Chronic Progressive External OphthalmoplegiaCPEONCT02161848
MRI Study - Chronic Progressive External Ophthalmoplegia
An observational study of Chronic Progressive External Ophthalmoplegia, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag muscles, thighs and calves in patients with the mitochondrial disease chronic progressive external ophthalmoplegia (CPEO). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Progressive External Ophthalmoplegia
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 133 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2014to Oct 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.
Who may be able to join
- Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.
Who cannot join
- Patients who have metal implants in the body, for instance surgical clips, cochlear implant, pacemaker etc.
- Patients who are pregnant or breast-feeding.
- Patients who are claustrophobic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Imaging Study of Patients With Chronic Progressive External Ophthalmoplegia
The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag muscles, thighs and calves in patients with the mitochondrial disease chronic progressive external ophthalmoplegia (CPEO).
Additionally an investigation of the volume of the eye muscles will be done and compared to the patient's clinical presentation of ptosis and ophthalmoplegia.
Read the detailed description
The lack of energy and fatigue seen in patients with mitochondrial diseases have been assumed to be caused by an energy defect because of a genetic defect in the mitochondrial DNA.
The investigators have analyzed a few MRI scans of muscles from patients with CPEO and have seen an extended amount of fat in their muscles, which seems to progress with age. The patient's symptoms might be caused by the extended amount of fat and thereby a less amount of active muscle instead of the "energy defect".
This will be investigated in a group of patients with CPEO and the results will be compared with results from a group of healthy controls.
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Ophthalmoplegia, Chronic Progressive External
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
MRI of eye muscles, lower bag muscles, thigh muscles and calf muscles.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with verified singe large-scale mtDNA deletions and chronic progressive external ophthalmoplegia. Receives: Other: Magnetic Resonance Imaging | |
| Controls | Healthy controls matched for age and gender. Receives: Other: Magnetic Resonance Imaging | |
| Patient group as Controls | Patients with mitochondrial DNA 3243A>G mutations Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat fraction in the muscles of the lower bag, thighs and calves
The investigators will make a 3-point Dixon scan of the muscles of the lower bag, thighs and calves and measure the fraction of fat in these muscles once per patient or control.
Measured: 1 day
Secondary outcomes (4)
Isokinetic muscle dynamometry of ankle flexion
Isokinetic muscle dynamometry of ankle flexion. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.
Measured: 1 day
Isokinetic muscle dynamometry of ankle extension
Isokinetic muscle dynamometry of ankle extension. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.
Measured: 1 day
Isokinetic muscle dynamometry of knee flexion.
Isokinetic muscle dynamometry of knee flexion. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.
Measured: 1 day
Isokinetic muscle dynamometry of knee extension
Isokinetic muscle dynamometry of knee extension. This is made on a Biodex 3 and done once per patient or control the same day as the MRI-scan is done. These results are correlated with the amount of non-fat-infiltrated muscle on the MRI scans.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Progressive External OphthalmoplegiaStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Hedermann Pedersen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161848
- Sponsor's protocol ID
- H-3-2012-163 (CPEO)
- Acronym
- CPEO
- Status last verified
- Apr 2016
- First submitted
- 6 Jun 2014
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Study of Patients With Chronic Progressive External Ophthalmoplegia
- ClinicalTrials.gov ID
- NCT02161848
- Acronym / sponsor ID
- CPEO / H-3-2012-163 (CPEO)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 12 Jun 2014 (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.
The purpose of this study is to investigate the fraction of fat on a MRI scan of lower bag muscles, thighs and calves in patients with the mitochondrial disease chronic progressive external ophthalmoplegia (CPEO).
Additionally an investigation of the volume of the eye muscles will be done and compared to the patient's clinical presentation of ptosis and ophthalmoplegia.
Detailed description
The lack of energy and fatigue seen in patients with mitochondrial diseases have been assumed to be caused by an energy defect because of a genetic defect in the mitochondrial DNA.
The investigators have analyzed a few MRI scans of muscles from patients with CPEO and have seen an extended amount of fat in their muscles, which seems to progress with age. The patient's symptoms might be caused by the extended amount of fat and thereby a less amount of active muscle instead of the "energy defect".
This will be investigated in a group of patients with CPEO and the results will be compared with results from a group of healthy controls.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Magnetic Resonance ImagingPatients with verified singe large-scale mtDNA deletions and chronic progressive external ophthalmoplegia. |
| Controls | – | Other: Magnetic Resonance ImagingHealthy controls matched for age and gender. |
| Patient group as Controls | – | Other: Magnetic Resonance ImagingPatients with mitochondrial DNA 3243A>G mutations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.
Key inclusion criteria (1 listed)
- Danish patients with verified single large-scale mtDNA deletions and chronic progressive external ophthalmoplegia.
Key exclusion criteria (3 listed)
- Patients who have metal implants in the body, for instance surgical clips, cochlear implant, pacemaker etc.
- Patients who are pregnant or breast-feeding.
- Patients who are claustrophobic
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 |
|---|---|---|
| Magnetic Resonance ImagingMRI of eye muscles, lower bag muscles, thigh muscles and calf muscles. | Other | Controls, Patient group as Controls, Patients |
Primary outcome
Fat fraction in the muscles of the lower bag, thighs and calves
Time frame: 1 day
The investigators will make a 3-point Dixon scan of the muscles of the lower bag, thighs and calves and measure the fraction of fat in these muscles once per patient or control.
4 secondary outcomes
Isokinetic muscle dynamometry of ankle flexion
Time frame: 1 day
Isokinetic muscle dynamometry of ankle extension
Time frame: 1 day
Isokinetic muscle dynamometry of knee flexion.
Time frame: 1 day
Isokinetic muscle dynamometry of knee extension
Time frame: 1 day
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 14 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Progressive External Ophthalmoplegia, 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 1 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 14 Apr 2016. 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?
Fat fraction in the muscles of the lower bag, thighs and calves (time frame: 1 day). 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 14 Apr 2016.