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NCT Number: NCT07146256

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

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.

Recruiting

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Key information

Conditions

Oculopharyngeal Muscular Dystrophy (OPMD) Blepharoptosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deglutition Disorders Digestive System Diseases Esophageal Diseases Eye Diseases Eyelid Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Muscle Weakness Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Oculopharyngeal Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Neuromuscular Manifestations Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba Medical Center

Ramat Gan, Israel

Location status: Recruiting

Location contact

Alex Zvulunov, MD, MHA

SUB_INVESTIGATOR

Amir Dori, MD, PhD

PRINCIPAL_INVESTIGATOR

Limor Benyamini, MD

SUB_INVESTIGATOR

Lior Greenbaum, MD, PhD

SUB_INVESTIGATOR

Merav Ben-David, MD

SUB_INVESTIGATOR

Naama Study coordinator

CONTACT

[email protected]

+972552929006

Silvina Friedlander-Barenboim, DMD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age <18 years and Pregnancy

Treatment and study plan

Non-interventional observational study

Other

No intervention will be studied

Primary outcomes

  1. Severity of muscle strength decline over time

    Time frame: 1 year

    10-meter walk test

  2. Penetration/Aspiration Scale

    Time frame: 1 year

    Penetration/Aspiration Scale (PAS)

  3. Upper Margin Reflex Distance

    Time frame: 1 year

    Upper Margin Reflex Distance

  4. Lower Margin Reflex Distance

    Time frame: 1 year

    Lower Margin Reflex Distance

Secondary outcomes

  1. Maximum Expiratory Pressure

    Time frame: 2 years

    Maximum Expiratory Pressure (MEP)

  2. Cough Peak Flow

    Time frame: 2 years

    Cough Peak Flow (CPF)

  3. Oral health

    Time frame: 2 years

    Decayed, Missing, and Filled Teeth (DMFT) index

  4. Dysphagia severity

    Time frame: 1 year

    Yale Pharyngeal Residue Severity Rating Scale

  5. Functional Oral Intake Scale

    Time frame: 1 year

    Functional Oral Intake Scale (FOIS)

  6. Swallowing Disturbance

    Time frame: 1 year

    Swallowing Disturbance Questionnaire (SDQ)

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Collaborators

  • The non-profit organization for promotion of health and cure of OPMD

Registry information

Acronym: Isr-OPMD

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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