Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor Fluctuations

An Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor Fluctuations

Sponsors

Lead Sponsor: Impax Laboratories, LLC

Source Impax Laboratories, LLC
Brief Summary

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

Detailed Description

This is a 9-month, multicenter open-label safety extension study. Subjects who have successfully completed Study IPX203-B16-02 [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.

Overall Status Enrolling by invitation
Start Date 2019-04-03
Completion Date 2022-02-28
Primary Completion Date 2022-01-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse Events Baseline through end of study up to 9 months
Secondary Outcome
Measure Time Frame
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Total Month 9
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part1 Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 1 Month 9
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 2 Month 9
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 3 Month 9
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Part 4 Month 9
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III Baseline
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) of Parts II and III Month 3
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III Month 6
Movement Disorders Society version of the Unified Parkinson's disease Rating Scale (MDS-UPDRS) Sum of Parts II and III Month 9
Treatment Satisfaction Assessment (TSA) Month 3
Treatment Satisfaction Assessment (TSA) Month 6
Treatment Satisfaction Assessment (TSA) Month 9
Patient Global Impression of Severity (PGI-S) Baseline
Patient Global Impression of Severity (PGI-S) Month 3
Patient Global Impression of Severity (PGI-S) Month 6
Patient Global Impression of Severity (PGI-S) Month 9
Clinical Global Impression of Severity (CGI-S) Baseline
Clinical Global Impression of Severity (CGI-S) Month 3
Clinical Global Impression of Severity (CGI-S) Month 6
Clinical Global Impression of Severity (CGI-S) Month 9
39-item Parkinson's disease questionnaire (PDQ-39) Baseline
39-item Parkinson's disease questionnaire (PDQ-39) Month 3
39-item Parkinson's disease questionnaire (PDQ-39) Month 6
39-item Parkinson's disease questionnaire (PDQ-39) Month 9
Parkinson Anxiety Scale (PAS) Baseline
Parkinson Anxiety Scale (PAS) Month 3
Parkinson Anxiety Scale (PAS) Month 6
Parkinson Anxiety Scale (PAS) Month 9
Non-motor symptom assessment scale for PD (NMSS) Baseline
Non-motor symptom assessment scale for PD (NMSS) Month 3
Non-motor symptom assessment scale for PD (NMSS) Month 6
Non-motor symptom assessment scale for PD (NMSS) Month 9
Parkinson's Disease Sleep Scale - 2 (PDSS-2) Baseline
Parkinson's Disease Sleep Scale - 2 (PDSS-2) Month 3
Parkinson's Disease Sleep Scale - 2 (PDSS-2) Month 6
Parkinson's Disease Sleep Scale - 2 (PDSS-2) Month 9
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: IPX203 140 mg

Description: 35 mg - 140 mg CD-LD extended release capsules

Arm Group Label: Open Label IPX203

Other Name: IPX203 35-140 mg

Intervention Type: Drug

Intervention Name: IPX203 210 mg

Description: 52.5 mg - 210 mg CD-LD extended release capsules

Arm Group Label: Open Label IPX203

Other Name: IPX203 52.5-210 mg

Intervention Type: Drug

Intervention Name: IPX203 280 mg

Description: 70 mg - 280 mg CD-LD extended release capsules

Arm Group Label: Open Label IPX203

Other Name: IPX203 70-280mg

Intervention Type: Drug

Intervention Name: IPX203 350 mg

Description: 87.5 mg - 350 mg CD-LD extended release capsules

Arm Group Label: Open Label IPX203

Other Name: IPX203 87.5-350mg

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 subjects 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. - Subjects who, in the opinion of the clinical investigator, should not participate in the study.

Gender:

All

Minimum Age:

