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

NCT ID: NCT05642442

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-11-11

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.

Detailed Description

Participants will be randomized 1:1 to receive suvecaltamide or placebo and stratified by the Essential Tremor Rating Scale (TETRAS) composite outcome score (≤ 17 or > 17) as assessed at baseline. The maximum total duration of the study for each participant will be 23 weeks, with a maximum treatment duration of 17 weeks. For each participant, the study consists of a Screening Period (up to 4 weeks), a 5-week Dose Titration and Optimization Period, a 12-week Maintenance Period, and a 2-week Safety Follow-up Period.

Conditions

Parkinson Disease; Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Sulvecaltamide

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

Group Type: EXPERIMENTAL

Suvecaltamide

Intervention Type: 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.

Interventions

Placebo

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.

Intervention Type: DRUG

Suvecaltamide

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.

Intervention Type: DRUG

Other Intervention Names

JZP385; CX-8998; MK-8998

Eligibility Criteria

Inclusion Criteria

• 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:

1. A score of > 21 on the TETRAS-ADL subscale; and

2. CGI-S rating of tremor severity of > 2 (at least moderate for participants ability to function).

Exclusion Criteria

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.
• Use of PRN medications to treat tremor or continuous infusion of PD medications. Note: Use of dopaminergic rescue medications (eg, PRN use of carbidopa/levodopa, including levodopa inhalation powder) for non-tremor PD symptoms (eg, rigidity or bradykinesia) is permitted.
• Botulinum toxin injection for the treatment of tremor in the 6 months before screening or planned use at any time during the study. Note: Use of botulinum toxin for other reasons (eg, cosmetic, excessive salivation, dystonia) is permitted as long as the location of use is anatomically distinct from the region with tremor.
• Use of prescription or nonprescription drugs or other products (eg, St. John's Wort) known to be inducers of cytochrome 3A4 (CYP3A4) (cause > 30% reduction of sensitive substrates area under the plasma concentration-time curve [AUC]), which cannot be discontinued at least 4 weeks before baseline, or planned use at any time during the study.
• Use of prescription or nonprescription drugs or other products (eg, grapefruit) known to be strong or moderate inhibitors of CYP3A4, which cannot be discontinued 2 weeks or 5 half-lives, whichever is longer, before baseline, or planned use at any time during the study.
• Use of proton pump inhibitors, which cannot be discontinued at least 2 weeks before baseline, or planned use at any time during the study. (Occasional use of antacids or histamine receptor type 2 [H2] receptor antagonists will be permitted, but antacids should be taken at least 4 hours apart from study intervention; H2 receptor antagonists should be taken at least 4 hours after and/or 12 hours before study intervention).

Diagnostic Assessments

• Known use of recreational drugs, inclusive of the following: phencyclidine, cocaine, opioids, barbiturates, amphetamines, or 3,4-methylenedioxymethamphetamine [ecstasy].
• Opioid use at stable doses, either regularly or PRN, for pain management, as prescribed, is permitted. Use of cannabinoids (including cannabidiol) is permitted if there is no impact on tremor symptoms per the judgment of the investigator.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jazz Study Director

Role: STUDY_DIRECTOR

Jazz Pharmaceuticals

Locations

Movement Disorders Center of Arizona

Scottsdale, Arizona, United States

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

Los Angeles, California, United States

University of Colorado Hospital Anschutz Outpatient Pavilion

Aurora, Colorado, United States

Neurology of Central Florida Research Center LLC

Altamonte Springs, Florida, United States

Parkinson's Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, United States

NeuroTrials Research Inc.

Atlanta, Georgia, United States

Hawaii Pacific Health

Honolulu, Hawaii, United States

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Kentucky, College of Medicine, Department of Neurology

Lexington, Kentucky, United States

The Nene and Jamie Koch Comprehensive Movement Disorders Center

Albuquerque, New Mexico, United States

Albany Medical College

Albany, New York, United States

Dent Neurologic Institute

Amherst, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

South Shore Neurologic Associates PC

Patchogue, New York, United States

University of Cincinnati Gardner Neuroscience Institute (UCGNI)

Cincinnati, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Central Texas Neurology Consultants

Round Rock, Texas, United States

EverGreenHealth Neuroscience Institute

Kirkland, Washington, United States

Zentrum f. klinische Forschung Dr. I. Schöll

Bad Homburg, , Germany

Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, , Germany

Curiositas-ad-sanum Beratungs-und Studien GmbH

Haag in Oberbayern, , Germany

Deutsche Klinik fur Diagnostik Helios Klinik Wiesbaden

Hessen, , Germany

Velocity Clinical Research Germany GmbH, Location Wiesbaden

Wiesbaden, , Germany

Neurologia Slaska Centrum Medyczne

Katowice, , Poland

Centrum Medyczne Plejady

Krakow, , Poland

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

Lublin, , Poland

Maxxmed Centrum Zdrowia i Urody w Lublinie

Lublin, , Poland

Gabinety Lekarskie Rivermed Sp. z o.o.

Poznan, , Poland

ETG Neuroscience Sp. z o.o.

Warsaw, , Poland

Hospital Universitario Cruces

Barakaldo, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

United States; Germany; Poland; Spain

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-001063-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-515177-94-00

Identifier Type: CTIS

Identifier Source: secondary_id

JZP385-202

Identifier Type: -

Identifier Source: org_study_id