Metachromatic LeukodystrophyNH-USNCT00639132
The Natural History of Metachromatic Leukodystrophy
An observational study of Metachromatic Leukodystrophy, run by University of Pittsburgh.
Trial summary
There have not been longitudinal studies which track patients' neurologically or developmentally in a systematic manner. By simultaneously tracking patients' neurodevelopment along with neuroimaging and neurophysiologic studies it becomes much easier to draw conclusions on the differential effects of the disease… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Metachromatic Leukodystrophy
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Mar 2008to 1 Feb 2022
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with biochemical evidence of MLD including low levels of arylsulphatase A white cell activity and increased amounts of urinary sulphatide excretion are eligible for the study. A total of 10 patients representing various ranges of disease severity are expected to enroll.
Who may be able to join
- The patient must have a confirmed diagnosis of MLD as defined by:
- ASA activity < 10 nmol/h/mg in leukocytes
- Presence of elevated sulfatide in urine
- The patient must have voluntary function (as judged by the investigator), including cognitive and motor function that is no more than 3 standard deviations below normal at the time of enrollment.
- The patient must have an age at the time of screening birth to < 6 years
- The patient must have had onset of symptoms before the age of 4 years
- The subject and his/her guardian(s) must have the ability to comply with the clinical protocol
Who cannot join
- Known multiple sulfatase deficiency
- Presence of major congenital abnormality
- Presence of known chromosomal abnormality and other neurological conditions unrelated to MLD that can affect psychomotor development
- History of hematopoietic stem cell transplantation
- Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition
- Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the principal investigator, would preclude participation in the trial
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- Use of any investigational product within 30 days prior to study enrollment or currently enrolled in another study which involves clinical investigations.
- The patient's parent(s) and/or legal guardian is unable to understand the nature, scope, and possible consequences of the study.
- Patient is unable to comply with the protocol, i.e. inability to return for follow-up evaluations or otherwise unlikely to complete the study as determined by the principal investigator.
About this study
There have not been longitudinal studies which track patients' neurologically or developmentally in a systematic manner. By simultaneously tracking patients' neurodevelopment along with neuroimaging and neurophysiologic studies it becomes much easier to draw conclusions on the differential effects of the disease process and any available treatments that patients might receive. In addition, many of the gene mutations, which cause MLD have not been linked to the age of onset or the expected disease course.
Read the detailed description
Metachromatic leukodystrophy (MLD), an autosomal recessively inherited lysosomal storage disorder, causes a deficiency of arylsulfatase A. This results in accumulation of sulfated glycolipids (sulphatide) within lysosomes of myelin forming cells in the central and peripheral nervous system and to a lesser extent in lysosomes of cells comprising the liver, kidneys, and gallbladder. The disease is characterized by progressive demyelination with wide variability in clinical onset and severity. Depending upon the age at onset and disease progression, MLD may be classified as late infantile (6 months to 4 years), early juvenile (4 to 6 years), late juvenile (6 to 16 years), and adult (>16 years). In the late infantile and early juvenile forms, blindness, gait disturbances, loss of speech, loss of hearing, and quadriparesis are common signs. In older children and adults the disease may present with gait disturbances, mental regression, and behavioral abnormalities. Disease progression, also variable, results in death within a few years to several decades; however, disease progression among affected siblings seems to follow a similar course, unlike many other leukodystrophies.
Bone marrow transplantation (BMT) has been the only partially effective treatment reported for MLD. BMT has been shown to halt disease progression when asymptomatic patients achieve engraftment prior to the age at which symptoms occurred in an affected, symptomatic sibling. Despite stabilization of the clinical course when receiving BMT before symptoms, patients' neurophysiologic test abnormalities persist. The clinical implication of this finding has not been further researched. Patients who show mild to moderate progression of their disease prior to transplantation continue to exhibit disease progression to severe impairment. However, specific degrees of clinical impairment in neurodevelopmental function have not been monitored to determine what level of cognitive and motor impairment can be present and still allow the patient to confer benefits from treatment. Patients with late infantile MLD appear to benefit the least from the transplantation process based on preliminary unpublished data. Several case report studies for patients with late infantile MLD indicate delayed, but continued progression of the disease despite BMT, while others suggest initial deterioration followed by stabilization.
Transplantation with allogenic hematopoietic stem cells has been shown to positively influence the disease progression of other lysosomal storage diseases such as Hurler Syndrome and Krabbe Disease and testing for enzyme replacement for MLD is already underway. For future researchers to be able compare the benefits of children with MLD who receive treatment to those who remained untreated, a better understanding of the natural progression of late infantile MLD is necessary. The current literature contains studies of individual or small groups of MLD patients that tracked intelligence quotients and neurophysiologic function, but did not correlate this with patients' neurodevelopment. A longitudinal study of a larger population of patients with late infantile MLD has yet to be performed. This protocol is a longitudinal observational study to capture natural history data in patients with late infantile MLD. This data will provide baseline neurobehavioral, neuroimaging, and neurophysiological information that can in the future be used to evaluate treatment effects.
