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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03019458 |
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Date of registration:
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09/01/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
MINGO |
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Scientific title:
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MINGO Supplemental Trial in X-linked Dystonia Parkinsonism Patients: A Prospective Randomized, Open-labeled, Parallel Group Trial |
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Date of first enrolment:
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February 10, 2017 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03019458 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Criscely L Go, MD,FPNA,DPBP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Jose R. Reyes Memorial Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject is above the age of 18
- Positive Diagnosis of XDP by movement disorder specialist/fellow
- Subject with a yes response to a "supportive home environment" in the patient's most
recent "doctors monthly report"
- Subject are easily accessible to passable roads and pubic transportation
Exclusion Criteria:
- Subjects who have extreme movements that prevent staff from performing BMI or MUAC
measurements
- Subjects who have abnormal metabolic labs prior to the start of the study
- Subjects who are taking pharmacological or medicinal supplements that may effect
weight
- Subjects who have been hospitalized within the last 2 weeks from the start of the
trial
- Subjects who have a Nasogastric tube or G-tube
- Subjects with a history of other diseases that my effect weight (eg:
hypo/hyperthyroidism)
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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X-Linked Dystonia Parkinsonism
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Intervention(s)
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Dietary Supplement: MINGO
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Primary Outcome(s)
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The Body Mass Index (BMI in kg/m^2) Using a Bathroom Weighing Scale.
[Time Frame: after baseline Body Mass Index, we will measure Body Mass Index every 2 weeks for 3 months]
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Secondary Outcome(s)
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Number of Hospitalizations Secondary to Infectious Causes
[Time Frame: 3 months (study close out)]
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Mid Upper Arm Circumference (MUAC) in cm Using a Tailor's Tape Measure
[Time Frame: After baseline measurements, the investigators will measure the MUAC evey month for 3 months]
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All Cause Mortality
[Time Frame: 3 months (study close out)]
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Secondary ID(s)
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MINGO-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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