40 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Impax Impax Study Director Study Director Impax Laboratories, LLC
Location
Facility:
Xenoscience, Inc (102) | Phoenix, Arizona, 85004, United States
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (156) | Phoenix, Arizona, 85013, United States
Clinical Trials, Inc (113) | Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences (117) | Little Rock, Arkansas, 72205, United States
Keek School of Medicine of USC/ University of Southern California (106) | Los Angeles, California, 90033, United States
Hoag Memorial Hospital Presbyterian (134) | Newport Beach, California, 92663, United States
SC3 Research-Pasadena (148) | Pasadena, California, 91105, United States
SC3 Research-Reseda (146) | Reseda, California, 91335, United States
University of Colorado Hospital Anschutz Outpatient Pavilion (120) | Aurora, Colorado, 80045, United States
Rocky Mountain Movement Disorders (116) | Englewood, Colorado, 80113, United States
ChristianaCare Neurology Specialists (153) | Newark, Delaware, 19713, United States
JEM Research Institute (136) | Atlantis, Florida, 33462, United States
Visionary Investigators Network (168) | Aventura, Florida, 33180, United States
UHealth at Boca Raton (152) | Boca Raton, Florida, 33431, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton (121) | Boca Raton, Florida, 33486, United States
Infinity Clinical Research LLC (104) | Hollywood, Florida, 33024, United States
University of Florida Health Science Center (129) | Jacksonville, Florida, 32209, United States
Neurology Associates, P.A. (125) | Maitland, Florida, 32751, United States
University of Miami (149) | Miami, Florida, 33136, United States
Medical Professional Clinical Research Center, Inc. (163) | Miami, Florida, 33165, United States
Parkinson's Disease Treatment Center of Southwest Florida (131) | Port Charlotte, Florida, 33980, United States
Infinity Clinical Research, LLC (105) | Sunrise, Florida, 33351, United States
University of South Florida (114) | Tampa, Florida, 33615, United States
Premiere Research Institute at Palm Beach Neurology (174) | West Palm Beach, Florida, 33407, United States
Charter Research (166) | Winter Park, Florida, 32792, United States
Emory Brain Health Center (110) | Atlanta, Georgia, 30329, United States
NeuroStudies.net, LLC (155) | Decatur, Georgia, 30033, United States
Northwestern Medical Group Neurology Clinic (145) | Chicago, Illinois, 60611, United States
Central DuPage Hospital (151) | Winfield, Illinois, 60190, United States
Indiana University Health Neuroscience Center(164) | Indianapolis, Indiana, 46202, United States
University of Kansas Medical Center (118) | Kansas City, Kansas, 66160, United States
Quest Research Institute (103) | Farmington Hills, Michigan, 48334, United States
Henry Ford West Bloomfield Hospital(100) | West Bloomfield, Michigan, 48322, United States
Washington University (109) | Saint Louis, Missouri, 63110, United States
Roseman Medical Research Institute / Roseman Medical Group (154) | Las Vegas, Nevada, 17601, United States
Cleveland Clinic Lou Ruvo Center for Brain Health (142) | Las Vegas, Nevada, 89106, United States
Albany Medical College (139) | Albany, New York, 12208, United States
Ucgni (133) | Cincinnati, Ohio, 45219, United States
University Hospitals Cleveland Medical Center (123) | Cleveland, Ohio, 44106, United States
Cleveland Clinic(144) | Cleveland, Ohio, 44195, United States
University of Toledo, Gardner-McMaster Parkinson Center (122) | Toledo, Ohio, 43614, United States
The Movement Disorder Clinic of Oklahoma (115) | Tulsa, Oklahoma, 74136, United States
The Vanderbilt Clinic (158) | Nashville, Tennessee, 37232, United States
Neurology Consultants of Dallas, PA (108) | Dallas, Texas, 75251, United States
University of Texas Southwestern Medical Center (143) | Dallas, Texas, 75390-9184, United States
Houston Methodist Neurological Institute/Movement Disorders Clinic (135) | Houston, Texas, 77030, United States
Inova Neurology- Fairfax (147) | Fairfax, Virginia, 17601, United States
VCU Health- Neuroscience Orthopaedic and Wellness Center(124) | Henrico, Virginia, 23233, United States
Booth Gardner Parkinson's Care Center (112) | Kirkland, Washington, 98034, United States
Inland Northwest Research (119) | Spokane, Washington, 99202, United States
Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704) | Brno, 65691, Czechia
