Parkinson's Disease (Disorder) Clinical Trial
Official title:
A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations
| Verified date | September 2022 |
| Source | Impax Laboratories, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the safety and efficacy of IPX203 (carbidopa and levodopa) extended-release capsules (IPX203 ER CD-LD) in comparison to immediate release (IR) CD-LD in the treatment of CD-LD-experienced participants with Parkinson's disease (PD) who have motor fluctuations.
| Status | Completed |
| Enrollment | 630 |
| Est. completion date | June 15, 2021 |
| Est. primary completion date | June 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | Inclusion Criteria: - Male or female participants diagnosed at age = 40 years with PD, consistent with the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Criteria and who are being treated with stable regimens of CD-LD but experiencing motor fluctuations. - 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 Screening Visit. - Negative urine screen for drugs of abuse and negative alcohol breath test at Screening. - Hoehn and Yahr Stages 1, 2, 3, or 4 in the "On" state (part of Movement Disorders Society version of the Unified Parkinson's Disease Rating Scale [MDS-UPDRS] Part III) - Agrees to use a medically acceptable method of contraception throughout the study and for 6 weeks after completing the study. Medically acceptable methods of contraception that may be used by the participant and/or partner include but are not limited to: abstinence, oral contraception, NuvaRing or transdermal systems, diaphragm with vaginal spermicide, intrauterine device, condom and partner using vaginal spermicide, surgical sterilization (6 months), progestin implant or injection, or postmenopausal female (no menstrual period for ? 2 years) or vasectomy (? 6 months). - Montreal Cognitive Assessment (MoCA) score = 24 at Screening Visit in "On" state. - Able to differentiate "On" state from "Off" state as determined by at least 75% concordance with a trained rater in "On/Off" ratings for 8 ratings over a 4-hour training period. The concordance must include at least 1 "On" and 1 "Off" rating and must be achieved within two 4-hour training sessions. - Able and willing to comply with the protocol, including completion of diaries and availability for all study visits. - Responsive to CD-LD therapy and currently being treated on a stable regimen with CD-LD for at least 4 weeks prior to Visit 1. - At Screening, the participant has predictable "Off" periods. Exclusion Criteria: - Received any investigational medications within 30 days or 5 times the half-life, whichever is longer, prior to Visit 1. - Female participants who are currently breastfeeding or lactating. - Had prior neurosurgical treatment for PD or if such procedure is planned or anticipated during the study period. - Allergic to any excipient in the study drugs. - History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy, proximal small-bowel resection, or bariatric surgery. - History of upper gastrointestinal hemorrhage in participants with peptic ulcer disease within the past 5 years. - History of glaucoma with intraocular pressures that are elevated despite appropriate medical management. - History of seizure or epilepsy and experienced at least 1 seizure during the past 12 months or has not been compliant with medically recommended therapy or visits. - History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias that are not controlled with medical and/or surgical interventions. A recent (= 12 months) history of myocardial infarction with secondary arrhythmias is exclusionary regardless of the therapeutic control. - History of neuroleptic malignant syndrome or of nontraumatic rhabdomyolysis. - Liver enzyme values = 2.5 times the upper limit of normal; or history of severe hepatic impairment. - Serum creatinine level = 1.75 times the upper limit of normal; or requires dialysis at the time of Screening. - Participant with a history of malignant melanoma or with a suspicious undiagnosed skin lesion which in the opinion of the investigator could be melanoma. - History of drug or alcohol abuse within the 12 months prior to Screening. - Received within 