Evidence mapPaperPMID 35477351Full record

Trial reportBMC neurology2022

A randomised placebo-controlled, double-blind phase II study to explore the safety, efficacy, and pharmacokinetics of sonlicromanol in children with genetically confirmed mitochondrial disease and motor symptoms ("KHENERGYC").

Jan Smeitink, Rob van Maanen, Lonneke de Boer, Gerrit Ruiterkamp, Herma Renkema

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

Trial report in BMC neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04846036 (A Randomized Placebo Controlled, Double-blind Phase II Study to Explore the Safety, Efficacy and Pharmacokinetics of Sonlicromanol in Children With Genetically Confirmed Mitochondrial Disease), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 32% 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.

NCT04846036 phase2suspendednot on this map

A Randomized Placebo Controlled, Double-blind Phase II Study to Explore the Safety, Efficacy and Pharmacokinetics of Sonlicromanol in Children With Genetically Confirmed Mitochondrial Disease

TypeinterventionalSponsorKhondrion BVRan2021 to 2025Enrolled24ConditionsMitochondrial Diseases, Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation, MELAS, Subacute Necrotizing EncephalomyelopathyArmsSonlicromanol, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Observational
  4. Review
  5. Observational
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.

Jan SmeitinkKhondrion BV, Transistorweg 5C, M Building, 6534, AT, Nijmegen, The Netherlands. info@khondrion.com.
Rob van MaanenKhondrion BV, Transistorweg 5C, M Building, 6534, AT, Nijmegen, The Netherlands.
Lonneke de BoerRadboud Center for Mitochondrial Medicine, Department of Pediatrics, Radboud University Medical Center Nijmegen, Geert Grooteplein Zuid 10, 6500 HB, Nijmegen, The Netherlands.
Gerrit RuiterkampKhondrion BV, Transistorweg 5C, M Building, 6534, AT, Nijmegen, The Netherlands.
Herma RenkemaKhondrion BV, Transistorweg 5C, M Building, 6534, AT, Nijmegen, The Netherlands.
Khondrion (Netherlands) · NLRadboud University Medical Center · NL

Funding

European Regional Development Fund NAFoundation Energy4All NAFoundation Join4Energy NAFoundation Road4Energy NATim Foundation Ride4Kids NA
6 · The paper itself

Abstract

background

methodsThe KHENERGYC trial will be a phase II, randomised, double-blinded, placebo-controlled (DBPC), parallel-group study in the paediatric population (birth up to and including 17 years). The study will be recruiting 24 patients suffering from motor symptoms due to genetically confirmed PMD. The trial will be divided into two phases. The first phase of the study will be an adaptive pharmacokinetic (PK) study with four days of treatment, while the second phase will include randomisation of the participants and evaluating the efficacy and safety of sonlicromanol over 6 months. DISCUSSION: Effective novel therapies for treating PMDs in children are an unmet need. This study will assess the pharmacokinetics, efficacy, and safety of sonlicromanol in children with genetically confirmed PMDs, suffering from motor symptoms.

trial registrationclinicaltrials.gov: NCT04846036 , registered April 15, 2021. European Union Clinical Trial Register (EUDRACT number: 2020-003124-16 ), registered October 20, 2020. CCMO registration: NL75221.091.20, registered on October 7, 2020.

Indexed as

AntioxidantsMitochondrial DiseasesChildDouble-Blind MethodHumansTreatment OutcomeAntioxidantsChildrenClinical study protocolGMFMKH176Mitochondrial diseasesOXPHOSRedox metabolismSonlicromanol

Identifiers

PMID35477351
PMCPMC9044835
OpenAlexW4225090651

What Socratic holds

Textmetadata
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 Socratic graph.