Evidence map›Paper›PMID 30425824›Full record

ArticleParkinson's disease2018

Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations.

John C Morgan, Rohit Dhall, Robert Rubens, Sarita Khanna, Suneel Gupta

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Parkinson's disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 28% 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.

NCT00974974 phase3completednot on this map

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease

TypeinterventionalSponsorImpax Laboratories, LLCRan2009 to 2011Enrolled471ConditionsParkinson's DiseaseArmsIPX066, IR CD-LD
NCT01130493 phase3completednot on this map

A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's Disease

TypeinterventionalSponsorImpax Laboratories, LLCRan2010 to 2012Enrolled110ConditionsParkinson's DiseaseArmsIPX066, CLE
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Medical Management and Prevention of Motor Complications in Parkinson's Disease.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
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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

5 authors at 2 institutions in 1 country.

John C MorganMovement Disorders Program, Parkinson's Foundation Center of Excellence, Department of Neurology, Medical College of Georgia, Augusta University, 1429 Harper Street, HF-1154, Augusta, GA 30912, USA.ORCID 0000-0001-5279-5026
Rohit DhallUniversity of Arkansas for Medical Science, 4301 W. Markham Street, Little Rock, AR 72205, USA.ORCID 0000-0001-9436-1920
Robert RubensImpax Laboratories, LLC, 31047 Genstar Road, Hayward, CA 94544, USA.
Sarita KhannaImpax Laboratories, LLC, 31047 Genstar Road, Hayward, CA 94544, USA.
Suneel GuptaImpax Laboratories, LLC, 31047 Genstar Road, Hayward, CA 94544, USA.ORCID 0000-0001-7813-9940
Augusta University · USUniversity of Arkansas for Medical Sciences · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIPX066 is an extended-release (ER) oral formulation of carbidopa-levodopa (CD-LD). Following an initial peak at about one hour, plasma LD concentrations are maintained for about 4-5 hours.

objectiveTo present dosing factors that may affect the successful conversion to ER CD-LD from other LD formulations.

methodsTwo-phase 3 studies of ER CD-LD vs. immediate-release (IR) CD-LD (ADVANCE-PD) and vs. CD-LD + entacapone (CLE; ASCEND-PD) in subjects with advanced PD included a 6-week, open-label conversion to ER CD-LD prior to treatment randomization. The "converted" daily LD dose ratio and dose frequency for ER CD-LD were compared to the prior LD treatment regimens at study entry.

resultsThe average daily LD dose ratio at the end of dose conversion to ER CD-LD was approximately 2.1 for IR CD-LD and 2.8 for CLE. The final dose ratios tended to be slightly higher for participants taking lower LD doses at study entry but independent of dose frequency. ER CD-LD dose frequency increased with increasing LD dose and dose frequency at study entry. Participants on higher baseline LD doses ≥800 mg and dose frequencies ≥6 tended to have higher rates of discontinuation during conversion to ER CD-LD.

conclusionsConverting participants from other LD formulations to ER CD-LD is based on their current LD regimen. For the most common daily doses (≤1250 mg) and dose frequencies (<7) of LD, final mean dose ratios were within tight ranges of 2.1 to 2.4 for IR CD-LD (ADVANCE-PD) and 2.4 to 2.8 for CLE (ASCEND-PD) and were generally independent of the LD dosing frequency at study entry. These trials are registered with NCT00974974, NCT01130493.

Identifiers

PMID30425824
PMCPMC6217748
OpenAlexW2896399621

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.