Bulbo-Spinal Atrophy, X-LinkedNCT02501395
MRI in Patients With Kennedy Disease
An observational study of Bulbo-Spinal Atrophy, X-Linked and Kennedy Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bulbo-Spinal Atrophy, X-Linked, Kennedy Disease
- How many people
- 53 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2015to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Confirmed Kennedy disease
- Fit age and gender criteria
Who cannot join
- All contraindications for undergoing an MRI scan
- Healthy controls
- All contraindications for undergoing an MRI scan
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bulbo-Spinal Atrophy, X-Linked, Kennedy Disease
- Being tested
- No intervention, observational
- Medical subject headings
- Bulbo-Spinal Atrophy, X-Linked
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, observationalOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with Kennedy disease | Men over 18 years old with confirmed Kennedy disease. Receives: Other: No intervention, observational | |
| Healthy, voluntary controls | Gender and age matched healthy, voluntary controls. Receives: Other: No intervention, observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fat fraction
The Dixon MRI will be used to quantify the fat fraction in skeletal muscle.
Measured: One MRI scan per subject (exam lasts approximately 60 min.)
Secondary outcomes (2)
Muscle strength
Isokinetic muscle dynamometry will be used to measure muscle strength.
Measured: One muscle strength test per subject (exam lasts approximately 60 min.)
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.
Measured: Data will be collected once for patients with Kennedy disease (exam lasts approximately 90 min.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2017
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulbo-Spinal Atrophy, X-LinkedStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Dahlqvist, MD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Julia R Dahlqvist, MD, Principal investigator, Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501395
- Sponsor's protocol ID
- H-15006316
- Status last verified
- Jun 2018
- First submitted
- 14 Jul 2015
- Last updated
- 4 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI in Patients With Kennedy Disease
- ClinicalTrials.gov ID
- NCT02501395
- Acronym / sponsor ID
- H-15006316
- Conditions
- Bulbo-Spinal Atrophy, X-Linked, Kennedy Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Kennedy disease | – | Other: No intervention, observationalMen over 18 years old with confirmed Kennedy disease. |
| Healthy, voluntary controls | – | Other: No intervention, observationalGender and age matched healthy, voluntary controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Confirmed Kennedy disease
- Fit age and gender criteria
Key exclusion criteria (3 listed)
- All contraindications for undergoing an MRI scan
- Healthy controls
- All contraindications for undergoing an MRI scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, observational | Other | Healthy, voluntary controls, Patients with Kennedy disease |
Primary outcome
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.
2 secondary outcomes
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.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- The homepage of Copenhagen Neuromuscular Center, Denmark.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia R Dahlqvist, MD principal investigator
Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, Copenhagen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bulbo-Spinal Atrophy, X-Linked and Kennedy Disease, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fat fraction (time frame: One MRI scan per subject (exam lasts approximately 60 min.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.