New drug targets stubborn tremors in Parkinson's

NCT ID NCT05642442

Symptom relief Sponsor: Jazz Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called suvecaltamide for people with Parkinson's disease who still have moderate to severe tremor despite taking other medications. Over 17 weeks, 169 participants received either the drug or a placebo, with doses adjusted for best effect. The goal was to see if the drug could reduce tremor and improve daily activities like eating and dressing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: suvecaltamide
What this could lead to: If it works, this could lead to a new option for controlling stubborn tremor in Parkinson's disease that standard medications don't fully manage.
What could go wrong: This is an early Phase 2 trial with only 169 people, so results may not apply broadly. The drug may not prove more effective than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

169 people

The number who actually took part.

Started

Dec 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

KEY 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). KEY 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. Other protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

movement disorder Parkinson disease Tremor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease Tremor

Contacts and locations

Locations

Albany Medical College

Albany, New York, 12208, United States
Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States
Centrum Medyczne Plejady

Krakow, 30-363, Poland
Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States
Columbia University Irving Medical Center

New York, New York, 10032, United States
Curiositas-ad-sanum Beratungs-und Studien GmbH

Haag in Oberbayern, 83527, Germany
Dent Neurologic Institute

Amherst, New York, 14226, United States
Deutsche Klinik fur Diagnostik Helios Klinik Wiesbaden

Hessen, 65191, Germany
ETG Neuroscience Sp. z o.o.

Warsaw, 02-777, Poland
EverGreenHealth Neuroscience Institute

Kirkland, Washington, 98034, United States
Gabinety Lekarskie Rivermed Sp. z o.o.

Poznan, 61-441, Poland
Hawaii Pacific Health

Honolulu, Hawaii, 96817, United States
Hospital Ramón y Cajal

Madrid, 28034, Spain
Hospital Universitario Cruces

Barakaldo, 48903, Spain
Hospital Universitario Virgen Macarena

Seville, 41009, Spain
Hospital Universitario de La Princesa

Madrid, 28006, Spain
Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain
Keck School of Medicine of University of Southern California (USC)

Los Angeles, California, 90033, United States
Maxxmed Centrum Zdrowia i Urody w Lublinie

Lublin, 20-080, Poland
Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States
NeuroTrials Research Inc.

Atlanta, Georgia, 30328, United States
Neurologia Slaska Centrum Medyczne

Katowice, 40-689, Poland
Neurology of Central Florida Research Center LLC

Altamonte Springs, Florida, 32714, United States
Niepubliczny Zaklad Opieki Zdrowotnej Neuromed M.i M. Nastaj Spólka Partnerska

Lublin, 20-064, Poland
Northwestern Medical Group, Department of Neurology

Chicago, Illinois, 60611, United States
Parkinson's Disease and Movement Disorder Center of Boca Raton

Boca Raton, Florida, 33486, United States
Pharmakologisches Studienzentrum Chemnitz GmbH

Chemnitz, 091111, Germany
South Shore Neurologic Associates PC

Patchogue, New York, 11772, United States
The Nene and Jamie Koch Comprehensive Movement Disorders Center

Albuquerque, New Mexico, 87106, United States
USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States
University of Cincinnati Gardner Neuroscience Institute (UCGNI)

Cincinnati, Ohio, 45219, United States
University of Colorado Hospital Anschutz Outpatient Pavilion

Aurora, Colorado, 80045, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Kentucky, College of Medicine, Department of Neurology

Lexington, Kentucky, 40536, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Velocity Clinical Research Germany GmbH, Location Wiesbaden

Wiesbaden, 65189, Germany
Zentrum f. klinische Forschung Dr. I. Schöll

Bad Homburg, 61350, Germany

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