CURRENT RECRUITING TRIALS

REASON

A Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson’s Disease

The primary objective of this study is to evaluate the safety and tolerability of single and multiple doses of BIIB094 administered via intrathecal (IT) injection to participants with Parkinson’s Disease (PD). The secondary objective of this study is to evaluate the pharmacokinetic (PK) profile of BIIB094. The study is open for PD patients with verified presence or absence of mutations in the leucine-rich repeated kinase 2 (LRRK2) gene, but also for patients without any verified PD-related genetic mutation.

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SEQUOIA

A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD˗9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

The purpose of this study is to look at whether TD-9855 works and how safe when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on your general well-being and whether it can improve symptoms of neurogenic OH (nOH).

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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 such a remote monitoring approach can reliably and validly identify and track motor and non-motor symptoms in REM sleep behavior disorder and clinical PD.

For this study, 230 male and female participants will be recruited across 4 groups, at approximately 6 sites in Canada.

For more information about upcoming or recruiting trials, contact Martin Chevrier

UPCOMING TRIALS

NIO752
A Randomized, Participant, Investigator and Sponsor Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intrathecally Administered NIO752 in Participants With Progressive Supranuclear Palsy

Progressive supranuclear palsy is a rare brain disorder that causes problems with walking, balance and eye movements, and later with swallowing. The disorder results from deterioration of cells in areas of your brain that control body movement, coordination, thinking and other important functions. To date, there is no medicine shown to be effective in preventing or treating progressive supranuclear palsy.

The study drug, NIO752 blocks the production of a protein called tau that is involved in a group of neurodegenerative diseases known as tauopathies, including progressive supranuclear palsy and Alzheimer’s disease. By blocking the production of tau in the brain, NIO752 may reduce the development rate of the progressive supranuclear palsy.

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Prasinezumab
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

The purpose of this study is is to compare the effects, good or bad, of prasinezumab versus placebo on patients with early Parkinson’s disease who are taking standard medication to manage their disease symptoms.

PPMI 2.0
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.

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OAK
A Phase 3, 182-week, Open-Label, Extension Study to Investigate the Safety and Tolerability Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension (symptomatic nOH) in Subjects with Primary Autonomic Failure

Primary Objectives:

The purpose of this study is to look at how safe TD9855 is when taken over a longer period of time (three and a half years) to treat symptomatic neurogenic orthostatic hypotension (symptomatic nOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being.

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