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MRI in Patients With Kennedy Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02501395
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Julia Dahlqvist, MD, Rigshospitalet, Denmark

Tracking Information
First Submitted Date July 14, 2015
First Posted Date July 17, 2015
Last Update Posted Date June 4, 2018
Study Start Date September 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2015)
Muscle fat fraction [ Time Frame: One MRI scan per subject (exam lasts approximately 60 min.) ]
The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02501395 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 15, 2015)
  • Muscle strength [ Time Frame: One muscle strength test per subject (exam lasts approximately 60 min.) ]
    Isokinetic muscle dynamometry will be used to measure muscle strength.
  • 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.) ]
    The 'minimal dataset for data collection in Kennedy disease' will be used to investigate the clinical spectrum of Kennedy disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title MRI in Patients With Kennedy Disease
Official Title MRI in Patients With Kennedy Disease
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
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.

Condition
  • Bulbo-Spinal Atrophy, X-Linked
  • Kennedy Disease
Intervention Other: No intervention, observational
Study Groups/Cohorts
  • Patients with Kennedy disease
    Men over 18 years old with confirmed Kennedy disease.
    Intervention: Other: No intervention, observational
  • Healthy, voluntary controls
    Gender and age matched healthy, voluntary controls.
    Intervention: Other: No intervention, observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 27, 2017)
53
Original Estimated Enrollment
 (submitted: July 15, 2015)
60
Actual Study Completion Date May 2018
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02501395
Other Study ID Numbers H-15006316
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Julia Dahlqvist, MD, Rigshospitalet, Denmark
Study Sponsor Rigshospitalet, Denmark
Collaborators Not Provided
Investigators
Principal Investigator: Julia R Dahlqvist, MD Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
PRS Account Rigshospitalet, Denmark
Verification Date June 2018