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Parkinson’s and Movement Disorders

For information on Parkinson’s and Movement Disorders clinical trials, please contact Salma Khalil.

Current Recruiting Studies

Canadian Advanced Parkinson DUODOPA-Treated Patients Observational Study Evaluating Long-Term Health Outcome in Centers of Excellence (CADENCE)

From clinicaltrials.gov:

This is an open-label, postmarketing, observational study to document health outcomes, in Canadian patients with advanced Parkinson’s disease and long-term treatment with Duodopa (levodopa/carbidopa intestinal gel).

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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

From clinicaltrials.gov:

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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A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure

From clinicaltrials.gov:

A Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate efficacy, safety, and tolerability of ampreloxetine (TD-9855) in subjects with primary autonomic failures (MSA, PD, or PAF) and snOH. The study consists of 3 periods: (i) 2-week screening, (ii) 4-week randomized treatment, and (iii) 2-week follow up.

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Active Studies (not recruiting)

Multicenter, randomized, double-blind, placebo controlled study to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of GZ/SAR402671 in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variant.

From clinicaltrials.gov:

Primary Objectives:

Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as compared to placebo in patients with early-stage Parkinson’s disease (PD) carrying a GBA mutation or other pre-specified variants.
Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson’s disease carrying a GBA mutation or other pre-specified variants.

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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease

From clinicaltrials.gov:

To evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.

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