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

NCT05642442 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: JZP385-2022022-001063-272024-515177-94-00
• Study Type: interventional
• Target: 169
• Locations: 4 countries
• Sites: 37

Brief Summary

This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks.

Conditions

Parkinson Disease; Tremor

Keywords

Suvecaltamide; Moderate tremor; Severe tremor; Parkinson's disease; JZP385; Residual tremor; T-type calcium channels; Movement disorders; Tremor; Parkinson's disease tremor

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline to Week 17

Secondary Outcomes (8)

• Percentage of Participants Who Improved (≥ 1-point Improvement) From Baseline to Week 17 on the Clinical Global Impression of Severity (CGI-S)

  Baseline to Week 17

• Change From Baseline to Week 17 on The Essential Tremor Rating Scale, Activities of Daily Living Subscale (TETRAS-ADL)

  Baseline to Week 17

• Percentage of Participants Who Improved (≥ 1 Point) From Baseline to Week 17 on the Patient's Global Impression of Severity (PGI-S)

  Baseline to Week 17

• Percentage of Participants Who Were Much Improved on the Patient's Global Impression of Change (PGI-C) at Week 17

  Baseline to Week 17

• Percentage of Participants Who Were Much Improved on the Clinician's Global Impression of Change (CGI-C) at Week 17

  Baseline to Week 17

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants who will receive a matching placebo during the Dose Titration, Optimization Period, and Maintenance Period.

Drug: Placebo

Sulvecaltamide

EXPERIMENTAL

Participants who will receive an optimal dose of suvecaltamide during the Dose Titration, Optimization Period, and Maintenance Period.

Drug: Suvecaltamide

Interventions

Placebo DRUG

Matching placebo capsule(s) administered every day (QD) orally. Titration may proceed at a rate of 1 matching placebo capsule per day every 7 days as required for optimal efficacy and tolerability up to a maximum number of 3 matching placebo capsules per day.

Placebo

Suvecaltamide DRUG

Suvecaltamide capsule administered every day (QD) orally. Titration may proceed at a rate of 10 mg suvecaltamide per day every 7 days as required for optimal efficacy and tolerability up to a maximum dose of 30 mg suvecaltamide per day.

Also known as: JZP385, CX-8998, MK-8998

Sulvecaltamide

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of clinically probable or clinically established Parkinson's disease (PD) meeting the Movement Disorder Society (MDS) 2015 criteria.
• Participants must be individually optimized on PD medications for the treatment of other cardinal signs of PD (bradykinesia, rigidity) per the judgment of the investigator.
• Participants must be on a stable dosing regimen of their permitted PD and/or other tremor (eg, propranolol) medications for the treatment of motor symptoms for at least 6 weeks prior to screening and do not anticipate the need to make any changes for the duration of the study. A lack of use of medications used to treat motor symptoms also must be stable for 6 weeks prior to screening and remain stable for the duration of the study.
• Participants have moderate to severe impairment associated with tremor at both the screening and baseline visits, as determined by all the following:
• A score of \> 21 on the TETRAS-ADL subscale; and
• CGI-S rating of tremor severity of \> 2 (at least moderate for participants ability to function).

You may not qualify if:

