CMT - Charcot-Marie-Tooth DiseaseCMT-autonomNCT07570446
AUTONOMOUS DISORDERS IN CMT
An observational study of CMT - Charcot-Marie-Tooth Disease and CMT1A, run by University Medical Center Goettingen at 1 site in Germany.
Trial summary
Hereditary neuropathies are a phenotypically and genetically heterogeneous group of disorders. One of the most common forms is Charcot-Marie-Tooth neuropathy (CMT), which can be further divided into demyelinating (CMT1) and axonal (CMT2) neuropathies, as well as various pathogenic genetic variants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- CMT - Charcot-Marie-Tooth Disease, CMT1A, CMT (Charcot Marie Tooth Disease)
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 30 Jul 2024to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants from the Biomarkers and Validation of Selected Outcome Measures (CMTNSmod) study (ClinicalTrials.gov ID NCT03386266)
Who may be able to join
- Clinical CMT Diagnosis / Anamnestically Healthy Control Group
- Genetic confirmation of CMT in adult patients
- Ability to achieve the outcome measure at baseline
- Age between 18 and 65 years
- Capacity of all study participants to consent and signed informed consent, - including patient or participant information and consent form
Who cannot join
- Pregnancy or breastfeeding period
- Other relevant neurological or psychiatric disorders, acute or in the past history
- Presence of a serious previous internal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Centre
Göttingen, Lower Saxony, 37075
Sandrin Plewe, +49 551 3964162, sandrin.plewe@med.uni-goettingen.de
About this study
Hereditary neuropathies are a phenotypically and genetically heterogeneous group of disorders. One of the most common forms is Charcot-Marie-Tooth neuropathy (CMT), which can be further divided into demyelinating (CMT1) and axonal (CMT2) neuropathies, as well as various pathogenic genetic variants. In addition to the clinically predominant motor and sensory deficits, symptoms of the autonomic nervous system have also been described in patients with CMT, often leading to significant limitations in daily functioning and quality of life. However, little is known about the prevalence and extent of autonomic dysfunction in CMT patients.
In this study, patients with CMT will be assessed for the presence, severity, and characteristics of autonomic dysfunction using questionnaires and non-invasive diagnostic methods. Furthermore, diagnosis, genotype, and individual disease data-such as disease duration, severity of neurological impairment, and comorbidities-will be collected from patient records.
The aim of this study is to evaluate and characterize autonomic dysfunction in patients with CMT. It seeks to determine how frequently autonomic dysfunction occurs in CMT, which areas of the autonomic nervous system are most commonly affected, whether risk factors exist, and what differences can be observed between the various CMT subtypes. The findings of this study are expected to provide new insights into the role of autonomic dysfunction in CMT, ultimately contributing to improved care and treatment for affected patients.
- Medical subject headings
- Charcot-Marie-Tooth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CMT patients | Not described | |
| Controls | Healthy age-matched controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPASS 31
validated questionaire
Measured: baseline
electrophysiological measurement
Validated electrophysiological examinations including the sympathetic skin reflex, the Schellong test, and heart rate variability measurement
Measured: baseline
Secondary outcomes (3)
muscle strength
Measured: baseline
neurography
Examinations measuring the electrical activity and conductivity of nerves, which are used to diagnose nerve damage or diseases.
Measured: baseline
nerve sonography
Measured: at visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Jul 2024
- Primary completion5 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMT - Charcot-Marie-Tooth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael W Sereda, MD, Professor of Neurology, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570446
- Sponsor's protocol ID
- 17/05/2024_C2
- Acronym
- CMT-autonom
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AUTONOMOUS DISORDERS IN CMT
- ClinicalTrials.gov ID
- NCT07570446
- Acronym / sponsor ID
- CMT-autonom / 17/05/2024_C2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 5 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hereditary neuropathies are a phenotypically and genetically heterogeneous group of disorders. One of the most common forms is Charcot-Marie-Tooth neuropathy (CMT), which can be further divided into demyelinating (CMT1) and axonal (CMT2) neuropathies, as well as various pathogenic genetic variants. In addition to the clinically predominant motor and sensory deficits, symptoms of the autonomic nervous system have also been described in patients with CMT, often leading to significant limitations in daily functioning and quality of life. However, little is known about the prevalence and extent of autonomic dysfunction in CMT patients.
In this study, patients with CMT will be assessed for the presence, severity, and characteristics of autonomic dysfunction using questionnaires and non-invasive diagnostic methods. Furthermore, diagnosis, genotype, and individual disease data-such as disease duration, severity of neurological impairment, and comorbidities-will be collected from patient records.
The aim of this study is to evaluate and characterize autonomic dysfunction in patients with CMT. It seeks to determine how frequently autonomic dysfunction occurs in CMT, which areas of the autonomic nervous system are most commonly affected, whether risk factors exist, and what differences can be observed between the various CMT subtypes. The findings of this study are expected to provide new insights into the role of autonomic dysfunction in CMT, ultimately contributing to improved care and treatment for affected patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMT patients | – | – |
| Controls | – | –Healthy age-matched controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants from the Biomarkers and Validation of Selected Outcome Measures (CMTNSmod) study (ClinicalTrials.gov ID NCT03386266)
Key inclusion criteria (5 listed)
- Clinical CMT Diagnosis / Anamnestically Healthy Control Group
- Genetic confirmation of CMT in adult patients
- Ability to achieve the outcome measure at baseline
- Age between 18 and 65 years
- Capacity of all study participants to consent and signed informed consent, - including patient or participant information and consent form
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding period
- Other relevant neurological or psychiatric disorders, acute or in the past history
- Presence of a serious previous internal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
COMPASS 31
Time frame: baseline
validated questionaire
electrophysiological measurement
Time frame: baseline
Validated electrophysiological examinations including the sympathetic skin reflex, the Schellong test, and heart rate variability measurement
3 secondary outcomes
muscle strength
Time frame: baseline
neurography
Time frame: baseline
nerve sonography
Time frame: at visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMT - Charcot-Marie-Tooth Disease and CMT1A, run by University Medical Center Goettingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael W Sereda, Prof. MD (+49 551 3964162, sereda@mpinat.mpg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPASS 31 (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.