MRI in Patients With Kennedy Disease

NCT ID: NCT02501395

Last Updated: 2018-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-05-31

Brief Summary

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Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.

The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.

Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.

Detailed Description

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Conditions

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Bulbo-Spinal Atrophy, X-Linked Kennedy Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Kennedy disease

Men over 18 years old with confirmed Kennedy disease.

No intervention, observational

Intervention Type OTHER

Healthy, voluntary controls

Gender and age matched healthy, voluntary controls.

No intervention, observational

Intervention Type OTHER

Interventions

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No intervention, observational

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Confirmed Kennedy disease


* Fit age and gender criteria

Exclusion Criteria

* All contraindications for undergoing an MRI scan

Healthy controls


* All contraindications for undergoing an MRI scan
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Julia Dahlqvist, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia R Dahlqvist, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University

Locations

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Copenhagen Neuromuscular Center

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://neuromuscular.dk

The homepage of Copenhagen Neuromuscular Center, Denmark.

Other Identifiers

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H-15006316

Identifier Type: -

Identifier Source: org_study_id

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