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

PHASE2CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

October 23, 2024

Study Completion Date

November 11, 2024

Conditions
Parkinson DiseaseTremor
Interventions
DRUG

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.

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.

Trial Locations (37)

10032

Columbia University Irving Medical Center, New York

11772

South Shore Neurologic Associates PC, Patchogue

12208

Albany Medical College, Albany

14226

Dent Neurologic Institute, Amherst

28006

Hospital Universitario de La Princesa, Madrid

28034

Hospital Ramón y Cajal, Madrid

30328

NeuroTrials Research Inc., Atlanta

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32714

Neurology of Central Florida Research Center LLC, Altamonte Springs

33486

Parkinson's Disease and Movement Disorder Center of Boca Raton, Boca Raton

33613

USF Parkinson's Disease and Movement Disorders Center, Tampa

37232

Vanderbilt University Medical Center, Nashville

40536

University of Kentucky, College of Medicine, Department of Neurology, Lexington

41009

Hospital Universitario Virgen Macarena, Seville

45219

University of Cincinnati Gardner Neuroscience Institute (UCGNI), Cincinnati

48903

Hospital Universitario Cruces, Barakaldo

60611

Northwestern Medical Group, Department of Neurology, Chicago

61350

Zentrum f. klinische Forschung Dr. I. Schöll, Bad Homburg

65189

Velocity Clinical Research Germany GmbH, Location Wiesbaden, Wiesbaden

65191

Deutsche Klinik fur Diagnostik Helios Klinik Wiesbaden, Hessen

66160

University of Kansas Medical Center, Kansas City

78681

Central Texas Neurology Consultants, Round Rock

80045

University of Colorado Hospital Anschutz Outpatient Pavilion, Aurora

83527

Curiositas-ad-sanum Beratungs-und Studien GmbH, Haag in Oberbayern

85258

Movement Disorders Center of Arizona, Scottsdale

87106

The Nene and Jamie Koch Comprehensive Movement Disorders Center, Albuquerque

90033

Keck School of Medicine of University of Southern California (USC), Los Angeles

96817

Hawaii Pacific Health, Honolulu

98034

EverGreenHealth Neuroscience Institute, Kirkland

091111

Pharmakologisches Studienzentrum Chemnitz GmbH, Chemnitz

40-689

Neurologia Slaska Centrum Medyczne, Katowice

30-363

Centrum Medyczne Plejady, Krakow

20-064

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

20-080

Maxxmed Centrum Zdrowia i Urody w Lublinie, Lublin

61-441

Gabinety Lekarskie Rivermed Sp. z o.o., Poznan

02-777

ETG Neuroscience Sp. z o.o., Warsaw

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY