number of Patients With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 to Study Termination (maximum of 12 monthly doses)
Safety: Number of Patients With a Severe TEAE
Time frame: Day 1 to Study Termination (maximum of 12 monthly doses)
Safety: Number of Patients With Serious TEAEs
Time frame: Day 1 to Study Termination (maximum of 12 monthly doses)
Safety and Tolerability: Number of Patients Who Withdraw Due to TEAEs
Time frame: Day 1 to Study Termination (maximum of 12 monthly doses)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Centre Hospitalier de l-Universite de Montreal
Montreal, Quebec, Canada
...and 10 more locations