NCT05102916

Brief Summary

The Swiss Patient Registry for DMD/BMD and SMA was launched in 2008 in order to give Swiss patients access to new therapies. It was founded with the financial support of several patient organizations and research foundations. Since 2008, children, adolescents and adults with DMD, BMD and SMA are registered with the help of all major muscle centers in Switzerland. After nearly ten years of activity, the Swiss Patient Registry for DMD/BMD and SMA implemented several adaptations in 2018 to meet current and future expectations of patient's organizations, health authorities and research organizations.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
544mo left

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jun 2018Jan 2071

Study Start

First participant enrolled

June 20, 2018

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
49.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2071

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2071

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

52.6 years

First QC Date

October 20, 2021

Last Update Submit

January 13, 2026

Conditions

Keywords

DMDBMDIMDSMALAMA2COL-6CMDNMD

Outcome Measures

Primary Outcomes (29)

  • Personal data

    Registering and updating patients personal data

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Initial symptoms

    Initial symptoms

    At diagnosis

  • Age at initial symptoms and diagnosis

    Age at initial symptoms and diagnosis

    At diagnosis

  • Family history

    Other affected family members

    At diagnosis

  • Investigations

    Type of investigations for diagnosis

    At diagnosis

  • Diagnosis

    Mutation

    At diagnosis

  • Change of living status

    Date of death

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change of living status II

    Cause of death

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in height

    Registering height

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in weight

    Registering weight

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in head circumference

    Registering head circumference

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in motor development and motor functions

    Registering motor development and function (motor function scales)

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in musculoskeletal system

    Assessing change in musculoskeletal system over time

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • History of surgeries

    Registering surgeries

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in cardiac function

    Registering cardiac function

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in pulmonary function

    Registering pulmonary function

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in nutritional habits

    Registering feeding habits

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in cognition

    Assessing mental ability using tests, including language

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in education

    Registering type of education

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in therapies

    Registering therapies

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in orthopaedic situation

    Assessing use of orthopaedic resources

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in treatments

    Registering treatments

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in side effects

    Registering side effects of treatments

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in comorbidities

    Registering comorbidities

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • History of hospitalizations

    Registering hospitalizations

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in disease specific markers

    Registering change in disease specific markers

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Change in epilepsy

    Registering epilepsy

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • History of participation in clinical trials and research studies

    Registering participation in current/past clinical trials and research studies

    Baseline medical information, follow-up data collection at regular intervals (at diagnosis, then at least annually, up to 80 years)

  • Questionnaire data

    Questionnaires focusing on specific research questions (Health-related questions, health behavior, medical equipment, treatments and therapies, quality of life, participation, social-economic factors, academic information, patient/caregiver reported outcomes, needs, concerns)

    0-80 years

Study Arms (1)

Patient population

Children, adolescents and adults diagnosed with a NMD (DMD/BMD/IMD; SMA; COL-6; LAMA-2) who are treated or living in Switzerland.

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All individuals living or treated in Switzerland with a diagnosis of a NMD. Currently, Spinal muscular atrophy, Duchenne muscular dystrophy, Merosin negative congenital muscular dystrophy MDC1A and Collagen 6 related muscular dystrophy are included. In the future, patients with other NMDs (e.g. Charcot-Marie-Tooth neuropathy, Myotonic Dystrophy or rare myopathies) may also be included if it appears relevant to clinicians and researchers active in the field of NMDs, patient organisations, and public health representatives.

You may qualify if:

  • Children, adolescents and adults diagnosed with a NMD
  • Who are living or treated for a NMD in Switzerland, and
  • Who gave informed consent

You may not qualify if:

  • None if diagnosis is confirmed, whenever possible, by genetic testing, or at least by biopsy and/or electroneuromyography, according to international standards for the diagnosis of the given NMD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Cantonal Hospital Aarau

Aarau, Canton of Aargau, Switzerland

RECRUITING

Pediatric Institute of Southern Switzerland, Ospedale San Giovanni

Bellinzona, Canton Ticino, Switzerland

RECRUITING

Neuro Centre of Italian Switzerland, Ospedale Regionale di Lugano

Lugano, Canton Ticino, Switzerland

RECRUITING

University Hospital Lausanne CHUV, Children's Hospital

Lausanne, Vaude, Switzerland

RECRUITING

University Hospital Lausanne CHUV

Lausanne, Vaude, Switzerland

RECRUITING

University Children's Hospital Basel

Basel, Switzerland

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

Inselspital Bern, Children's Hospital

Bern, Switzerland

RECRUITING

Inselspital Bern

Bern, Switzerland

RECRUITING

Institute of Social and Preventive Medicine (ISPM), University of Bern

Bern, Switzerland

RECRUITING

University Hospitals of Geneva, Children's Hospital

Geneva, Switzerland

RECRUITING

University Hospitals of Geneva

Geneva, Switzerland

RECRUITING

Cantonal Hospital of Lucerne LUKS

Lucerne, Switzerland

RECRUITING

Cantonal Hospital of Lucerne, LUKS

Lucerne, Switzerland

RECRUITING

Private Practice Alpenquai

Lucerne, Switzerland

RECRUITING

Cantonal Hospital of Eastern Switzerland

Sankt Gallen, Switzerland

RECRUITING

Children's Hospital of Eastern Switzerland

Sankt Gallen, Switzerland

RECRUITING

University Hospital Zuerich, Children's Hospital

Zurich, Switzerland

RECRUITING

University Hospital Zuerich

Zurich, Switzerland

RECRUITING

Related Links

Study Officials

  • Claudia E Kuehni, Prof. MD

    Institute of Social and Preventive Medicine (ISPM), University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia E Kuehni, Prof. MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
80 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

June 20, 2018

Primary Completion (Estimated)

January 1, 2071

Study Completion (Estimated)

January 1, 2071

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Researchers who wish to develop a nested study need to submit a proposal to the Swiss-Reg-NMD and request permission. A concept sheet describing the planned analyses must be approved by the Swiss-Reg-NMD Steering Board. Nested studies might need separate ethics permission.

Locations