AzTrials
AzTrials

Parkinson's Disease (Disorder)Phase 3NCT03670953

A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations

A Phase 3 study testing IR CD-LD and IPX203 ER CD-LD in people with Parkinson's Disease (Disorder), run by Impax Laboratories, LLC at 108 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Parkinson's Disease (Disorder)
What is being tested?
IR CD-LD and IPX203 ER CD-LD
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
630 participants
Where
108 sitesin 8 countries
Study dates
6 Nov 2018to 15 Jun 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 21Show fewer
  • 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.

Trial locations and contacts

108 sites in 8 countries.

108 sites in 8 countries

United States56 sites

  • Albany Medical College (139)

    Albany, New York, 12208

  • Inova Medical Group-Neurology I (147)

    Alexandria, Virginia, 22311

  • Emory Brain Health Center (110)

    Atlanta, Georgia, 30329

  • JEM Research Institute (136)

    Atlantis, Florida, 33462

  • University of Colorado Hospital Anschutz Outpatient Pavilion (120)

    Aurora, Colorado, 80045

  • Visionary Investigators Network (168)

    Aventura, Florida, 33180

  • University of Miami-UHealth at Boca Raton (152)

    Boca Raton, Florida, 33131

  • Parkinson's Disease and Movement Disorders Center of Boca Raton (121)

    Boca Raton, Florida, 33486

  • Medical University of South Carolina (150)

    Charleston, South Carolina, 29425

  • Northwestern Medical Group Neurology Clinic(145)

    Chicago, Illinois, 60611

  • Ucgni (133)

    Cincinnati, Ohio, 45219

  • University Hospitals Cleveland Medical Center (123)

    Cleveland, Ohio, 44106

  • Cleveland Clinic (144)

    Cleveland, Ohio, 44195

  • Neurology Consultants of Dallas, PA (108)

    Dallas, Texas, 75251

  • University of Texas Southwestern Medical Center (143)

    Dallas, Texas, 75390-9184

  • NeuroStudies.net, LLC (155)

    Decatur, Georgia, 30033

  • Rocky Mountain Movement Disorders Center (116)

    Englewood, Colorado, 80113

  • Quest Research Institute (103)

    Farmington Hills, Michigan, 48334

  • Struthers Parkinson's Center (130)

    Golden Valley, Minnesota, 55427

  • MD Clinical (111)

    Hallandale, Florida, 33009

  • VCU Health - Neuroscience, Orthopaedic and Wellness Center (124)

    Henrico, Virginia, 23233

  • Infinity Clinical Research (104)

    Hollywood, Florida, 33024

  • Houston Methodist Neurological Institute/Movement Disorders Clinic (135)

    Houston, Texas, 77030

  • Indiana University Health Neuroscience Center (164)

    Indianapolis, Indiana, 46202

  • University of Florida Health Science Center(129)

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center (118)

    Kansas City, Kansas, 66160

  • Booth Gardner Parkinson's Care Center (112)

    Kirkland, Washington, 98034

  • Cleveland Clinic Lou Ruvo Center for Brain Health (142)

    Las Vegas, Nevada, 89106

  • Roseman Medical Research Institute/Roseman Medical Group (154)

    Las Vegas, Nevada, 89118

  • Clinical Trials, Inc. (113)

    Little Rock, Arkansas, 72205

  • University of Arkansas for Medical Sciences (117)

    Little Rock, Arkansas, 72205

  • Loma Linda University Health Care, Department of Neurology (137)

    Loma Linda, California, 92354

  • Keck School of Medicine of USC/University of Southern California (106)

    Los Angeles, California, 90033

  • Neurology Associates, P.A. (125)

    Maitland, Florida, 32751

  • University of Miami (149)

    Miami, Florida, 33136

  • Medical Professional Clinical Research Center, INC (163)

    Miami, Florida, 33165

  • The Vanderbilt Clinic(158)

    Nashville, Tennessee, 37232

  • Mount Sinai West-Department of Neurology(172)

    New York, New York, 10019

  • Christiana Care Neurology Specialists (153)

