Contact info-cru.neuro@mcgill.ca

CURRENT RECRUITING TRIALS

PARKINSON'S DISEASE

LUMA

A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson’s Disease in Participants Between the Ages of 30 and 80 (LUMA)

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson’s disease (PD). The main question researchers want to answer is: How long does it take for PD symptoms to worsen during BIIB122 treatment? Researchers will answer this and other questions by measuring the symptoms of PD over time using a variety of scoring tools.

The study will include adults aged 30 to 80 who were diagnosed with PD within 2 years of starting the study.

Patients must not be on or have previously taken Levadopa (or similar) treatment.

PARKINSON’S DISEASE BIOMARKERS STUDY (PDBS)

A multi-site longitudinal cohort study of Prodromal and Clinical Parkinson’s Disease

Parkinson’s disease (PD) develops slowly and is characterized by progressive and fluctuating motor changes. People with REM-sleep behavior disorder (RBD) are at risk of developing Parkinson’s disease in the future, and so may have mild motor changes. In general, it is difficult to monitor motor changes in Parkinson’s disease and REM sleep behavior disorder, because they can change from day to day.

Smartphones offer a potential solution to these challenges because they enable your motor state to be remotely and frequently monitored. The Roche PD Mobile Application v2 smartphone app combines active testing (small tests you do every day) with passive monitoring (the phone reading your mobility while you go about your day) to detect more subtle signs and symptoms of change.

The primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal PD and clinical PD.

The study is a one-year longitudinal biomarker study recruiting idiopathic RBD patients, Parkinson’s Disease patient and healthy controls. All participants receive a smartphone with the Roche PD Mobile Application, complete a number of active tests daily and their movements will be remotely monitored. Participants will undergo additional neurological exams and DaT-SPECT and MRI imaging in the study.

A second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD, in the peripheral nerves of the skin.

PARKINSON’S PROGRESSION MARKERS INITIATIVE (PPMI-2)

The Parkinson’s Progression Markers Initiative (PPMI) 2.0 Clinical – Establishing a Deeply Phenotyped PD Cohort

The purpose of this study is to obtain information from people with and without Parkinson disease (PD) so that researchers may better understand how Parkinson disease progresses, in order to inform better treatments.

This major international study was funded by the Michael J Fox Foundation. For more information on PPMI, click here.

ATAXIAS

ARROWHEAD ARO-ATXN2

A Phase 1 Placebo-Controlled Dose Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-ATXN2 in Adult Subjects With Spinocerebellar Ataxia Type 2

Adult participants with spinocerebellar ataxia type 2 (SCA2) who carry ≥33 cytosine, adenine, guanine (CAG) repeats in the ATXN2 gene, and who have met all protocol eligibility criteria will be randomized to receive a single dose of ARO-ATXN2 or placebo and be evaluated for safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

HUNTINGTON'S DISEASE

HOFFMAN LAROCHE- WE45491

Frequency of Selected Single Nucleotide Polymorphisms in Phase With the Mutant and Wild-Type HTT Alleles in Huntington Disease Gene Expansion Carriers

For participation in this epidemiological study, a single-day visit at the study site is required. Participants will be recruited from Huntington Disease clinics, and they will be asked to answer questions regarding their demographics, including sex, age, race and ethnicity, and their medical and medication history. At the end of the visit, a blood sample will be drawn to allow testing with a sequencing assay that is specifically designed for phasing single nucleotide polymorphisms (SNPs) on the wild-type Huntington (wtHTT) and mutant Huntington (mHTT) alleles.

HOFFMAN LAROCHE- GENERATION HD2

A Study to Evaluate the Safety, Biomarkers, and Efficacy of Tominersen Compared With Placebo in Participants With Prodromal and Early Manifest Huntington’s Disease

PRION DISEASES

IONIS ION717

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717 in Patients with Prion Disease

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.

This is a first-in-human, randomized, multi-center study in participants with prion disease. Eligible participants will receive ION717 and placebo. The study will consist of a screening period of up to 6 weeks, a 30-week double-blind treatment period, a 70-week open-label extension period and a 32-week post-treatment period. During the double-blind period, the order of ION717 and placebo doses will be randomized and blinded to participants, study sites and the Sponsor. During the open-label extension period, all participants will receive ION717. Multiple dose levels will be tested.

ACTIVE (NOT RECRUITING) TRIALS

Parkinson's Disease

HOFFMAN LAROCHE – PADOVA

A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson’s Disease

Currently, there is no approved medication to modify the progression of Parkinson’s disease (PD).

The PADOVA (Roche BN42358) clinical trial is studying the safety and efficacy of a drug for individuals with early Parkinson’s disease.

Aged 50 to 85, diagnosed with PD for at least 6 months and up to 3 years
Currently taking no more than 1 medication for PD (maximum daily dose of 450 mg of levodopa, 1 mg of rasagiline, or 10 mg of selegiline)
Able to undergo medical procedures such as MRI and DaTScans
Willing to use a smartphone application and smartwatch for the duration of the study
The study will last at least 76 weeks
There is no compensation for this study. However, costs related to participation in the study, such as travel and meals during visit days, will be reimbursed.