4 weeks of Screening or planning to take during participation in the clinical study: - Any doses of a CR CD-LD apart from a single daily bedtime dose, any doses of Rytary, additional CD (eg, Lodosyn) or benserazide (eg, Serazide), or catechol-O-methyl transferase inhibitors (entacapone or tolcapone) or medications containing these inhibitors (Stalevo), - Nonselective monoamine oxidase inhibitors (MAOI), apomorphine, or antidopaminergic agents, including antiemetics. - Employees or family members of the investigator, study site, or sponsor. - Participants who have previously participated in an IPX203 study. - Participants who, in the opinion of the clinical investigator, should not participate in the study. - Based on clinical assessment, participant does not adequately comprehend the terminology needed to complete the PD diary. |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704) | Brno | |
| Czechia | Neurohk, s.r.o (701) | Chocen | |
| Czechia | Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702) | Pardubice | |
| Czechia | Clintrial s.r.o. (703) | Praha 10 | |
| Czechia | AXON Clinical, s.r.o. (700) | Praha 5 | |
| Czechia | Neurologicka ordinace FORBELI s.r.o.(706) | Praha 6 | |
| France | CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404) | Clermont-Ferrand Cedex 1 | |
| France | CHU de Montpellier, Hopital Gui de Chauliac(405) | Montpellier Cedex 5 | |
| France | Centre Hospitalier Universitaire de Nice (400) | Nice | |
| France | INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402) | Poitiers Cedex | |
| France | Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403) | Toulouse Cedex 9 | |
| Germany | Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300) | Beelitz-Heilstatten | Brandenburg |
| Germany | Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309) | Berlin | |
| Germany | St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301) | Bochum | North Rhine-Westphalia |
| Germany | Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307) | Dresden | Saxony |
| Germany | Klinik Haag i. OB, Geriatric Hospital (305) | Haag In Oberbayern | Oberbayern (Upper Bavaria) |
| Germany | Curiositas ad sanum, Studien und Beratungs GmbH(311) | München | Bavaria |
| Germany | Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303) | München | Bavaria |
| Germany | Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306) | Westerstede | Lower Saxony |
| Italy | Centro Ricerca Parkinson San Raffaele Cassino (601) | Cassino | Italy/Frosinone/Lazio |
| Italy | Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608) | Catania | Italy/Catania/Sicily |
| Italy | Universita G. D'annunzio CeSi Met (604) | Chieti | Italy/Chieti/Abbruzzo |
| Italy | Fondazione lstituto Neurologico Nazionale "C. Mondino" (606) | Pavia | Italy/Pavia/Lombardia |
| Italy | Azienda Ospedaliero-Universitaria Pisana (602) | Pisa | Italy/Pisa/Toscana |
| Italy | Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603) | Roma | Italy/Roma/Lazio |
| Italy | IRCCS San Raffaele Pisana (600) | Roma | Italy/Roma/Lazio |
| Italy | University of Rome Tor Vergata/Hospital Tor Vergata (605) | Roma | Italy/Roma/Lazio |
| Poland | Centrum Medyczne Neuromed (803) | Bydgoszcz | |
| Poland | Krakowska Akademia Neurologii Sp. z o.o.(802) | Kraków | |
| Poland | Szpital Sw. Rozy (805) | Kraków | |
| Poland | NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800) | Lublin | |
| Poland | NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801) | Poznan | |
| Poland | Neuro-Care Sp. z o.o. sp. k.(804) | Siemianowice Slaskie | |
| Poland | Centrum Medyczne NeuroProtect (806) | Warszawa | |
| Spain | Hospital Clinic de Barcelona (507) | Barcelona | |
| Spain | Hospital De La Santa Creu i Sant Pau (502) | Barcelona | |
| Spain | Hospital Universitario Quiron Dexeus (501) | Barcelona | |
| Spain | Hospital Universitario Vall d' Hebron (505) | Barcelona | |
| Spain | Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516) | Barcelona | |
| Spain | Hospital Genral Universitario de Elche (509) | Elche | Alicante |
| Spain | Hospital Universitario de la Princesa (508) | Madrid | |
| Spain | Hospital Universitario Infanta Sofia (513) | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal (500) | Madrid | |
