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RecruitingNCT07690111TRPM3CareUpdated Jul 8, 2026

International Registry for TRPM3-associated Disorders

An observational study in TRPM3, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Charite University, Berlin, Germany · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Sex
All
01

Study summary

The goal of the TRPM3Care-registry is to record the disease progression of patients with TRPM3-associated disorders. This allows us to compare the disease progression and the success of different therapies, as well as to examine their impact on quality of life.

Read the detailed description

Transient Receptor Potential Melastatin 3 (TRPM3) is a calcium-permeable, non-selective cation channel that is widely expressed in the central and peripheral nervous system, sensory neurons, pancreatic β-cells, vascular smooth muscle, and several other tissues. TRPM3 plays an essential role in intracellular calcium signaling and contributes to neuronal excitability, thermosensation, nociception, insulin secretion, and cellular homeostasis.

Over the past decade, pathogenic germline variants in TRPM3 have been identified as the cause of a rare neurodevelopmental disorder characterized by developmental delay, intellectual disability, epilepsy, hypotonia, movement disorders, and variable neurobehavioral manifestations. The clinical spectrum is expanding as additional patients are identified through next-generation sequencing, revealing considerable phenotypic variability and an incomplete understanding of genotype-phenotype relationships.

Due to the rarity of TRPM3-associated disorders, clinical knowledge is currently limited to relatively small case series and individual case reports. Consequently, there is an urgent need for systematic collection of standardized clinical, genetic, imaging, electrophysiological, and longitudinal outcome data to better characterize the natural history of these disorders and to facilitate future therapeutic research.

Purpose of the Registry

The TRPM3Care Registry is an international, multicenter observational registry established to collect comprehensive clinical and molecular data from individuals carrying pathogenic or likely pathogenic variants in the TRPM3 gene, as well as individuals with variants of uncertain significance when supported by compatible clinical findings.

The registry aims to provide a centralized resource for clinicians and researchers to improve understanding of disease mechanisms, define the phenotypic spectrum, establish genotype-phenotype correlations, identify prognostic markers, evaluate disease progression, and support the development of evidence-based clinical management recommendations.

02

Conditions studied

  • TRPM3

Keywords

  • TRPM3
03

In context

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients with TRPM3 variants can be included

Inclusion criteria

  • Variant in the TRPM3 gene

Exclusion criteria

Exclusion Criteria:

  • no consent from patient/familiy
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Developmental Delay

    Development in patients

    Time frame: 10 years

Secondary outcomes

  1. Epilepsy

    epilepsy type and seizure frequency

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • Charité- Universitätsmedizin Berlin- Neuropediatrics
    Berlin, State of Berlin 13353, Germany
    Recruiting
08

References and documents

Publications

  • Jolitz L, Helbig I, Fitzgerald MP, McKeown Ruggiero S, Cohen S, Angelini C, Vallespin E, Michaud V, Gerasimenko A, Cogne B, Isidor B, Keren B, Dyment D, Heron D, Karstensen HG, Cuppen I, Christodoulou J, Wilson M, Lake NJ, Biskup S, Syrbe S, Mori T, Becker LL, Kaindl AM. Phenotype Spectrum of TRPM3-Associated Disorders. Ann Neurol. 2025 Mar;97(3):561-570. doi: 10.1002/ana.27141. Epub 2025 Jan 3. PubMed 39749750 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07690111
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Lena-Luise Becker (Principal Investigator, Charite University, Berlin, Germany) — Principal investigator
First posted
Jul 8, 2026
Start date
Jan 1, 2026
Primary completion
Jan 1, 2036 (estimated)
Completion
Dec 31, 2036 (estimated)
Last update
Jul 8, 2026

Study contacts

Lena-Luise Becker, Dr. med.
Contact
lena-luise.becker@charite.de
0049 03 450 566 122
Angela M. Kaindl, Prof. Dr.
Contact
angela.kaindl@charite.de
0049 03 450 566 112
Lena-Luise Becker, Dr. med.
principal investigator · Charité- Universitätsmeidzin Berlin- Neuropediatrics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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