Clinical trial NCT03877510: Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
Official title: An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson Disease
Keywords: motor fluctuations
IPX203
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 419
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and clinical utility of IPX203 in the treatment of participants with advanced Parkinson's disease (PD) who have motor fluctuations.

Detailed description: This is a 9-month, multicenter open-label safety extension study. Participants who have successfully completed Study NCT03670953 \[A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 with Immediate-Release (IR) Carbidopa-Levodopa (CD-LD) in Parkinson's Disease Patients with Motor Fluctuations\] may have the opportunity to enroll in this open-label study.

Eligibility criteria: Inclusion Criteria:

* Successfully completed Study IPX203-B16-02
* Able to provide written informed consent prior to the conduct of any study-specific procedures.
* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit (Visit 1).
* Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study.

Exclusion Criteria:

* Intends to use any doses of Rytary® or Duopa™ during this study.
* Plans to use an investigational treatment other than IPX203 during the course of this study.
* Neurosurgical ablation treatment for PD is planned or anticipated during the study period. Implantation of a deep brain stimulator (DBS) for the treatment of PD is permitted during this study.
* Participants who, in the opinion of the clinical investigator, should not participate in the study.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: From first dose up to 1 day after last dose (Up to 9 months/Early Termination [ET])
Secondary outcomes:
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Total
timeFrame: Baseline, Month 9/ET
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part I
timeFrame: Baseline, Month 9/ET
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part II
timeFrame: Baseline, Month 9/ET
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part III
timeFrame: Baseline, Month 9/ET
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Part IV
timeFrame: Baseline, Month 9/ET
measure: Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Sums of Part II and Part III
timeFrame: Baseline, Month 9/ET
measure: Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Patient Global Impression of Severity (PGI-S)
timeFrame: Baseline, Month 9/ET
measure: Percentage of Participants With a PGI-S ≥ 4 and PGI-S ≥ 5
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, Month 3, Month 6, Month 9/ET
measure: Change From Baseline in Clinical Global Impression of Severity (CGI-S)
timeFrame: Baseline, Month 9/ET
measure: Percentage of Participants With a CGI-S ≥ 4 and CGI-S ≥ 5
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: 39-item Parkinson's Disease Questionnaire (PDQ-39): Total
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in PDQ-39: Total
timeFrame: Baseline, Month 9/ET
measure: Parkinson Anxiety Scale (PAS): Total
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Parkinson Anxiety Scale (PAS): Total
timeFrame: Baseline, Month 9/ET
measure: Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Non-Motor Symptom Assessment Scale (NMSS) for Parkinson's Disease (PD): Total
timeFrame: Baseline, Month 9/ET
measure: Parkinson's Disease Sleep Scale-2 (PDSS-2) Total
timeFrame: Baseline, Month 3, Month 6, and Month 9/ET
measure: Change From Baseline in Parkinson's Disease Sleep Scale-2 (PDSS-2):Total
timeFrame: Baseline, Month 9/ET
measure: Treatment Satisfaction Assessment (TSA)
timeFrame: Month 3, Month 6 and Month 9/ET
measure: Percentage of Participants With TSA Scores 5-7 (Satisfied) Versus Scores 1-4 (Dissatisfied or Neutral)
timeFrame: Month 3, Month 6, and Month 9/ET
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc (102)
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156)
state: Arizona
city: Little Rock
country: United States
facility: Clinical Trials, Inc (113)
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (117)
state: Arkansas
city: Los Angeles
country: United States
facility: Keek School of Medicine of USC/ University of Southern California (106)
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian (134)
state: California
city: Pasadena
country: United States
facility: SC3 Research-Pasadena (148)
state: California
city: Reseda
country: United States
facility: SC3 Research-Reseda (146)
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital Anschutz Outpatient Pavilion (120)
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders (116)
state: Colorado
city: Newark
country: United States
facility: ChristianaCare Neurology Specialists (153)
state: Delaware
city: Atlantis
country: United States
facility: JEM Research Institute (136)
state: Florida
city: Aventura
country: United States
facility: Visionary Investigators Network (168)
state: Florida
city: Boca Raton
country: United States
facility: UHealth at Boca Raton (152)
state: Florida
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton (121)
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research LLC (104)
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Science Center (129)
state: Florida
city: Maitland
country: United States
facility: Neurology Associates, P.A. (125)
state: Florida
city: Miami
country: United States
facility: University of Miami (149)
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research Center, Inc. (163)
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of Southwest Florida (131)
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC (105)
state: Florida
city: Tampa
country: United States
facility: University of South Florida (114)
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute at Palm Beach Neurology (174)
state: Florida
city: Winter Park
country: United States
facility: Charter Research (166)
state: Florida
city: Atlanta
country: United States
facility: Emory Brain Health Center (110)
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net, LLC (155)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medical Group Neurology Clinic (145)
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital (151)
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Neuroscience Center(164)
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center (118)
state: Kansas
city: Farmington Hills
country: United States
facility: Quest Research Institute (103)
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital(100)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University (109)
state: Missouri
city: Las Vegas
country: United States
facility: Roseman Medical Research Institute / Roseman Medical Group (154)
state: Nevada
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health (142)
state: Nevada
city: Albany
country: United States
facility: Albany Medical College (139)
state: New York
city: Cincinnati
country: United States
facility: Ucgni (133)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center (123)
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic(144)
state: Ohio
city: Toledo
country: United States
facility: University of Toledo, Gardner-McMaster Parkinson Center (122)
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma (115)
state: Oklahoma
city: Nashville
country: United States
facility: The Vanderbilt Clinic (158)
state: Tennessee
city: Dallas
country: United States
facility: Neurology Consultants of Dallas, PA (108)
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center (143)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Neurological Institute/Movement Disorders Clinic (135)
state: Texas
city: Fairfax
country: United States
facility: Inova Neurology- Fairfax (147)
state: Virginia
city: Henrico
country: United States
facility: VCU Health- Neuroscience Orthopaedic and Wellness Center(124)
state: Virginia
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center (112)
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research (119)
state: Washington
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)
city: Choceň
country: Czechia
facility: NEUROHK. s.r.o. (701)
city: Pardubice
country: Czechia
facility: Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)
city: Praha 10
country: Czechia
facility: CLINTRIAL s.r.o. (703)
city: Praha 5
country: Czechia
facility: AXON Clinical. s.r.o. (700)
city: Praha 6
country: Czechia
facility: Neurologicka ordinace FORBELI s.r.o. (706)
city: Clermont-Ferrand Cedex 1
country: France
facility: CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404)
city: Montpellier Cedex 5
country: France
facility: CHU de Montpellier, Hopital Gui de Chauliac (405)
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice (400)
city: Toulouse Cedex 9
country: France
facility: Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403)
city: Beelitz-Heilstätten
country: Germany
facility: Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300)
state: Beelitz
city: Bochum
country: Germany
facility: St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301)
state: Gudrunstabe 56
city: München
country: Germany
facility: Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303)
state: Ismaningerstrabe
city: Berlin
country: Germany
facility: Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309)
city: Haag In Oberbayern
country: Germany
facility: Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305)
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306)
city: Cassino
country: Italy
facility: Centro Ricerca Parkinson San Raffaele Cassino (601)
state: Frosinone
city: Chieti
country: Italy
facility: Università G. D'annunzio CeSi Met (604)
state: Italy/Chieti/Abbruzzo
city: Pavia
country: Italy
facility: Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606)
state: Italy/Pavia/Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana (602)
state: Italy/Pisa/Toscana
city: Roma
country: Italy
facility: IRCCS San Raffaele Pi sana (600)
state: Italy/Roma/Lazio
city: Roma
country: Italy
facility: Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603)
state: Italy/Roma/Lazio
city: Roma
country: Italy
facility: University of Rome Tor Vergata/Hospital Tor Vergata (605)
state: Lazio
city: Catania
country: Italy
facility: Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608)
state: Sicily
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Neuromed (803)
city: Kraków
country: Poland
facility: Centrum Medyczne Linden (805)
city: Kraków
country: Poland
facility: Krakowska Akademia Neurologii Sp. Zo.o.(802)
city: Lublin
country: Poland
facility: NZOZ Neuromed M. i M. Nastaj Sp.p. (800)
city: Poznań
country: Poland
facility: NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)
city: Siemianowice Śląskie
country: Poland
facility: Neuro-Care Sp. z o.o. sp. k. (804)
city: Warszawa
country: Poland
facility: Centrum Medycme NeuroProtect (806)
city: Elche
country: Spain
facility: Hospital General Universitario de Elche (509)
state: Alicante
city: Sant Cugat Del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya (504)
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua Terrassa (506)
state: Barcelona
city: Donostia San Sebastian
country: Spain
facility: Policlinica Gipuzkoa, S.A (511)
state: Gipuzkoa
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra (512)
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Quiron Dexeus (501)
city: Barcelona
country: Spain
facility: Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron (505)
city: Barcelona
country: Spain
facility: Hospital de Ia Santa Creu i Sant Pau (502)
city: Madrid
country: Spain
facility: Hospital Universitario de Ia Princesa (508)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal (500)
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofia(513)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio (503)
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515)
city: Plymouth
country: United Kingdom
facility: Re:Cognition Health Ltd (205)
state: Devon
city: London
country: United Kingdom
facility: Imperial College Healthcare NI-lS Trust (200)
city: London
country: United Kingdom
facility: Re:Cognition Health Ltd (202)
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Impax Study Director
role: STUDY_DIRECTOR
References: