Sponsored by Vaccinex.
For an in-depth explanation of the trial, visit the Huntington Study Group’s web page here.
The SIGNAL trial is designed to assess the safety, tolerability, and effectiveness of VX15, a novel monoclonal antibody, in people with late prodromal (not yet diagnosed) or early manifest (early in the progression of the disease) HD. It is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study being conducted at approximately 30 sites across the United States and Canada. The trial seeks to enroll a total of 240 individuals, 21 or older.
Status
Complete (click here to read more)
Formal/Alternative Name
A Phase 2, Multi-center, Randomized, Double-blind, Placebo Controlled Study in Subjects With Late Prodromal and Early Manifest Huntington’s Disease (HD) to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of VX15/2503
Study Type
Interventional
Purpose
The SIGNAL trial is a Randomized Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of VX15/2503 in Subjects at Risk for or with Early Signs of Huntington’s Disease
Canadian Locations and Contact Information:
Edmonton, AB
Status: Not Recruiting
Location: University of Alberta
Coordinator: Paul McCann, 780-407-1614, paul.mccann@ahs.ca
Vancouver, BC
Status: Not Recruiting
Location: University of British Columbia
Coordinator: Mike Adurogbangba, MBBS, PMP, CCRP, 604-822-4872, madurogbangba@cmmt.ubc.ca
Montréal, QC
Status: Recruiting
Location: Centre Hospitalier de l’Université de Montréal, Montréal QC
Coordinator: Martine Comeau, 514-890-8000, ext 31523
Exclusion Criteria (eligibility that would exclude you from this study)
- Have participated in an investigational drug or device study within 30 days of the Baseline Visit
- Have had previous neurosurgery for HD or other movement disorders.
- Have a history of malignancy of any type within 2 years prior to Screening.
- Inability to undergo brain MRI.
- Visit here for more exclusion and inclusion criteria.
Source
ClinicalTrials.gov A service of the U.S. National Institutes of Health
This study is currently recruiting participants (see Contacts and Locations).
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.