Evidence map›Paper›PMID 30013321›Full record

Trial reportDrug design, development and therapy2018

Comparison of nocturnal symptoms in advanced Parkinson's disease patients with sleep disturbances: pramipexole sustained release versus immediate release formulations.

Wei Xiang, Ya Qing Sun, Hui Chin Teoh

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Drug design, development and therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00466167 (A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release), 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
–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.

NCT00466167 phase3completednot on this map

A Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).

TypeinterventionalSponsorBoehringer IngelheimRan2007Enrolled517ConditionsParkinson DiseaseArmsPramipexol Extended Release, Pramipexol Immediate Release, Placebo
3 · Its place in the literature

Who cites it

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

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  20. Sleep Issues in Parkinson's Disease and Their Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    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

3 authors.

Wei XiangMedical Affairs, Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China, wei.xiang@boehringer-ingelheim.com.
Ya Qing SunBiostatistics and Data Sciences, Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.
Hui Chin TeohClinical Operations, Boehringer Ingelheim (China) Investment Co. Ltd, Shanghai, People's Republic of China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNocturnal symptoms are common in Parkinson's disease (PD), which greatly affect the quality of life but are often overlooked in clinical settings. Treatment strategies that provide sustained dopaminergic stimulation may have sleep benefits.

objectiveTo investigate the treatment effects of pramipexole (PPX) sustained release (SR) versus PPX immediate release (IR) on nocturnal symptoms in advanced PD patients with sleep disturbances. MATERIALS AND

methodsIn this study, the PPX clinical trial (NCT00466167) was retrospectively analyzed for PD Sleep Scale (PDSS) total and domain scores in patients with advanced idiopathic PD receiving either PPX SR or PPX IR, who experienced motor fluctuations while on stable levodopa with a baseline PDSS total score of <90, indicating sleep disturbances. Analysis of covariance test was used to compare the adjusted mean changes at week 18 from baseline between treatment groups, after adjusting for pooled country and baseline scores.

resultsA total of 119 patients with PD reported sleep disturbances at baseline (PDSS <90; SR, n=59; IR, n=60). At week 18, patients receiving PPX SR reported numerically greater improvement of sleep disturbance than those receiving PPX IR, although the difference of 6.8 points was not statistically significant (adjusted mean changes in PDSS total score, SR=28.5 versus IR=21.7 points,

conclusionBoth the PPX formulations showed improvements in nocturnal symptoms in advanced PD patients with sleep disturbances and were generally well tolerated. Given the known pharmacokinetic profile of an SR formulation and numerical advantage in PDSS mean change over IR formulation, these preliminary evidences support future prospectively designed studies to investigate the effects of PPX SR for improved sleep.

Indexed as

Antiparkinson AgentsDouble-Blind MethodDrug CompoundingFemaleHumansMaleMaximum Tolerated DoseMiddle AgedParkinson DiseasePramipexoleSleepSleep Wake DisordersSoftwareAntiparkinson AgentsPramipexoledopamine agonistefficacynonmotor symptomsParkinson’s diseaseParkinson’s Disease Sleep Scalepramipexole extended release

Identifiers

PMID30013321
PMCPMC6037405

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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.