Evidence map›Paper›PMID 38111267›Full record

Trial reportMovement disorders : official journal of the Movement Disorder Society2024

Safety and Efficacy of IPX203 in Parkinson's Disease: The RISE-PD Open-Label Extension Study.

Alberto J Espay, Robert A Hauser, Rohit Dhall, Sandeep Thakkar, Leslie Cloud, Leonid Zeitlin, Ghazal Banisadr, Stanley Fisher, Hester Visser

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Movement disorders : official journal of the Movement Disorder Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Early clinical experience with IPX203 in Parkinson's disease with motor fluctuations.Journal of neural transmission (Vienna, Austria : 1996) · 2026
    Review
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Levodopa treatment: impacts and mechanisms throughout Parkinson's disease progression.Journal of neural transmission (Vienna, Austria : 1996) · 2025
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Alberto J EspayGardner Family Center for Parkinson's Disease and Movement Disorders, University of Cincinnati, Cincinnati, Ohio, USA.ORCID 0000-0002-3389-136X
Robert A HauserParkinson's Disease and Movement Disorders Center, University of South Florida, Tampa, Florida, USA.ORCID 0000-0002-6369-1203
Rohit DhallMovement Disorders Clinic, University of Arkansas for Medical Sciences, Little Rock, Alaska, USA.
Sandeep ThakkarDepartment of Neurology, Hoag Hospital Newport Beach, Newport Beach, California, USA.
Leslie CloudDepartment of Neurology, Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.
Leonid ZeitlinQuartesian LLC, Princeton, New Jersey, USA.
Ghazal BanisadrAmneal Pharmaceuticals, Bridgewater, New Jersey, USA.
Stanley FisherAmneal Pharmaceuticals, Bridgewater, New Jersey, USA.
Hester VisserAmneal Pharmaceuticals, Bridgewater, New Jersey, USA.

Funding

Expanding Translational Research in ArkansasUL1TR003107 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI JAMES, LAURA P · 2019 to 2023
$21.6M
SCH: Context-Aware Freezing of Gait Mitigation in Real-World SettingR01NS120560 · NINDS · VIRGINIA COMMONWEALTH UNIVERSITY · PI CLOUD, LESLIE J, PRETZER-ABOFF, INGRID A · 2021 to 2024
$1.2M
Psychogenic Tremor: Functional Magnetic Resonance Study on Emotional ProcessingK23MH092735 · NIMH · UNIVERSITY OF CINCINNATI · PI ESPAY, ALBERTO J · 2011 to 2015
$886k
NCATS NIH HHS UL1 TR003107NIMH NIH HHS K23 MH092735NINDS NIH HHS R01 NS120560
6 · The paper itself

Abstract

backgroundIPX203 is a novel oral extended-release formulation of carbidopa/levodopa (CD/LD) developed to address the short half-life of immediate-release CD/LD. In the phase 3 RISE-PD trial, IPX203 significantly improved "Good On" time in patients with Parkinson's disease compared with immediate-release CD/LD.

objectivesTo evaluate the safety and efficacy of IPX203 in an open-label extension of the pivotal phase 3 study.

methodsThis 9-month extension enrolled patients who completed the randomized, double-blind trial. Key efficacy endpoints included Movement Disorder Society-Unified Parkinson's Disease Rating Scale and Patient and Clinical Global Impression scores. Adverse events (AEs) were recorded.

resultsImprovements in efficacy were maintained and dosing frequency and total daily dose remained stable through the trial. A total of 52.7% of patients experienced ≥1 treatment-emergent AE, mostly mild or moderate and occurred within the first 90 days of treatment.

conclusionsIn this phase 3 open-label extension, IPX203 exhibited a favorable safety and tolerability profile and sustained efficacy of comparable magnitude to the end of the double-blind study. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Indexed as

Parkinson DiseaseAntiparkinson AgentsCarbidopaDelayed-Action PreparationsDouble-Blind MethodDrug CombinationsHumansLevodopaResearchAntiparkinson AgentsCarbidopaDelayed-Action PreparationsDrug CombinationsLevodopaextended releaselevodopamotor fluctuationsparkinson's diseases

Identifiers

PMID38111267
PMCPMC10922967

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.