| Spain | Clinica Universidad de Navarra (512) | Pamplona | Navarra |
| Spain | Policlinica Gipuzkoa, S.A.,(511) | San Sebastian | Gipuzkoa |
| Spain | Hospital Universitari General de Catalunya (504) | Sant Cugat Del Vallès | Barcelona |
| Spain | Hospital Universitario Virgen del Rocio (503) | Sevilla | |
| Spain | Hospital Universitari Mutua Terrassa (506) | Terrassa | Barcelona |
| Spain | Hospital Universitario y politecnico La Fe (515) | Valencia | |
| United Kingdom | Imperial College Healthcare NHS Trust (200) | London | |
| United Kingdom | Re:Cognition Health Ltd (202) | London | |
| United Kingdom | Re: Cognition Health Ltd(205) | Plymouth | Devon |
| United States | Albany Medical College (139) | Albany | New York |
| United States | Inova Medical Group-Neurology I (147) | Alexandria | Virginia |
| United States | Emory Brain Health Center (110) | Atlanta | Georgia |
| United States | JEM Research Institute (136) | Atlantis | Florida |
| United States | University of Colorado Hospital Anschutz Outpatient Pavilion (120) | Aurora | Colorado |
| United States | Visionary Investigators Network (168) | Aventura | Florida |
| United States | Parkinson's Disease and Movement Disorders Center of Boca Raton (121) | Boca Raton | Florida |
| United States | University of Miami-UHealth at Boca Raton (152) | Boca Raton | Florida |
| United States | Medical University of South Carolina (150) | Charleston | South Carolina |
| United States | Northwestern Medical Group Neurology Clinic(145) | Chicago | Illinois |
| United States | Ucgni (133) | Cincinnati | Ohio |
| United States | Cleveland Clinic (144) | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center (123) | Cleveland | Ohio |
| United States | Neurology Consultants of Dallas, PA (108) | Dallas | Texas |
| United States | University of Texas Southwestern Medical Center (143) | Dallas | Texas |
| United States | NeuroStudies.net, LLC (155) | Decatur | Georgia |
| United States | Rocky Mountain Movement Disorders Center (116) | Englewood | Colorado |
| United States | Quest Research Institute (103) | Farmington Hills | Michigan |
| United States | Struthers Parkinson's Center (130) | Golden Valley | Minnesota |
| United States | MD Clinical (111) | Hallandale Beach | Florida |
| United States | VCU Health - Neuroscience, Orthopaedic and Wellness Center (124) | Henrico | Virginia |
| United States | Infinity Clinical Research (104) | Hollywood | Florida |
| United States | Houston Methodist Neurological Institute/Movement Disorders Clinic (135) | Houston | Texas |
| United States | Indiana University Health Neuroscience Center (164) | Indianapolis | Indiana |
| United States | University of Florida Health Science Center(129) | Jacksonville | Florida |
| United States | University of Kansas Medical Center (118) | Kansas City | Kansas |
| United States | Booth Gardner Parkinson's Care Center (112) | Kirkland | Washington |
| United States | Cleveland Clinic Lou Ruvo Center for Brain Health (142) | Las Vegas | Nevada |
| United States | Roseman Medical Research Institute/Roseman Medical Group (154) | Las Vegas | Nevada |
| United States | Clinical Trials, Inc. (113) | Little Rock | Arkansas |
| United States | University of Arkansas for Medical Sciences (117) | Little Rock | Arkansas |
| United States | Loma Linda University Health Care, Department of Neurology (137) | Loma Linda | California |
| United States | Keck School of Medicine of USC/University of Southern California (106) | Los Angeles | California |
| United States | Neurology Associates, P.A. (125) | Maitland | Florida |
| United States | Medical Professional Clinical Research Center, INC (163) | Miami | Florida |
| United States | University of Miami (149) | Miami | Florida |
| United States | The Vanderbilt Clinic(158) | Nashville | Tennessee |
| United States | Mount Sinai West-Department of Neurology(172) | New York | New York |
| United States | Christiana Care Neurology Specialists (153) | Newark | Delaware |
| United States | Hoag Memorial Hospital Presbyterian (134) | Newport Beach | California |
| United States | SC3 Research - Pasadena (148) | Pasadena | California |
