MRI in Patients With Kennedy Disease | NCT02501395

Studies
MRI in Patients With Kennedy Disease

NCT02501395

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Jun 4, 2018Actual

Enrollment

53Actual

Phase

Not provided

Conditions

Bulbo-Spinal Atrophy, X-Linked
Kennedy Disease

Interventions

No intervention, observational

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Feb 2017Actual

Completion Date

May 2018Actual

First Submitted Date

Jul 14, 2015

First Submission Date that Met QC Criteria

Jul 15, 2015

First Posted Date

Jul 17, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2018

Last Update Posted Date

Jun 4, 2018Actual

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with Kennedy disease		Men over 18 years old with confirmed Kennedy disease.	Other: No intervention, observational
Healthy, voluntary controls		Gender and age matched healthy, voluntary controls.	Other: No intervention, observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention, observational	Other		Healthy, voluntary controls Patients with Kennedy disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Muscle strength	Isokinetic muscle dynamometry will be used to measure muscle strength.	One muscle strength test per subject (exam lasts approximately 60 min.)
Minimal dataset for data collection in Kennedy disease

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Persons in Denmark diagnosed with Kennedy disease is invited to the study.

Gender and age matched controls will be recruited to a control group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julia R Dahlqvist, MD	Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen Neuromuscular Center		Copenhagen		2100	Denmark

Label	URL
The homepage of Copenhagen Neuromuscular Center, Denmark.	View source

Condition Browse Module

MeSH Terms

ID	Term
D055534	Bulbo-Spinal Atrophy, X-Linked

Ancestor Terms

ID	Term
D009134	Muscular Atrophy, Spinal
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided