Evidence map›Paper›PMID 30824559›Full record

Trial reportNeurology2019

Increased dose of carbidopa with levodopa and entacapone improves "off" time in a randomized trial.

Claudia Trenkwalder, Mikko Kuoppamäki, Mikko Vahteristo, Thomas Müller, Juha Ellmén

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01766258 (Efficacy and Safety of ODM-101 Compared to a Standard Combination), which is not on this map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% 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.

NCT01766258 phase2completednot on this map

Efficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor Fluctuations

TypeinterventionalSponsorOrion Corporation, Orion PharmaRan2011 to 2012Enrolled117ConditionsParkinson's DiseaseArmsODM-101 65mg Carbidopa, ODM-101 105mg Carbidopa, Stalevo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.

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  10. Gait-Guard: Turn-aware Freezing of Gait Detection for Non-intrusive Intervention Systems....IEEE...International Conference on Connected Health: Applications, Systems and Engineering Technologies. IEEE International Conference on Connected Health: Applications, Systems and Engineering Technologies · 2024
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  13. FoG-Finder: Real-time Freezing of Gait Detection and Treatment....IEEE...International Conference on Connected Health: Applications, Systems and Engineering Technologies. IEEE International Conference on Connected Health: Applications, Systems and Engineering Technologies · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Claudia TrenkwalderFrom the Clinic of Neurosurgery (C.T.), University Medical Center of Goettingen, Germany; Orion Pharma (M.K., M.V., J.E.), Espoo, Finland; and Klink für Neurologie (T.M.), Alexianer St. Joseph Berlin-Weissensee GmbH, Germany. claudia.trenkwalder@med.uni-goettingen.de.
Mikko KuoppamäkiFrom the Clinic of Neurosurgery (C.T.), University Medical Center of Goettingen, Germany; Orion Pharma (M.K., M.V., J.E.), Espoo, Finland; and Klink für Neurologie (T.M.), Alexianer St. Joseph Berlin-Weissensee GmbH, Germany.
Mikko VahteristoFrom the Clinic of Neurosurgery (C.T.), University Medical Center of Goettingen, Germany; Orion Pharma (M.K., M.V., J.E.), Espoo, Finland; and Klink für Neurologie (T.M.), Alexianer St. Joseph Berlin-Weissensee GmbH, Germany.
Thomas MüllerFrom the Clinic of Neurosurgery (C.T.), University Medical Center of Goettingen, Germany; Orion Pharma (M.K., M.V., J.E.), Espoo, Finland; and Klink für Neurologie (T.M.), Alexianer St. Joseph Berlin-Weissensee GmbH, Germany.
Juha EllménFrom the Clinic of Neurosurgery (C.T.), University Medical Center of Goettingen, Germany; Orion Pharma (M.K., M.V., J.E.), Espoo, Finland; and Klink für Neurologie (T.M.), Alexianer St. Joseph Berlin-Weissensee GmbH, Germany.
Orion Corporation (Finland) · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate whether increased fixed carbidopa doses of 65 or 105 mg (ODM-101/65 and ODM-101/105) in combination with 75, 100, 125, or 150 mg of levodopa and 200 mg of entacapone might improve "off" time in fluctuating Parkinson disease (PD) compared to the standard combination of 4:1 levodopa/carbidopa with the usual 200 mg of entacapone (LCE) during a 4-week treatment period.

methodsThis was a randomized, double-blind, double-dummy, active-controlled, crossover, multicenter, phase II, proof-of-concept study in patients with fluctuating PD.

resultsOne hundred seventeen patients were randomized into the study (mean age 67.0 years; daily "off" time 5.3 hours; mean daily levodopa dose 610 mg). Carryover-adjusted mean changes from baseline "off" times were during ODM-101/65, -1.53 hours (

conclusionIncreasing the dose of carbidopa in combination with levodopa and entacapone should be considered in the treatment of fluctuating PD to improve daily "off" times. Genotyping patients with PD according to COMT activity may improve individual treatment strategies. CLINICALTRIALSGOV IDENTIFIER: NCT01766258. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that an increased dose of carbidopa improves motor fluctuations when administered with levodopa and entacapone.

Indexed as

AgedAntiparkinson AgentsCarbidopaCatecholsCross-Over StudiesDouble-Blind MethodDrug Therapy, CombinationFemaleHumansLevodopaMaleMiddle AgedNitrilesParkinson DiseaseProof of Concept StudyTreatment OutcomeAntiparkinson AgentsCarbidopaCatecholsentacaponeLevodopaNitriles

Identifiers

PMID30824559
PMCPMC6453771
OpenAlexW2919540555

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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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.