| United States | St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156) | Phoenix | Arizona |
| United States | Xenoscience, Inc. (102) | Phoenix | Arizona |
| United States | Parkinsons's Disease Treatment Center of Southwest Florida (131) | Port Charlotte | Florida |
| United States | SC3 Research - Reseda (146) | Reseda | California |
| United States | Washington University (109) | Saint Louis | Missouri |
| United States | Inland Northwest Research (119) | Spokane | Washington |
| United States | Infinity Clinical Research, LLC (105) | Sunrise | Florida |
| United States | University of South Florida (114) | Tampa | Florida |
| United States | University of Toledo, Gardner-McMaster Parkinson Center (122) | Toledo | Ohio |
| United States | Movement Disorder Clinic of Oklahoma (115) | Tulsa | Oklahoma |
| United States | Henry Ford West Bloomfield Hospital (100) | West Bloomfield | Michigan |
| United States | Premiere Research Institute at Palm Beach Neurology (174) | West Palm Beach | Florida |
| United States | Central DuPage Hospital (151) | Winfield | Illinois |
| United States | Wake Forest Baptist Health Sciences (127) | Winston-Salem | North Carolina |
| United States | Charter Research (166) | Winter Park | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Impax Laboratories, LLC |
United States, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET) | "Good on" time was derived from the 3-day PD Diaries. For each day, "Good on" time was calculated by adding the number of half-hour intervals in which either an "On" without dyskinesia or "On" with nontroublesome dyskinesia was checked.
Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. Least square mean (LSM), standard error (SE), confidence interval (CI), Mixed model repeated measures (MMRM), Change from baseline (CFB). |
Baseline (Week 7) and Week 20/ET | |
| Secondary | Change From Baseline in "Off" Time Per Day at Week 20/ET | "Off" time was derived from the 3-day PD Diaries. For each day, "Off" time was calculated by adding the number of half-hour intervals in which the Status "Off" was checked. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. | Baseline (Week 7) and Week 20/ET | |
| Secondary | Percentage of Participants With Either "Much Improved" or "Very Much Improved" in Patient Global Impression of Change (PGI-C) Scores at Week 20/ET | The Patient Global Impression of Change (PGIC) is self assessment questionnaire which was used by participants to compare his/her condition on a 7-point scale ranging from 1-Very Much Worse, 2-Much Worse, 3-Minimally Worse, 4-No Change, 5-Minimally Improved, 6-Much Improved, 7-Very Much Improved. Percentage of participants with either "Much Improved" or "Very Much Improved" was reported. | Week 20/ET | |
| Secondary | Change From Baseline in The Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at Week 20/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). Part III score ranges from 0 to 136. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. | Baseline (Week 7) and Week 20/ET | |
| Secondary | Change From Baseline in The Sum of MDS-UPDRS Part II and Part III at Week 20/ET | MDS-UPDRS is a multimodal scale assessing impairment and disability consisting of 4 parts. (Part I; 13 items) non-motor experiences of daily living, (Part II; 13 items) motor experiences of daily living completed by the participants, (Part III; 34 items) motor examination of PD and was administered by the rater, and (Part IV; 6 items) motor complication integrates participant-derived information with the rater's clinical observations and judgements and is completed by the rater. For each question a numeric score was assigned between 0-4, where 0 = Normal, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = Severe. MDS-UPDRS Total Score equals the sum of Parts I, II, and III and IV (Range 0-234). The scale range for Part II+III score is 0-188. A higher score indicated more severe symptoms of PD. Baseline was defined as data obtained from PD Diary collected over 3 days prior to Week 7/Randomization. | Baseline (Week 7) and Week 20/ET |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04608123 -
Effect of Deep Brain Stimulation on Neuropsychiatric Fluctuations in Patients With Parkinson's Disease
|