NEUROHK. s.r.o. (701) | Choceň, 56501, Czechia
Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702) | Pardubice, 53203, Czechia
CLINTRIAL s.r.o. (703) | Praha 10, 10000, Czechia
AXON Clinical. s.r.o. (700) | Praha 5, 15000, Czechia
Neurologicka ordinace FORBELI s.r.o. (706) | Praha 6, 16000, Czechia
CHU de Clermont-Ferrand-Hopital Gabriel Montpied (404) | Clermont-Ferrand Cedex 1, 63003, France
CHU de Montpellier, Hopital Gui de Chauliac (405) | Montpellier Cedex 5, 34295, France
Centre Hospitalier Universitaire de Nice (400) | Nice, 06002, France
Centre d'lnvestigation Clinique 1436- CHU Purpan- Hopital Pierre Paul Riquet (403) | Toulouse Cedex 9, 31059, France
Kliniken Beelitz GmbH, neurologisches Fachkrankenhaus fur Bewegungsstorungen/Parkinson (300) | Beelitz-Heilstätten, Beelitz, 14547, Germany
St. Josef-Hospital, Universitatsklinik fur Neurologie Klinisches Forschungszentrum fur Neurodegeneration (301) | Bochum, Gudrunstabe 56, 44791, Germany
Klinikum rechts der lsar der Technischen Universitat Munchen Klinik und Poliklinik fur Neurologie (303) | München, Ismaningerstrabe, 81675, Germany
Dr. med. Reinhardt Ehret Neuroloqie Berlin Schlobstr. 29 (309) | Berlin, 12163, Germany
Klinik Haag i. OB Geriatric Hospital Krankenhausstrabe 4 (305) | Haag In Oberbayern, 83527, Germany
Gemeinschaftspraxis Dr. med. J. Springub/W. Schwarz, Studienzentrum Nordwest (306) | Westerstede, 26655, Germany
Centro Ricerca Parkinson San Raffaele Cassino (601) | Cassino, Frosinone, 03043, Italy
Università G. D'annunzio CeSi Met (604) | Chieti, Italy/Chieti/Abbruzzo, 66100, Italy
Fondazione I st ituto Neurologico Nazionale "C. Mondino" (606) | Pavia, Italy/Pavia/Lombardia, 27100, Italy
Azienda Ospedaliero-Universitaria Pisana (602) | Pisa, Italy/Pisa/Toscana, 56126, Italy
IRCCS San Raffaele Pi sana (600) | Roma, Italy/Roma/Lazio, 00163, Italy
Department of neuroscience, mental health and sensory system (NeSMOS), "Sapienza" University (603) | Roma, Italy/Roma/Lazio, 00189, Italy
University of Rome Tor Vergata/Hospital Tor Vergata (605) | Roma, Lazio, 00133, Italy
Department "G. F. Ingrassia" section of neuroscience - Policlinico "Vittorio Emanuele" (608) | Catania, Sicily, 95123, Italy
Centrum Medyczne Neuromed (803) | Bydgoszcz, 85163, Poland
Centrum Medyczne Linden (805) | Kraków, 30721, Poland
Krakowska Akademia Neurologii Sp. Zo.o.(802) | Kraków, 31-505, Poland
NZOZ Neuromed M. i M. Nastaj Sp.p. (800) | Lublin, 20-064, Poland
NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801) | Poznań, 61853, Poland
Neuro-Care Sp. z o.o. sp. k. (804) | Siemianowice Śląskie, 41100, Poland
Centrum Medycme NeuroProtect (806) | Warszawa, 01-684, Poland
Hospital General Universitario de Elche (509) | Elche, Alicante, 03203, Spain
Hospital Universitari General de Catalunya (504) | Sant Cugat Del Vallès, Barcelona, 08195, Spain
Hospital Universitari Mutua Terrassa (506) | Terrassa, Barcelona, 08222, Spain
Policlinica Gipuzkoa, S.A (511) | Donostia San Sebastian, Gipuzkoa, 20014, Spain
Clinica Universidad de Navarra (512) | Pamplona, Navarra, 31008, Spain
Hospital Universitario Quiron Dexeus (501) | Barcelona, 08028, Spain
Germanes Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516) | Barcelona, 08035, Spain
Hospital Universitario Vall d'Hebron (505) | Barcelona, 08035, Spain
Hospital de Ia Santa Creu i Sant Pau (502) | Barcelona, 08041, Spain
Hospital Universitario de Ia Princesa (508) | Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal (500) | Madrid, 28034, Spain
Hospital Universitario Infanta Sofia(513) | Madrid, 28703, Spain
Hospital Universitario Virgen del Rocio (503) | Sevilla, 41013, Spain
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell (515) | Valencia, 46026, Spain
Re:Cognition Health Ltd (205) | Plymouth, Devon, PL68BT, United Kingdom
Imperial College Healthcare NI-lS Trust (200) | London, W68RF, United Kingdom
Re:Cognition Health Ltd (202) | London, WlG9JF, United Kingdom
Location Countries

Czechia

France

Germany

Italy

Poland

Spain

United Kingdom

United States

Verification Date

2021-06-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Open Label IPX203

Type: Experimental

Description: Subjects will receive IPX203 140 mg, IPX203 210 mg, IPX203 280 mg, or IPX203 350 mg for approximately 9 months. The dose and dosing frequency will be determined by the investigator.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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