Evidence map›Paper›PMID 26632091›Full record

Trial reportJournal of clinical pharmacology2016

Dose-Response Analysis of the Effect of Carbidopa-Levodopa Extended-Release Capsules (IPX066) in Levodopa-Naive Patients With Parkinson Disease.

Zhongping Lily Mao, Nishit B Modi

Open access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.6field-weighted citation impact, top 17% of its field
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

4 citing papers in PubMed, 10 citations in OpenAlex.

  1. Moxibustion Protects Dopaminergic Neurons in Parkinson's Disease through Antiferroptosis.Evidence-based complementary and alternative medicine : eCAM · 2021
    Article
  2. Extended-release oral capsule of carbidopa-levodopa in Parkinson disease.Therapeutic advances in neurological disorders · 2018
    Review
  3. Pharmacokinetics of RytaryClinical pharmacokinetics · 2017
    Review
  4. 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

2 authors at 1 institution in 1 country.

Zhongping Lily MaoImpax Specialty Pharma, a division of Impax Laboratories, Inc, Hayward, CA, USA.
Nishit B ModiImpax Specialty Pharma, a division of Impax Laboratories, Inc, Hayward, CA, USA.
Institute for Magnetospheric Physics · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Parkinson disease is an age-related disorder of the central nervous system principally due to loss of dopamine-producing cells in the midbrain. Levodopa, in combination with carbidopa, is widely regarded as an effective treatment for the symptoms of Parkinson disease. A dose-response relationship is established for carbidopa-levodopa extended-release capsules (IPX066) in levodopa-naive Parkinson disease patients using a disease progression model. Unified Parkinson Disease Rating Scale (UPDRS) part II plus part III scores from 171 North American patients treated with placebo or IPX066 for approximately 30 weeks from a double-blind, parallel-group, dose-ranging study were used to develop the pharmacodynamic model. The model comprised 3 components: a linear function describing disease progression, a component describing placebo (or nonlevodopa) effects, and a component to describe the effect of levodopa. Natural disease progression in early Parkinson disease as measured by UPDRS was 11.6 units/year and faster in patients with more severe disease (Hoehn-Yahr stage 3). Maximum placebo/nonlevodopa response was 23.0% of baseline UPDRS. Maximum levodopa effect from IPX066 was 76.7% of baseline UPDRS, and the ED50 was 450 mg levodopa. Equilibration half-life for the effect compartment was 62.8 days. Increasing age increased and being female decreased equilibration half-life. The quantitative model allowed description of the entire time course of response to clinical trial intervention.

Indexed as

AgedAntiparkinson AgentsCapsulesCarbidopaCohort StudiesDelayed-Action PreparationsDose-Response Relationship, DrugDouble-Blind MethodDrug CombinationsFemaleHumansLevodopaMaleMiddle AgedParkinson DiseaseTreatment OutcomeAntiparkinson AgentsCapsulesCarbidopacarbidopa, levodopa drug combinationDelayed-Action PreparationsDrug CombinationsLevodopadisease progressionIPX066levodopaParkinson diseasepharmacodynamics

Identifiers

PMID26632091
PMCPMC5066683
OpenAlexW2272904297

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.