PRECISION-HD1
Terminated
UPDATES - March 30, 2021
Wave Life Sciences shared their two ASOs in Phase 1/2 trials in HD patients did not successfully lower mutant huntingtin.
ABOUT
SPONSOR
Wave Life Sciences Ltd.
PARTICIPANTS
60
Estimated Study Completion Date: December 2020
Webinar: What happened next?
Ages Eligible for Study:
25 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
DENMARK
COUNTRIES
TRIAL SITE:
University Hospital of Aarhus
Address: Aarhus, Denmark
TRIAL SITE:
Rigshospitalet
Address: Copenhagen, Denmark
TRIAL SITE:
Odense University Hospital and University of Southern Denmark
Address: Odense, Denmark
FRANCE
TRIAL SITE:
Hospital Henri Mondor
Address: Créteil, France
TRIAL SITE:
Institut du Cerveau et de la Moelle Epinière
Address: Paris, France,
GERMANY
TRIAL SITE:
George-Huntington- Institut GmbH
Address: Münster, Germany
POLAND
TRIAL SITE:
Szpital Sw. Wojciecha
Address: Gdańsk, Poland
TRIAL SITE:
Instytut Psychiatrii i Neurologii
Address: Warsaw, Poland
UNITED KINGDOM
TRIAL SITE:
Royal Devon and Exeter Hospital NHS Trust
Address: Exeter, Devon
TRIAL SITE:
Queen Elizabeth University Hospital – PPDS
Address: Glasgow City, United Kingdom
