Trial reportThe Journal of pediatrics2014
Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy.
Trial report in The Journal of pediatrics, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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.
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.
Who cites it
16 citing papers in PubMed, 36 citations in OpenAlex.
- Pharmacogenomic Variability of Oral Baclofen Clearance and Clinical Response in Children With Cerebral Palsy.PM & R : the journal of injury, function, and rehabilitation · 2018Trial
- Assessment of Enteral Baclofen Prescribing Practices for Infants With Hypertonia.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Neurosurgery to restore function in cerebral palsy: current practice and emerging therapies.Frontiers in rehabilitation sciences · 2026Review
- Postoperative fever following hemispherotomy managed with baclofen: unnoticed treatment.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025Article
- Is baclofen the least worst option for spasticity management in children?Journal of pediatric rehabilitation medicine · 2023Article
- A critical evaluation of oral baclofen in pediatric patients with cerebral palsy.Journal of pediatric rehabilitation medicine · 2023Article
- Stability Study of Baclofen in an Oral Powder Form Compounded for Pediatric Patients in Japan.Children (Basel, Switzerland) · 2022Article
- Assessing a Mass-Based Method for the Preparation of Low-Dosed Paediatric Capsules with Baclofen and Spironolactone.Pharmacy (Basel, Switzerland) · 2021Article
- Treatment of Disorders of Tone and Other Considerations in Pediatric Movement Disorders.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020Review
- Drug deprescription-withdrawal risk, prevention, and treatment.Proceedings (Baylor University. Medical Center) · 2020Review
- Simultaneous Quantitation of S(+)- and R(-)-Baclofen and Its Metabolite in Human Plasma and Cerebrospinal Fluid using LC-APCI-MS/MS: An Application for Clinical Studies.Molecules (Basel, Switzerland) · 2020Article
- A Case Report of Baclofen Toxicity in a Pediatric Patient With Normal Kidney Function Successfully Treated With Hemodialysis.Canadian journal of kidney health and disease · 2020Article
- Examining the role of precision medicine with oral baclofen in pediatric patients with cerebral palsy.Current physical medicine and rehabilitation reports · 2019Article
- Multivariate Analysis and Machine Learning in Cerebral Palsy Research.Frontiers in neurology · 2017Review
- Baclofen Toxicity Responsive to Hemodialysis in a Pediatric Patient with Acute Kidney Injury.Journal of pediatric intensive care · 2016Article
- Baclofen Toxicity in Children With Acute Kidney Injury: Case Reports and Review of the Literature.Child neurology openArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
26 authors at 15 institutions in 1 country.
Funding
Abstract
objectiveTo characterize the population pharmacokinetics (PK) of oral baclofen and assess impact of patient-specific covariates in children with cerebral palsy (CP) in order to support its clinical use. SUBJECTS
designChildren (2-17 years of age) with CP received a dose of titrated oral baclofen from 2.5 mg 3 times a day to a maximum tolerated dose of up to 20 mg 4 times a day. PK sampling followed titration of 10-12 weeks. Serial R- and S-baclofen plasma concentrations were measured for up to 16 hours in 49 subjects. Population PK modeling was performed using NONMEM 7.1 (ICON PLC; Ellicott City, Maryland).
resultsR- and S-baclofen showed identical concentration-time profiles. Both baclofen enantiomers exhibited linear and dose/kg-proportional PK, and no sex differences were observed. Average baclofen terminal half-life was 4.5 hours. A 2-compartment PK model with linear elimination and transit absorption steps adequately described concentration-time profiles of both baclofen enantiomers. The mean population estimate of apparent clearance/F was 0.273 L/h/kg with 33.4% inter-individual variability (IIV), and the apparent volume of distribution (Vss/F) was 1.16 L/kg with 43.9% IIV. Delayed absorption was expressed by a mean transit time of 0.389 hours with 83.7% IIV. Body weight, a possible genetic factor, and age were determinants of apparent clearance in these children.
conclusionThe PK of oral baclofen exhibited dose-proportionality and were adequately described by a 2-compartment model. Our population PK findings suggest that baclofen dosage can be based on body weight (2 mg/kg per day) and the current baclofen dose escalation strategy is appropriate in the treatment of children with CP older than 2 years of age.
Indexed as
Identifiers
What OpenQuestion holds
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.