    Newark, Delaware, 19713

  • Hoag Memorial Hospital Presbyterian (134)

    Newport Beach, California, 92663

  • SC3 Research - Pasadena (148)

    Pasadena, California, 91105

  • Xenoscience, Inc. (102)

    Phoenix, Arizona, 85004

  • St. Joseph's Hospital & Medical Center/ Barrow Neurological Institute (156)

    Phoenix, Arizona, 85013

  • Parkinsons's Disease Treatment Center of Southwest Florida (131)

    Port Charlotte, Florida, 33980

  • SC3 Research - Reseda (146)

    Reseda, California, 91335

  • Inland Northwest Research (119)

    Spokane, Washington, 99202

  • Washington University (109)

    St Louis, Missouri, 63110

  • Infinity Clinical Research, LLC (105)

    Sunrise, Florida, 33351

  • University of South Florida (114)

    Tampa, Florida, 33613

  • University of Toledo, Gardner-McMaster Parkinson Center (122)

    Toledo, Ohio, 43614

  • Movement Disorder Clinic of Oklahoma (115)

    Tulsa, Oklahoma, 74136

  • Henry Ford West Bloomfield Hospital (100)

    West Bloomfield, Michigan, 483222

  • Premiere Research Institute at Palm Beach Neurology (174)

    West Palm Beach, Florida, 33407

  • Central DuPage Hospital (151)

    Winfield, Illinois, 60190

  • Wake Forest Baptist Health Sciences (127)

    Winston-Salem, North Carolina, 27157

  • Charter Research (166)

    Winter Park, Florida, 32792

Other trials in United States

Spain15 sites

  • Hospital Universitario Quiron Dexeus (501)

    Barcelona, 08028

  • Hospital Universitario Vall d' Hebron (505)

    Barcelona, 08035

  • Hospitalaries Del Sagrat Cor De Jesus Hospital Sant Rafael (516)

    Barcelona, 08035

  • Hospital Clinic de Barcelona (507)

    Barcelona, 08036

  • Hospital De La Santa Creu i Sant Pau (502)

    Barcelona, 08041

  • Policlinica Gipuzkoa, S.A.,(511)

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital Genral Universitario de Elche (509)

    Elche, Alicante, 03203

  • Hospital Universitario de la Princesa (508)

    Madrid, 28006

  • Hospital Universitario Ramon y Cajal (500)

    Madrid, 28034

  • Hospital Universitario Infanta Sofia (513)

    Madrid, 28703

  • Clinica Universidad de Navarra (512)

    Pamplona, Navarre, 31008

  • Hospital Universitari General de Catalunya (504)

    Sant Cugat del Vallès, Barcelona, 08190

  • Hospital Universitario Virgen del Rocio (503)

    Seville, 41013

  • Hospital Universitari Mutua Terrassa (506)

    Terrassa, Barcelona, 08222

  • Hospital Universitario y politecnico La Fe (515)

    Valencia, 46026

Other trials in Spain

Germany8 sites

  • Kliniken Beelitz GmbH, Neurologisches Fachkrankenhaus fUr Bewegungsstorungen/Parkinson (300)

    Beelitz-Heilstätten, Brandenburg, 14547

  • Dr. med. REINHARDT Ehret Neurologie Berlin Schlobstr. 29 (309)

    Berlin, 12163

  • St. Josef-Hospital, Universitatsklinik fur Neurologie, Klinisches Forschungszentrum fur Neurodegeneration (301)

    Bochum, North Rhine-Westphalia, 44791

  • Universitatsklinikum Carl Gustav Carus, Klinik und Poliklinik fur Neurologie (307)

    Dresden, Saxony, 01307

  • Klinik Haag i. OB, Geriatric Hospital (305)

    Haag in Oberbayern, Oberbayern (Upper Bavaria), 83527

  • Curiositas ad sanum, Studien und Beratungs GmbH(311)

    München, Bavaria, 80331

  • Klinikum rechts der lsar der TUM, Klinik und Poliklinik fur Neurologie (303)

