MRI in Patients With Kennedy Disease

Kennedy Disease Clinical Trial

Official title:

MRI in Patients With Kennedy Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501395
• Other study ID #: H-15006316
• Status: Completed
• Start date: September 2015
• Est. completion date: May 2018

Study information

• Verified date: June 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Bulbo-Spinal Atrophy, X-Linked
• Kennedy Disease

Intervention

Other:
• No intervention, observational

Locations

Country	Name	City	State
Denmark	Copenhagen Neuromuscular Center	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle fat fraction	The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.	One MRI scan per subject (exam lasts approximately 60 min.)
Secondary	Muscle strength	Isokinetic muscle dynamometry will be used to measure muscle strength.	One muscle strength test per subject (exam lasts approximately 60 min.)
Secondary	Minimal dataset for data collection in Kennedy disease	The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease.	Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)

External Links

•   The homepage of Copenhagen Neuromuscular Center, Denmark.