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RecruitingNCT07146256Isr-OPMDUpdated Aug 28, 2025

Natural History of Oculo-Pharyngeal Muscular Dystrophy (OPMD) - Israel National OPMD Registry

An observational study in Oculopharyngeal Muscular Dystrophy (OPMD), sponsored by Sheba Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-28.

Sponsored by Sheba Medical Center · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study summary

The goal of this open prospective multi-disciplinary observational study of patients with OPMD at various stages of clinical manifestations is to explore the natural history of the disease in the Israeli population.

Read the detailed description

The the following procedures will be performed by a multidisciplinary team:

Neurological and neurocognitive examination; Clinical assessment of of swallowing and severity of dysphagia; Clinical assessment of eyelid ptosis severity; Clinical assessment of respiratory muscles function; Clinical assessment of oral health

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Conditions studied

  • Oculopharyngeal Muscular Dystrophy (OPMD)

Keywords

  • Oculopharyngeal muscular dystrophy (OPMD)
  • Natural history
  • Dysphagia
  • Eyelid ptosis
  • Muscle weakness
  • Oral health
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In context

Deglutition Disorders

871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.

This study's planned enrollment of 300 is above the median of 84 across 249 observational studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Genetically Confirmed Oculopharyngeal Muscular Dystrophy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with clinical diagnosis of OPMD or patients with signs /symptoms suggestive of OPMD

Exclusion criteria

Exclusion Criteria:

  • Age \<18 years and Pregnancy
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • Subjects with genetically diagnosed OPMD

    Other: Non-interventional observational study

Interventions

  • OtherNon-interventional observational study

    No intervention will be studied

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What researchers measure

Primary outcomes

  1. Severity of muscle strength decline over time

    10-meter walk test

    Time frame: 1 year

  2. Penetration/Aspiration Scale

    Penetration/Aspiration Scale (PAS)

    Time frame: 1 year

  3. Upper Margin Reflex Distance

    Upper Margin Reflex Distance

    Time frame: 1 year

  4. Lower Margin Reflex Distance

    Lower Margin Reflex Distance

    Time frame: 1 year

Secondary outcomes

  1. Maximum Expiratory Pressure

    Maximum Expiratory Pressure (MEP)

    Time frame: 2 years

  2. Cough Peak Flow

    Cough Peak Flow (CPF)

    Time frame: 2 years

  3. Oral health

    Decayed, Missing, and Filled Teeth (DMFT) index

    Time frame: 2 years

  4. Dysphagia severity

    Yale Pharyngeal Residue Severity Rating Scale

    Time frame: 1 year

  5. Functional Oral Intake Scale

    Functional Oral Intake Scale (FOIS)

    Time frame: 1 year

  6. Swallowing Disturbance

    Swallowing Disturbance Questionnaire (SDQ)

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Sheba Medical Center
    Ramat Gan, Israel
    Recruiting
    • Naama Study coordinator · ContactOPMD@sheba.health.gov.il · +972552929006
    • Amir Dori, MD, PhD · Principal investigator
    • Alex Zvulunov, MD, MHA · Sub investigator
    • Merav Ben-David, MD · Sub investigator
    • Limor Benyamini, MD · Sub investigator
    • Lior Greenbaum, MD, PhD · Sub investigator
    • Silvina Friedlander-Barenboim, DMD · Sub investigator
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07146256
Collaborators
The non-profit organization for promotion of health and cure of OPMD
Responsible party
Sponsor
First posted
Aug 28, 2025
Start date
Feb 1, 2022
Primary completion
Jan 2030 (estimated)
Completion
Jan 2030 (estimated)
Last update
Aug 28, 2025

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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