NCT01167439

Brief Summary

The investigators aimed to review the natural history of dysphagia and dysphonia in OPMD in order to identify the best candidates and the proper timing to perform dysphagia alleviating procedures in both heterozygote and homozygote patients from the large pool of cases with this disease in Israel.

Trial Health

55
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Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

July 22, 2010

Status Verified

December 1, 2009

Enrollment Period

2 years

First QC Date

July 21, 2010

Last Update Submit

July 21, 2010

Conditions

Dysphagia

Keywords

OPMD, dysphagiaDysphagia severityNutritional stateSpeech qualityUpper esophageal sphincter myotomy

Outcome Measures

Primary Outcomes (1)

  • Dysphagia, quality of life. Proper intervention timing in OPMD based on knowledge about the natural history of the feeding difficulty.

    Dysphagia, quality of life. Proper intervention timing in OPMD patients is very important and must be based on deep knowledge about the natural history of the feeding difficulty.

    at least 3 years

Study Arms (2)

Mild dysphagia

NO INTERVENTION

Severe dysphagia

ACTIVE COMPARATOR
Procedure: Upper esophageal sphincter myotomy

Interventions

Upper esophageal sphincter myotomyPROCEDURE

Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.

Severe dysphagia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • heterozygote and homozygote OPMD patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel National Center for OPMD and Dysphagia, HYMC

POB 169, Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

Deglutition DisordersMuscular Dystrophy, Oculopharyngeal

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesMuscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sergiu C. Blumen, MD

CONTACT

972-4-630-4262

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 22, 2010

Study Start

July 1, 2009

Primary Completion

July 1, 2011

Last Updated

July 22, 2010

Record last verified: 2009-12

Locations

IL(1)