Global Registry and Natural History Study for Mitochondrial Disorders

NCT ID: NCT05554835

Last Updated: 2025-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-01

Study Completion Date

2040-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The global mitochondrial registry and natural history study is part of the EU-financed GENOMIT project, co-ordinated by Dr. Holger Prokisch, Technische Universität München (TUM).It aims at advancing the understanding of the natural history of mitochondrial disease to inform the design and facilitate the conduction of clinical trials. It also serves as a catalyst for translating basic research results into clinical practice.

The global mitochondrial registry and natural history study provides for all contingencies of national ethics and data protection rules including data access management.

Currently participating networks are:

* German network for mitochondrial diseases - mitoNET, Germany/Austria
* Italian Registry of Mitochondrial Patients - Mitocon, Italy

The inclusion of other networks and countries is possible and explicitly welcome. A major advantage of the global registry is that countries can join in, saving a lot of time, effort and funding.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitochondrial Diseases Kearns-Sayre Syndrome MIDD SANDO SCAE NARP Syndrome MELAS Syndrome MERRF Syndrome Coenzyme Q10 Deficiency LHON MNGIE MIRAS Barth Syndrome MDS Mitochondrial Myopathies Leigh Syndrome Pearson Syndrome CPEO

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mitochondrial patients

Patients with a suspected or confirmed mitochondrial disease.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* suspected or confirmed mitochondrial disease
* willingness to participate

Exclusion Criteria

* unwillingness to participate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

European Commission

OTHER

Sponsor Role collaborator

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Pisa

OTHER

Sponsor Role collaborator

LMU Klinikum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Thomas Klopstock

Prof. Dr. Thomas Klopstock

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Klopstock, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

LMU Klinikum, Munich

Michelangelo Mancuso, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Università di Pisa

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University Innsbruck, Department of Pediatrics

Innsbruck, , Austria

Site Status RECRUITING

Salzburger Landeskliniken, SALK, Paracelsus Medizinische Privatuniversität

Salzburg, , Austria

Site Status RECRUITING

Department of neurology, Klinikum rechts der Isar, Technical University Munich

Munich, Bavaria, Germany

Site Status RECRUITING

Charité Virchow Klinikum, Klinik für Pädiatrie m. S. Neurologie

Berlin, , Germany

Site Status RECRUITING

Universität Bonn, Klinik und Poliklinik für Neurologie

Bonn, , Germany

Site Status RECRUITING

Universitätsklinikum Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin

Cologne, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf, Klinik für allgemeine Pädiatrie, Neonatologie und Kinderkardiologie

Düsseldorf, , Germany

Site Status RECRUITING

Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Schwerpunkt Neurologie, Neurometabolik und Prävention

Frankfurt am Main, , Germany

Site Status RECRUITING

University Medical Center Freiburg, Center for children and youth medicine

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Martin-Luther-Universität Halle-Wittenberg, Neurologische Klinik und Poliklinik

Halle, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg Eppendorf Institut für Humangenetik

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg Eppendorf, Klinik für Kinder-und Jugendmedizin

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg Eppendorf, Klinik für Neurologie

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin, Sektion für Neuropädiatrie und Stoffwechselmedizin

Heidelberg, , Germany

Site Status RECRUITING

LMU Klinikum, Friedrich-Baur-Institut an der Neurologischen Klinik und Poliklinik

München, , Germany

Site Status RECRUITING

Klinikum am Steinenberg, Kreiskliniken Reutlingen, Klinik für Kinder-und Jugendmedizin, Perinatal- u. Stoffwechselzentrum

Reutlingen, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen, Neurologische Klinik und Hertie Institut für Klinische Hirnforschung

Tübingen, , Germany

Site Status RECRUITING

Department of Clinical and Experimental Medicine, Neurological Institute, University of Pisa & AOUP

Pisa, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Boriana Büchner, Dr.

Role: CONTACT

+49 89 4400 ext. 57067

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Daniela Karall, Prof. Dr.

Role: primary

+43 512 504 ext. 23600

Saskia Wortmann, PD Dr. med.

Role: primary

+43 5 7255 ext. 26222

Elisa Floride, Dr.

Role: backup

+43 5 7255 ext. 26222

Marcus Deschauer, Prof. Dr.

Role: primary

+49 89 4140 ext. 4617

Luisa Semmler

Role: backup

Markus Schülke-Gerstenfeld, Prof.Dr.med.

Role: primary

+49 30 4505 66112

Cornelia Kornblum, Prof. Dr.

Role: primary

+49 228 287 15712

Jürgen-Christoph von Kleist-Retzow, PD Dr.

Role: primary

+49 221 478 5900

Felix Distelmaier, Prof. Dr.

Role: primary

+49 211 811 7696

Matthias Kieslich, Prof.Dr.med.

Role: primary

+49 69 6301 5560

Martin Lindner, PD Dr. med.

Role: backup

Matthias Eckenweiler, Dr.

Role: primary

+49 761 270 ext. 43750

Simone Bürklin

Role: backup

+49 761 270 ext. 44970

Alexander Mensch, Dr. med.

