Evidence map›Paper›PMID 26444090›Full record

Trial reportJournal of Parkinson's disease2015

Conversion to IPX066 from Standard Levodopa Formulations in Advanced Parkinson's Disease: Experience in Clinical Trials.

Paul A Nausieda, Ann Hsu, Lawrence Elmer, Ramon A Gil, Joerg Spiegel, Carlos Singer, Sarita Khanna, Robert Rubens, Sherron Kell, Nishit B Modi and 1 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of Parkinson's disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.8field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 26 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Extended-release oral capsule of carbidopa-levodopa in Parkinson disease.Therapeutic advances in neurological disorders · 2018
    Review
  5. Article
  6. Review
  7. Review
  8. Review
  9. 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

11 authors at 3 institutions in 2 countries.

Paul A NausiedaWisconsin Institute for Neurologic and Sleep Disorders, Milwaukee, WI, USA.
Ann HsuImpax Laboratories, Inc., Hayward, CA, USA.
Lawrence ElmerUniversity of Toledo College of Medicine, Toledo, OH, USA.
Ramon A GilCharlotte Neurological Services, Port Charlotte, FL, USA.
Joerg SpiegelSaarland University, Homburg/Saar, Germany.
Carlos SingerUniversity of Miami, Miami, FL, USA.
Sarita KhannaImpax Laboratories, Inc., Hayward, CA, USA.
Robert RubensImpax Laboratories, Inc., Hayward, CA, USA.
Sherron KellImpax Laboratories, Inc., Hayward, CA, USA.
Nishit B ModiImpax Laboratories, Inc., Hayward, CA, USA.
Suneel GuptaImpax Laboratories, Inc., Hayward, CA, USA.
Saarland University · DEUniversity of Miami · USUniversity of Toledo · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to the short half-life of levodopa, immediate-release carbidopa-levodopa (IR CD-LD) produces fluctuating LD concentrations, contributing to a risk of eventual motor complications. IPX066 was designed to rapidly attain therapeutic LD concentrations and maintain them to allow a dosing interval of ∼6 hours.

objectiveTo extensively analyze the dosing data collected in IPX066 studies during open-label conversions from IR CD-LD alone or with entacapone (CLE) and identify patterns relevant for managing conversion in the clinical setting.

methodsPatients had ≥2.5 hours/day of "off" time despite a stable IR or CLE regimen. Suggested initial dosing conversion tables based on prior LD daily dosage were provided.

resultsOf 450 patients previously treated with IR CD-LD and 110 with CLE, 87.3% and 82.7% completed conversion to IPX066, respectively. At the end of conversion, average IPX066 LD daily dosages were higher than pre-conversion dosages, with a mean conversion ratio of 2.1±0.6 for IR CD-LD and 2.8±0.8 for CLE; >90% of patients took IPX066 3 or 4 times/day, compared with a median of 5 times/day at baseline in both studies. After conversion, daily "off" time significantly decreased, with no significant increase in troublesome dyskinesia. The most common adverse event reported during conversion was nausea, with an incidence of 5.3% for conversion from IR and 7.3% from CLE.

conclusionsAmong PD patients with substantial "off" time, a majority were safely converted to IPX066. The sustained LD profile from the IPX066 formulation allowed an increase in LD dose accompanied by improved motor functions, without increased troublesome dyskinesia.

Indexed as

Outcome Assessment, Health CareAgedAntiparkinson AgentsCarbidopaCatecholsCross-Over StudiesDouble-Blind MethodDrug Administration ScheduleDrug CombinationsFemaleHumansLevodopaMaleMiddle AgedNitrilesParkinson DiseaseAntiparkinson AgentsCarbidopacarbidopa, levodopa drug combinationCatecholsDrug CombinationsentacaponeLevodopaNitrilesdyskinesiaextended-releaseLevodopaoff-timeon-timeParkinson’s disease

Identifiers

PMID26444090
PMCPMC4927929
OpenAlexW1854692748

What OpenQuestion holds

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LicenceCC BY-NC
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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.