2020 Postcard from Palm Springs
Highlights from the 2020 CHDI HD Therapeutics Conference are now here! This year’s Postcard covers HTT-lowering therapeutics, including an
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PIVOT-HD
PTC Therapeutics
The PIVOT-HD study offered by PTC Therapeutics Inc. is investigating PTC518 to evaluate the safety and pharmacodynamics effects compared with placebo in adult participants with HD.
This is a Phase 2a multicenter, randomized, placebo-controlled study to evaluate the safety and efficacy of PTC518 in participants with Huntington disease.
Status
Not Yet Recruiting in Canada
Formal Name
A Study to Evaluate the Safety and Efficacy of PTC518 in Participants with Huntington’s disease (HD)
Study Type
Interventional (Clinical Trial)
Purpose
Treatment.
Canadian Locations:
Québec
Location: Centre hospitalier de l’université de Montréal (CHUM)
Montréal, Québec, Canada, H2X 3H8
Status: Not Yet Recruiting
Ontario
Location: The Ottawa Hospital, Parkinson’s and Movement Disorders Clinic
Ottawa, Ontario, Canada, K1Y 4E9
Status: Not Yet Recruiting
British Columbia
Location: University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Status: Not Yet Recruiting
Contacts
Patient Advocacy, medinfo@ptcbio.com, 1-866-562-4620
Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria
- Genetically confirmed HD diagnosis with a cystosine-adenine-guanine (CAG) repeat length from 40-50, inclusive
Eligibility for HD-ISS Stage 2 Group (Parts A, B and C):
- A Unified Huntington’s Disease Rating Scale (UHDRS)-Independence Scale (IS) score of 100
- A UHDRS Total Functional Capacity (TFC) score of 13
- A score between 0.18 and 4.93 inclusive on the normed version of the HD prognostic index (PINHD)
Eligibility for HD-ISS Mild Stage 3 Group (Parts D, E and F):
- A UHDRS Total Functional Capacity (TFC) score of 11 or 12, or a UHDRS TFC score of 13 with an UHDRS IS score of <100
Key Exclusion Criteria (eligibility that would exclude you from this study)
- Receipt of an experimental agent within 90 days or 5 half-lives prior to Screening or anytime over the duration of this study, ribonucleic acid (RNA)- or deoxyribonucleic acid (DNA)-targeted HD-specific investigational agents such as antisense oligonucleotides, cell transplantation, or any other experimental brain surgery.
- Any history of gene therapy exposure for the treatment of HD
- Participation in an investigational study or investigational paradigm (such as exercise/physical activity, cognitive therapy, brain stimulation, etc.) within 90 days prior to Screening or anytime over the duration of this study
- Any medical history of brain or spinal disease that would interfere with the lumbar puncture process safety assessments
- Any medical history or condition that would interfere with the ability to complete the protocol-specified assessments (for example, implanted shunt, conditions precluding magnetic resonance imaging [MRI] scans)
- Pregnancy, planning on becoming pregnant during the course of the study or within 6 months of end of treatment, or currently breastfeeding
Source
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.