    München, Bavaria, 81675

  • Gemeinschaftspraxis Dr. med. Joachim Springub/ Wolfgang Schwarz, Studienzentrum Nord-West (306)

    Westerstede, Lower Saxony, 26655

Other trials in Germany

Italy8 sites

  • Centro Ricerca Parkinson San Raffaele Cassino (601)

    Cassino, Italy/Frosinone/Lazio, 03043

  • Department "G.F. Ingrassia" Section of neuroscience-Policlinico "Vittorio Emanuele" (608)

    Catania, Italy/Catania/Sicily, 95123

  • Universita G. D'annunzio CeSi Met (604)

    Chieti, Italy/Chieti/Abbruzzo, 66100

  • Fondazione lstituto Neurologico Nazionale "C. Mondino" (606)

    Pavia, Italy/Pavia/Lombardia, 27100

  • Azienda Ospedaliero-Universitaria Pisana (602)

    Pisa, Italy/Pisa/Toscana, 56126

  • University of Rome Tor Vergata/Hospital Tor Vergata (605)

    Roma, Italy/Roma/Lazio, 00133

  • IRCCS San Raffaele Pisana (600)

    Roma, Italy/Roma/Lazio, 00163

  • Department of Neuroscience, Mental Health and Sensory System (NeSMOS), Sapienza University (603)

    Roma, Italy/Roma/Lazio, 00189

Other trials in Italy

Poland7 sites

  • Centrum Medyczne Neuromed (803)

    Bydgoszcz, 85-163

  • Szpital Sw. Rozy (805)

    Krakow, 30-394

  • Krakowska Akademia Neurologii Sp. z o.o.(802)

    Krakow, 31-505

  • NZOZ Neuromed M. i M Nastaj Spolka Partnerska(800)

    Lublin, 20-064

  • NZOZ Neuro-Kard Ilkowski i Partnerzy Spolka Partnerska Lekarzy (801)

    Poznan, 61-853

  • Neuro-Care Sp. z o.o. sp. k.(804)

    Siemianowice Śląskie, 41-100

  • Centrum Medyczne NeuroProtect (806)

    Warsaw, 01-684

Other trials in Poland

Czechia6 sites

  • Fakultni nemocnice u sv. Anny v Brne, I. neurologicka klinika (704)

    Brno, 65691

  • Neurohk, s.r.o (701)

    Choceň, 56501

  • Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice, Neurologicka klinika (702)

    Pardubice, 53203

  • Clintrial s.r.o. (703)

    Prague, 10000

  • AXON Clinical, s.r.o. (700)

    Prague, 15000

  • Neurologicka ordinace FORBELI s.r.o.(706)

    Prague, 160 00

Other trials in Czechia

France5 sites

  • CHU de Clermont-Ferrand - Hopital Gabriel Montpied (404)

    Clermont-Ferrand, 63003

  • CHU de Montpellier, Hopital Gui de Chauliac(405)

    Montpellier, 34295

  • Centre Hospitalier Universitaire de Nice (400)

    Nice, 06002

  • INSERM, Centre d'investigation Clinique 1402, CHU de Poitiers (402)

    Poitiers, 86021

  • Centre d'Investigation Clinique 1436-CHU Purpan-Hopital Pierre Paul Riquet (403)

    Toulouse, 31059

Other trials in France

United Kingdom3 sites

  • Re:Cognition Health Ltd (202)

    London, W1G9JF

  • Imperial College Healthcare NHS Trust (200)

    London, W68RF

  • Re: Cognition Health Ltd(205)

    Plymouth, Devon, PL68BT

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

This was a multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study. The study consisted of a 3-week, open-label IR CD-LD dose adjustment period; a 4-week, open-label period for conversion to IPX203; followed by a 13-week double-blind treatment period with participants randomized in a 1:1 ratio, stratified by center, to receive either IPX203 (with matching IR CD-LD placebo) or IR CD-LD (with matching IPX203 placebo).

