This is a Phase II, randomized, placebo-controlled, double-blind, crossover study to evaluate the effect of multiple oral doses of CST-103 in the presence of CST-107 on Freezing of Gait (FOG) symptoms in subjects with Parkinson's Disease (PD).
Approximately 25 PD subjects with FOG symptoms will be enrolled in a 2 period, 2-way crossover design following study eligibility confirmation during the screening period. During each treatment period, subjects will receive daily doses of CST-103 co-administered with CST-107 or matching placebo for 14 days. Each treatment period will be separated by a washout period of at least 14 days. All subjects will complete clinical and pharmacodynamic assessments during each treatment period. Pharmacokinetic blood samples will be collected prior to and after study medication administration. Pharmacodynamic blood samples will also be collected to investigate the effects of CST-103 co-administered with CST-107 on inflammatory and neurodegenerative biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
CST-103 and matching placebo orange capsules; CST-107 and matching placebo white capsules
The University of Sydney
Sydney, New South Wales, Australia
Change from Baseline in Gait as Captured by Video Recordings
Subjects are requested to get up from a chair, walk to a square box shape taped to the floor five meters ahead and complete both a left and a right turn. Freezing of Gait (FOG) is tagged in the video at any point when a participant makes a sudden and involuntary cessation of normal progression of the feet through the task. The percentage time spent with FOG will be calculated by summing all FOG episodes and dividing by the total time to complete the task.
Time frame: Days 1 and 14 of each Treatment Period (two 14-day periods)
Freezing of Gait Symptoms
The Freezing of Gait Questionnaire (FOG-Q) is an assessment of FOG severity. The FOG-Q consists of six items. Responses to each item use a 5-point interval scale ranging from 0, absence of symptoms to 4, most severe stage. The total score is calculated as the sum of the individual items and ranges from 0 to 24 with a higher score indicating more severe FOG.
Time frame: Screening, Days 1 and 14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Reaction Time Task
Measures changes in cognition by testing psychomotor speed (selecting a flashing circle on a touch tablet screen as quickly as possible).
Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Paired Associates Learning Test
Measures changes in cognition by testing attention (remembering the location of an abstract pattern on a touch tablet screen).
Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Change from Baseline in CANTAB Verbal Recognition Test
Measures changes in cognition by testing memory (recall of 18 words flashed onto a touch tablet screen).
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Time frame: Screening, Days 1 and14 of each Treatment Period (two 14-day periods)
Digital wearable device (BioStamp)
A wireless device that measures physical activity and sleep (in hours/minutes) while at home
Time frame: Screening, Days 1-14 of each Treatment Period (two 14-day periods)