Overview

This trial is active, not recruiting.

Conditions bulbo-spinal atrophy, x-linked, kennedy disease
Treatment no intervention, observational
Sponsor Rigshospitalet, Denmark
Start date September 2015
End date December 2016
Trial size 60 participants
Trial identifier NCT02501395, H-15006316

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
Men over 18 years old with confirmed Kennedy disease.
no intervention, observational
Gender and age matched healthy, voluntary controls.
no intervention, observational

Primary Outcomes

Measure
Muscle fat fraction
time frame: One MRI scan per subject (exam lasts approximately 60 min.)

Secondary Outcomes

Measure
Muscle strength
time frame: One muscle strength test per subject (exam lasts approximately 60 min.)
Minimal dataset for data collection in Kennedy disease
time frame: Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)

Eligibility Criteria

Male participants at least 18 years old.

Patients with Kennedy disease: Inclusion Criteria: - Confirmed Kennedy disease Exclusion Criteria: - All contraindications for undergoing an MRI scan Healthy controls Inclusion Criteria: - Fit age and gender criteria Exclusion Criteria: - All contraindications for undergoing an MRI scan

Additional Information

Official title MRI in Patients With Kennedy Disease
Principal investigator Julia R Dahlqvist, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.