SELECT HD
Active, Not Recruiting
The study is a Phase 1b/2a and will look at the safety and how participants tolerate a new antisense oligonucleotide (ASO) in early stage disease, called WVE-003.
WVE-003 is a new investigational molecule that tries to reduce the toxic mHTT protein (while avoiding targeting the healthy, wild-type huntingtin protein, and preserving its beneficial effects in the central nervous system).
In the second quarter of 2023, Wave initiated the multi-dose portion of the trial. At this stage of the study, the company is enrolling existing participants from the single-dose portion of the trial and also screening new participants. Wave will be sharing additional single dose data and any available multidose data in the second half of 2023.
You can read more about SELECT-HD current status in Wave’s Community Letter of August 2023
Webinar with Wave on the updates of SELECT-HD clinical trial
Feb 9, 2023
Danlin Xu presents updates on SELECT-HD trial
Sept 17, 2022
Ages Eligible
for Study:
25 Years to 60 Years
Sexes Eligible
for Study:
All
Accepts Healthy Volunteers:
No
- Presence of the A variant of SNP3 on the same allele as the pathogenic CAG triplet expansion
- Ambulatory, male or female patients aged ≥25 to ≤60 years
- Clinical diagnostic motor features of HD, defined as Unified Huntington’s Disease Rating Scale (UHDRS) Diagnostic Confidence Score = 4
- UHDRS Total Functional Capacity Scores ≥9 and ≤13
- Malignancy or received treatment for malignancy, other than treated basal cell or squamous cell carcinoma of the skin, within the previous 5 years
- Received any other study drug, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer, with the exception of the following: Received WVE-120101 or WVE-120102 within the last 3 months.
- Implantable CNS device that may interfere with ability to administer study drug via lumbar puncture or undergo MRI scan
- Inability to undergo brain MRI (with or without sedation)
- Bone, spine, bleeding, or other disorder that exposes the patient to risk of injury or unsuccessful lumbar puncture
LOCATIONS
COUNTRIES
Denmark
- TRIAL SITE:Rigshospitalet
- Address:Copenhagen, Denmark, 2100
- Principal Investigator: Lena Hjermind, MD
France
- TRIAL SITE: Hopital Henri Mondor – Hospital
- Address: Créteil, France, 94010
- Principal Investigator: Katia Youssov, MD
- TRIAL SITE:Institut du Cerveau et de la Moelle Epiniere
- Address: Paris, France, 75646
- Principal Investigator: Alexandra Durr, MD, PhD
Germany
- TRIAL SITE: Katholisches Klinikum Bochum gGmbH
- Address: Bochum, Germany, 44791
- Principal Investigator: Carsten Saft, MD
- TRIAL SITE: George-Huntington-Institut GmbH
- Address: Muenster, Germany, 48149
- Principal Investigator: Ralf Reilman, MD
- TRIAL SITE: kbo-Isar-Amper-Klinikum Taufkirchen (Vils)
- Address: Taufkirchen, Germany, 84416
- Principal Investigator: Alzbeta Mühlbäck, MD
Italy
- TRIAL SITE: Centro Ricerche Cliniche Di Verona
- Address: Verona, Italy
- Principal Investigator: Tomasso Bovi, MD
Netherlands
- TRIAL SITE: Leiden University Medical Center
- Address: Albinusdreef 2, 2333 ZA Leiden, Netherlands
- Contact: Esther Marks, e.marks@lumc.nl
- Principal Investigator: Susanne de Bot, MD
- TRIAL SITE: Maastricht University Medical Center
- Address:P. Debyelaan 25, 6229 HX Maastricht, Netherlands
- Principal Investigator: Mayke Oosterloo, MD
- Contact: mayke.oosterloo@mumc.nl
Poland
- TRIAL SITE: Szpital Sw. Wojciecha
- Address:Gdańsk, Poland, 80-462
- Principal Investigator: Jaroslaw Slawek, MD
- TRIAL SITE: Instytut Psychiatrii I Neurologii
- Address:Warsaw, Poland, 02-957
- Principal Investigator: Grzegorz Witkowski, MD, PhD
Spain
- TRIAL SITE: Hospital de la Sanata Creu i Sant Pau
- Address: Barcelona, Spain, 08041
- Principal Investigator: Jaime Kulisevsky, MD, PhD
- TRIAL SITE: Hospital Universitario Ramón y Cajal
- Address: Madrid, Spain, 28034
- Principal Investigator: Jose Luis Lopez-Sendon Moreno, MD
UK
- TRIAL SITE: Royal Liverpool University Hospital
- Address: Liverpool, United Kingdom, L7 8XP
- Principal Investigator: Richard Rhys Davies, MA BMBCh PhD FRCP
- TRIAL SITE: Royal Hospital for Children, Pharmacy Aseptic Unit
- Address:Glasgow, Glasgow City, United Kingdom, G51 4TF
- Principal Investigator: Matthew Sheridan
- TRIAL SITE: Cardiff University, Schools of Medicine and Biosciences
- Address: Cardiff, Wales, United Kingdom, CF14 4XW
- Principal Investigator: Anne Rosser, PhD, MBBChir, MRCP
- TRIAL SITE: Royal Victoria Infirmary
- Address: Newcastle, United Kingdom
- Principal Investigator: Suresh Komati, MD
