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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: |
NCT03235037 |
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Date of registration:
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28/07/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clinical Trial of Levodopa/Carbidopa ( Sinemet) Therapy in Angel Man Syndrome
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Scientific title:
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Clinical Trial of Levodopa/Carbidopa ( Sinemet) Therapy in Angel Man Syndrome |
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Date of first enrolment:
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November 26, 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03235037 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Contacts
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Name:
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Bennett Lavenstein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's National Health System, Department of Neurology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of Angelman syndrome confirmed by molecular genetic testing.
- Age between 18 months and 16 years of age
- Absence of any contraindication to the use of Sinemet as determined by the PI
Exclusion Criteria:
- Intractable epilepsy not responsive to anticonvulsive therapy in the patient with this
syndrome.
- History of prior drug intolerances/drug hypersensitivity to any agent that may be
similar to L Dopa .
- Progressively deteriorating EEG pattern.
Age minimum:
18 Months
Age maximum:
16 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Angelman Syndrome
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Intervention(s)
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Drug: Levodopa
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Primary Outcome(s)
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Improvement in motor control determined through composite measure- SARA score
[Time Frame: 2 years]
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Improvement in motor control determined through composite measure- Tremor
[Time Frame: 2 years]
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Improvement in motor control determined through composite measure-Ataxia
[Time Frame: 2 years]
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Secondary Outcome(s)
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Improvement in development determined through composite measure-Psychoeducational Testing
[Time Frame: 2 years]
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Secondary ID(s)
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IRB PRO00004116
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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