Role: primary

49 345 557 2856

Annamarie Thäle, Dr. med.

Role: backup

Maja Hempel, PD Dr. med.

Role: primary

+49 40 7410 50772

René Santer, Prof.Dr.med.

Role: primary

+49 40 7410 52710

Konstantinos Tsiakas, Dr. med.

Role: backup

Simone Zittel-Dirks, PD Dr. med.

Role: primary

Georg F. Hoffmann, Prof. Dr.

Role: primary

+49 6221 56 4837

Nikolas Boy, PD Dr. med.

Role: backup

+49 6221 56 4002

Thomas Klopstock, Prof. Dr.

Role: primary

+49 89 4400 57400

Boriana Büchner, Dr. med.

Role: backup

+49 89 4400 57067

Peter Freisinger, Prof. Dr.

Role: primary

+49 7121 200 4051

Vanessa Kock, Dr. med.

Role: backup

+49 7121 200 4060

Ludger Schöls, Prof. Dr.

Role: primary

+49 7071 29 82057

Michaelangelo Mancuso, Prof. Dr.

Role: primary

+39 (0)50 992443

References

Explore related publications, articles, or registry entries linked to this study.

Stenton SL, Sheremet NL, Catarino CB, Andreeva NA, Assouline Z, Barboni P, Barel O, Berutti R, Bychkov I, Caporali L, Capristo M, Carbonelli M, Cascavilla ML, Charbel Issa P, Freisinger P, Gerber S, Ghezzi D, Graf E, Heidler J, Hempel M, Heon E, Itkis YS, Javasky E, Kaplan J, Kopajtich R, Kornblum C, Kovacs-Nagy R, Krylova TD, Kunz WS, La Morgia C, Lamperti C, Ludwig C, Malacarne PF, Maresca A, Mayr JA, Meisterknecht J, Nevinitsyna TA, Palombo F, Pode-Shakked B, Shmelkova MS, Strom TM, Tagliavini F, Tzadok M, van der Ven AT, Vignal-Clermont C, Wagner M, Zakharova EY, Zhorzholadze NV, Rozet JM, Carelli V, Tsygankova PG, Klopstock T, Wittig I, Prokisch H. Impaired complex I repair causes recessive Leber's hereditary optic neuropathy. J Clin Invest. 2021 Mar 15;131(6):e138267. doi: 10.1172/JCI138267.

Reference Type BACKGROUND
PMID: 33465056 (View on PubMed)

Stendel C, Neuhofer C, Floride E, Yuqing S, Ganetzky RD, Park J, Freisinger P, Kornblum C, Kleinle S, Schols L, Distelmaier F, Stettner GM, Buchner B, Falk MJ, Mayr JA, Synofzik M, Abicht A, Haack TB, Prokisch H, Wortmann SB, Murayama K, Fang F, Klopstock T; ATP6 Study Group. Delineating MT-ATP6-associated disease: From isolated neuropathy to early onset neurodegeneration. Neurol Genet. 2020 Jan 13;6(1):e393. doi: 10.1212/NXG.0000000000000393. eCollection 2020 Feb.

Reference Type BACKGROUND
PMID: 32042921 (View on PubMed)

Ng YS, Bindoff LA, Gorman GS, Klopstock T, Kornblum C, Mancuso M, McFarland R, Sue CM, Suomalainen A, Taylor RW, Thorburn DR, Turnbull DM. Mitochondrial disease in adults: recent advances and future promise. Lancet Neurol. 2021 Jul;20(7):573-584. doi: 10.1016/S1474-4422(21)00098-3.

Reference Type BACKGROUND
PMID: 34146515 (View on PubMed)

Ng YS, Bindoff LA, Gorman GS, Horvath R, Klopstock T, Mancuso M, Martikainen MH, Mcfarland R, Nesbitt V, Pitceathly RDS, Schaefer AM, Turnbull DM. Consensus-based statements for the management of mitochondrial stroke-like episodes. Wellcome Open Res. 2019 Dec 13;4:201. doi: 10.12688/wellcomeopenres.15599.1. eCollection 2019.

Reference Type BACKGROUND
PMID: 32090171 (View on PubMed)

Mancuso M, McFarland R, Klopstock T, Hirano M; consortium on Trial Readiness in Mitochondrial Myopathies. International Workshop:: Outcome measures and clinical trial readiness in primary mitochondrial myopathies in children and adults. Consensus recommendations. 16-18 November 2016, Rome, Italy. Neuromuscul Disord. 2017 Dec;27(12):1126-1137. doi: 10.1016/j.nmd.2017.08.006. Epub 2017 Sep 8. No abstract available.

Reference Type BACKGROUND
PMID: 29074296 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

mitoGLOBAL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Genetic Studies of Lysosomal Storage Disorders
NCT00001215 ENROLLING_BY_INVITATION
Rare and Undiagnosed Disease Research Biorepository
NCT04703179 ENROLLING_BY_INVITATION
Neurogenetics Patient Registry
NCT02995538 RECRUITING