Being tested
IR CD-LD, IPX203 ER CD-LD, Placebo Matching IPX203, Placebo Matching IR CD-LD
Keywords
Idiopathic Parkinson's Disease, Lewy Body Parkinson's Disease, Paralysis Agitans, Primary Parkinsonism
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IR CD-LDDrug

    Also called Generic for Sinemet tablets

    Active comparator - IR CD-LD

  • IPX203 ER CD-LDDrug

    Investigational formulation - ER CD-LD

  • Placebo Matching IPX203Other

    Double dummy placebo capsules

  • Placebo Matching IR CD-LDOther

    Double dummy placebo tablets

Study groups in NCT03670953
Study groupRoleWhat they receive
IR CD-LD - Dose AdjustmentActive comparatorParticipants started on the same dose as the pre-study dosing regimen of IR CD-LD and then received dose adjusted IR CD-LD tablets daily orally, for a period of 3 weeks. If the participant was taking controlled release carbidopa-levodopa (CR CD-LD), the CR CD-LD was discontinued and substituted with a 1:1 milligram-equivalent dose of IR CD-LD.
Receives: Drug: IR CD-LD
IPX203 - Dose ConversionExperimentalParticipants received extended release (ER) CD-LD (IPX203) capsules orally, every 6 - 12 hours for a period of 4 weeks at a dose based on their most frequent stable dose of IR CD-LD in dose adjustment period. Participant with most frequent stable dose of 25-100 milligrams (mg) IR CD-LD received 70 - 280 mg IPX203 thrice daily (TID); >25-100 - 37.5-150 mg IR CD-LD received 105-420 mg IPX203 TID; >37.5-150 - 50-200 mg IR CD-LD received 140-560 mg IPX203 TID; >50 - 200 mg IR CD-LD received 175-700 mg IPX203 TID. Participants who received a daily total dose of less than 125-500 mg IR CD-LD in dose adjustment received IPX203 every 12 hours. After initial dose conversion from IR CD-LD to IPX203 as per above mentioned dose conversion schedule, the dose of IPX203 could be further adjusted during the 4 week dose conversion period.
Receives: Drug: IPX203 ER CD-LD
IPX203 - Double-Blind MaintenanceExperimentalParticipants received IPX203 capsules orally, every 6 - 12 hours for 13 weeks at a stable dose established at the end of dose conversion period along with placebo matched to IR CD-LD.
Receives: Drug: IPX203 ER CD-LD; Other: Placebo Matching IPX203
IR CD-LD - Double -Blind MaintenanceActive comparatorParticipants received IR CD-LD tablets daily orally, for 13 weeks at a stable dose established at the end of dose adjustment period along with placebo matched to IPX203.
Receives: Drug: IR CD-LD; Other: Placebo Matching IR CD-LD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline (Week 7) and Week 20/ET

Secondary outcomes (4)

  1. 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.

    Measured: Baseline (Week 7) and Week 20/ET

  2. 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.

    Measured: Week 20/ET

  3. 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.

    Measured: Baseline (Week 7) and Week 20/ET

  4. 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.

    Measured: Baseline (Week 7) and Week 20/ET

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start6 Nov 2018
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
630 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03670953
Sponsor's protocol ID
IPX203-B16-02
Other IDs
2018-002233-37, 2018
Status last verified
Sep 2022
First submitted
12 Sep 2018
Last updated
9 Feb 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hauser RA, Espay AJ, Ellenbogen AL, Fernandez HH, Isaacson SH, LeWitt PA, Ondo WG, Pahwa R, Schwarz J, Stocchi F, Zeitlin L, Banisadr G, Fisher S, Visser H, D'Souza R. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. doi: 10.1001/jamaneurol.2023.2679.

    PubMed 37578800

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IR CD-LD and IPX203 ER CD-LD in people with Parkinson's Disease (Disorder), run by Impax Laboratories, LLC at 108 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Spain, Germany, Italy, Poland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change From Baseline in "Good on" Time Per Day at Week 20/Early Termination (ET) (time frame: Baseline (Week 7) and Week 20/ET). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03670953, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in