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Clinical Trial NCT07146256 (Isr-OPMD) for Oculopharyngeal Muscular Dystrophy (OPMD) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Sheba Medical CenterNatural History of Oculo-Pharyngeal Muscular Dystrophy (OPMD) - Israel National OPMD Registry (Isr-OPMD) 300 Observational
Clinical Trial NCT07146256 (Isr-OPMD) is an observational study for Oculopharyngeal Muscular Dystrophy (OPMD) that is recruiting. It started on 1 February 2022 with plans to enroll 300 participants. Led by Sheba Medical Center, it is expected to complete by 1 January 2030. The latest data from ClinicalTrials.gov was last updated on 28 August 2025.
Brief 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.
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
Official Title
Natural History of Oculo-Pharyngeal Muscular Dystrophy (OPMD) - Israel National OPMD Registry
Conditions
Oculopharyngeal Muscular Dystrophy (OPMD)Other Study IDs
- Isr-OPMD
- SHEBA-21-8801-AD-CTIL
NCT ID Number
Start Date (Actual)
2022-02-01
Last Update Posted
2025-08-28
Completion Date (Estimated)
2030-01
Enrollment (Estimated)
300
Study Type
Observational
Status
Recruiting
Keywords
Oculopharyngeal muscular dystrophy (OPMD)
Natural history
Dysphagia
Eyelid ptosis
Muscle weakness
Oral health
Natural history
Dysphagia
Eyelid ptosis
Muscle weakness
Oral health
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Subjects with genetically diagnosed OPMD | Non-interventional observational study No intervention will be studied |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Severity of muscle strength decline over time | 10-meter walk test | 1 year |
Penetration/Aspiration Scale | Penetration/Aspiration Scale (PAS) | 1 year |
Upper Margin Reflex Distance | Upper Margin Reflex Distance | 1 year |
Lower Margin Reflex Distance | Lower Margin Reflex Distance | 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Maximum Expiratory Pressure | Maximum Expiratory Pressure (MEP) | 2 years |
Cough Peak Flow | Cough Peak Flow (CPF) | 2 years |
Oral health | Decayed, Missing, and Filled Teeth (DMFT) index | 2 years |
Dysphagia severity | Yale Pharyngeal Residue Severity Rating Scale | 1 year |
Functional Oral Intake Scale | Functional Oral Intake Scale (FOIS) | 1 year |
Swallowing Disturbance | Swallowing Disturbance Questionnaire (SDQ) | 1 year |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Patients with clinical diagnosis of OPMD or patients with signs /symptoms suggestive of OPMD
- Age <18 years and Pregnancy
Sheba Medical CenterThe non-profit organization for promotion of health and cure of OPMDNo contact data.
1 Study Locations in 1 Countries
Sheba Medical Center, Ramat Gan, Israel
Naama Study coordinator, Contact, +972552929006, [email protected]
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
Recruiting