PRECISION-HD2 - At a Glance
  • Sponsored by : Wave Life Sciences Ltd.
  • Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-120102 Administered Intrathecally in Patients With Huntington’s Disease
  • Involves:  administration of the WVE-120101 via an injection into the spinal canal.
  • Study type: Clinical Interventional trial
  • Phase: 1b/2a
  • Purpose : This clinical trial is testing a new drug that selectively lowers the mutant Huntington’s disease protein, whilst leaving the normal huntingtin protein relatively untouched. The primary objective is to understand whether the drug is safe in a small number of volunteers, before testing in a larger population and collecting evidence that the drug may work. 
  • Status: see trial sites below for details on recruitment status

 

Eligibility Criteria

 

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

 

TRIAL SITES

 

DENMARK

 

Trial site: Aarhus Universitets Hospital

 

Status: Recruiting 

Address: Aarhus, Denmark, 8200

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment

 

 

 

 

Trial site: Rigshospitalet

 

 

Status: Recruiting 

 

Address: Copenhagen, Denmark, 2100

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment

 



 

Trial site:  Odense University Hospital and University of Southern Denmark

 

Status: Recruiting 

Address: Odense, Denmark, 5000

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment

 

 

 

POLAND

 

Trial site: Szpital Sw. Wojciecha

 

Status: Recruiting 

Address: Gdańsk, Poland, 80-462

 

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment

 

 

 

 

Trial site: Instytut Psychiatrii i Neurologii

 

Status: Recruiting 

Address: Warsaw, Poland, 02-957

 

 

Contact: Not Available at the moment

 

 

Telephone: Not Available at the moment

 

 

Email:  Not Available at the moment

 

 

 

 

UNITED KINGDOM

 

Trial site: Royal Devon and Exeter Hospital NHS Trus

 

Status: Recruiting 

Address: Exeter, Devon, United Kingdom, EX2 5DW

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment

 

 

 

 

Trial site: Queen Elizabeth University Hospital – PPDS

 

Status: Recruiting 

Address: Glasgow, Glasgow City, United Kingdom, G12 0XH

 

 

Contact: Not Available at the moment

 

Telephone: Not Available at the moment

 

Email:  Not Available at the moment