• Medical Conditions
• Female participants who are pregnant, nursing, or lactating or plan to become pregnant during the study or within 90 days of study completion.
• Known history or current evidence of other medical or neurological conditions that may cause or explain the participant's tremor, in the opinion of the investigator, including, but not limited to: psychogenic tremor; myoclonus or ataxia; cerebellar disease; traumatic brain injury; alcohol abuse or withdrawal; mercury poisoning; hyperthyroidism; pheochromocytoma; multiple sclerosis; clinically significant polyneuropathy in the opinion of the investigator; or family history or diagnosis of Fragile X syndrome. Note: Participants with a history of essential tremor are eligible.
• Hoehn \& Yahr stage 5 (confinement to bed or wheelchair unless aided).
• Participants who only experience tremor during their "OFF" periods.
• Severity of motor fluctuations or medication-induced dyskinesia that would interfere with the assessment of tremor and/or "ON"/"OFF" periods that are unpredictable per the opinion of the investigator.
• Clinically significant symptomatic orthostatic hypotension in the opinion of the investigator.
• Has evidence at screening of cognitive impairment as defined by a Montreal Cognitive Assessment (MoCA) score \< 22 or has a cognitive impairment that, in the investigator's opinion, would prevent completion of study procedures or the ability to provide informed consent.
• History or presence of gastrointestinal disease (including prior bariatric bypass surgery), hepatic (including ALT or AST ≥ 2 × ULN or total bilirubin ≥ 1.5 ULN), or severe renal impairment or end-stage renal disease, or any other condition that, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism, or excretion of suvecaltamide.
• Presence of significant cardiovascular disease at Screening
• History or presence of bipolar and related mood disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
• Prior/Concomitant Therapy
• Treatment-naïve patients (ie, those who have never tried PD medication) are excluded from participating in the study.
• Use of PRN medication/substance(s) that might produce or interfere with the evaluation of tremor on study visit days prior to discharge
• Prior or planned surgical intervention to treat PD, including but not limited to magnetic resonance-guided focused ultrasound thalamotomy, deep brain stimulation, ablative thalamotomy, and gamma knife thalamotomy.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (37)

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Keck School of Medicine of University of Southern California (USC)

Los Angeles, California, 90033, United States

Location

University of Colorado Hospital Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States

Location

Neurology of Central Florida Research Center LLC

Altamonte Springs, Florida, 32714, United States

Location

Parkinson's Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

NeuroTrials Research Inc.

Atlanta, Georgia, 30328, United States

Location

Hawaii Pacific Health

Honolulu, Hawaii, 96817, United States

Location

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky, College of Medicine, Department of Neurology

Lexington, Kentucky, 40536, United States

Location

The Nene and Jamie Koch Comprehensive Movement Disorders Center

Albuquerque, New Mexico, 87106, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Dent Neurologic Institute

Amherst, New York, 14226, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

South Shore Neurologic Associates PC

Patchogue, New York, 11772, United States

Location

University of Cincinnati Gardner Neuroscience Institute (UCGNI)

Cincinnati, Ohio, 45219, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

EverGreenHealth Neuroscience Institute

Kirkland, Washington, 98034, United States

Location

Zentrum f. klinische Forschung Dr. I. Schöll

Bad Homburg, 61350, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, 091111, Germany

Location

Curiositas-ad-sanum Beratungs-und Studien GmbH

Haag in Oberbayern, 83527, Germany

Location

Deutsche Klinik fur Diagnostik Helios Klinik Wiesbaden

Hessen, 65191, Germany

Location

Velocity Clinical Research Germany GmbH, Location Wiesbaden

Wiesbaden, 65189, Germany

Location

Neurologia Slaska Centrum Medyczne

Katowice, 40-689, Poland

Location

Centrum Medyczne Plejady

Krakow, 30-363, Poland

Location

Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M.i M. Nastaj Spólka Partnerska

Lublin, 20-064, Poland

Location

Maxxmed Centrum Zdrowia i Urody w Lublinie

Lublin, 20-080, Poland

Location

Gabinety Lekarskie Rivermed Sp. z o.o.

Poznan, 61-441, Poland

Location

ETG Neuroscience Sp. z o.o.

Warsaw, 02-777, Poland

Location

Hospital Universitario Cruces

Barakaldo, 48903, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor; Movement Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director Clinical Trial Disclosure & Transparency
• Organization: Jazz Pharmaceuticals, Inc.

ClinicalTrialDisclosure@JazzPharma.com

+1 215-832-3750

Study Officials

• Jazz Study Director

  Jazz Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: December 1, 2022
• Primary Completion: October 23, 2024
• Study Completion: November 11, 2024
• Last Updated: January 15, 2026
• Results First Posted: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

PL (6); US (21); DE (5); ES (5)