NCT05642442Phase 2Completed

A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-10-23Actual

Enrollment · participants169Actual

Source updated2026-01-15Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-30 · 1 field changed

Main study measure wording changed

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− Before

Measure: Change ~~from~~ Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score

+ After

Measure: Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score

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Study details

Conditions studied

Parkinson Disease; Tremor

Treatments or interventions studied

PlaceboDrug
SuvecaltamideDrugAlso known as JZP385, CX-8998, MK-8998

Primary outcomes · main study measures

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measure: Change From Baseline to Week 17 on the Essential Tremor Rating Scale (TETRAS) Composite Outcome Score; description: The TETRAS composite outcome score is the sum of modified items 1 - 11 of the TETRAS-ADL subscale and modified items 6a, 6b, and 7 of the TETRAS-PS. The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as eating, drinking, dressing, and other fine motor skills. The TETRAS-PS is a clinical rating scale that quantifies tremor in the head, face voice, limbs and trunk. Items 6a, 6b, and 7 of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 3, with 0 representing normal or slightly abnormal and 3 representing severely abnormal. The sum of the 14 items provides the TETRAS composite outcome score, which ranges from 0 - 42, with higher scores representing more severe tremor. The change from baseline is being reported where the greater the change from baseline indicates improvement in outcome.; timeFrame: Baseline to Week 17

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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