- Conditions
- Metachromatic Leukodystrophy
- Keywords
- Natural History, Metachromatic Leukodystrophy, Disease Progression
- Medical subject headings
- Leukodystrophy, Metachromatic, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Results of cognitive and motor testing
Patients receive standardized neurodevelopmental testing Cognitive Motor Language
Measured: baseline, 6 months, 12 months and then yearly
Secondary outcomes (2)
Audiology
Audiologic examination
Measured: baseline, 6, 12, then yearly
MRI
Magnetic Resonance Imaging of the Brain
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study start11 Mar 2008
- Primary completion30 Jan 2022
- Study completion1 Feb 2022
Why it stopped: Merged with a broader study of rare diseases once moved to Pittsburgh
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metachromatic LeukodystrophyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Escolar, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639132
- Sponsor's protocol ID
- NH-US
- Acronym
- NH-US
- Status last verified
- May 2024
- First submitted
- 11 Mar 2008
- Last updated
- 30 May 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Metachromatic Leukodystrophy
- ClinicalTrials.gov ID
- NCT00639132
- Acronym / sponsor ID
- NH-US / NH-US
- Conditions
- Metachromatic Leukodystrophy
- Keywords
- Natural History, Metachromatic Leukodystrophy, Disease Progression
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Merged with a broader study of rare diseases once moved to Pittsburgh
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 11 Mar 2008 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 19 Mar 2008 (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.
There have not been longitudinal studies which track patients' neurologically or developmentally in a systematic manner. By simultaneously tracking patients' neurodevelopment along with neuroimaging and neurophysiologic studies it becomes much easier to draw conclusions on the differential effects of the disease process and any available treatments that patients might receive. In addition, many of the gene mutations, which cause MLD have not been linked to the age of onset or the expected disease course.
Detailed description
Metachromatic leukodystrophy (MLD), an autosomal recessively inherited lysosomal storage disorder, causes a deficiency of arylsulfatase A. This results in accumulation of sulfated glycolipids (sulphatide) within lysosomes of myelin forming cells in the central and peripheral nervous system and to a lesser extent in lysosomes of cells comprising the liver, kidneys, and gallbladder. The disease is characterized by progressive demyelination with wide variability in clinical onset and severity. Depending upon the age at onset and disease progression, MLD may be classified as late infantile (6 months to 4 years), early juvenile (4 to 6 years), late juvenile (6 to 16 years), and adult (>16 years). In the late infantile and early juvenile forms, blindness, gait disturbances, loss of speech, loss of hearing, and quadriparesis are common signs. In older children and adults the disease may present with gait disturbances, mental regression, and behavioral abnormalities. Disease progression, also variable, results in death within a few years to several decades; however, disease progression among affected siblings seems to follow a similar course, unlike many other leukodystrophies.
Bone marrow transplantation (BMT) has been the only partially effective treatment reported for MLD. BMT has been shown to halt disease progression when asymptomatic patients achieve engraftment prior to the age at which symptoms occurred in an affected, symptomatic sibling. Despite stabilization of the clinical course when receiving BMT before symptoms, patients' neurophysiologic test abnormalities persist. The clinical implication of this finding has not been further researched. Patients who show mild to moderate progression of their disease prior to transplantation continue to exhibit disease progression to severe impairment. However, specific degrees of clinical impairment in neurodevelopmental function have not been monitored to determine what level of cognitive and motor impairment can be present and still allow the patient to confer benefits from treatment. Patients with late infantile MLD appear to benefit the least from the transplantation process based on preliminary unpublished data. Several case report studies for patients with late infantile MLD indicate delayed, but continued progression of the disease despite BMT, while others suggest initial deterioration followed by stabilization.
Transplantation with allogenic hematopoietic stem cells has been shown to positively influence the disease progression of other lysosomal storage diseases such as Hurler Syndrome and Krabbe Disease and testing for enzyme replacement for MLD is already underway. For future researchers to be able compare the benefits of children with MLD who receive treatment to those who remained untreated, a better understanding of the natural progression of late infantile MLD is necessary. The current literature contains studies of individual or small groups of MLD patients that tracked intelligence quotients and neurophysiologic function, but did not correlate this with patients' neurodevelopment. A longitudinal study of a larger population of patients with late infantile MLD has yet to be performed. This protocol is a longitudinal observational study to capture natural history data in patients with late infantile MLD. This data will provide baseline neurobehavioral, neuroimaging, and neurophysiological information that can in the future be used to evaluate treatment effects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with biochemical evidence of MLD including low levels of arylsulphatase A white cell activity and increased amounts of urinary sulphatide excretion are eligible for the study. A total of 10 patients representing various ranges of disease severity are expected to enroll.
Key inclusion criteria (7 listed)
- The patient must have a confirmed diagnosis of MLD as defined by:
- ASA activity < 10 nmol/h/mg in leukocytes
- Presence of elevated sulfatide in urine
- The patient must have voluntary function (as judged by the investigator), including cognitive and motor function that is no more than 3 standard deviations below normal at the time of enrollment.
- The patient must have an age at the time of screening birth to < 6 years
Key exclusion criteria (9 listed)
- Known multiple sulfatase deficiency
- Presence of major congenital abnormality
- Presence of known chromosomal abnormality and other neurological conditions unrelated to MLD that can affect psychomotor development
- History of hematopoietic stem cell transplantation
- Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Results of cognitive and motor testing
Time frame: baseline, 6 months, 12 months and then yearly
Patients receive standardized neurodevelopmental testing Cognitive Motor Language
2 secondary outcomes
Audiology
Time frame: baseline, 6, 12, then yearly
MRI
Time frame: yearly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Metachromatic Leukodystrophy, run by University of Pittsburgh.
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 7 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Results of cognitive and motor testing (time frame: baseline, 6 months, 12 months and then yearly). 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 30 May 2024.