A Trial of Levodopa in Angelman Syndrome

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Angelman Syndrome

In brief

This study is designed to determine whether levodopa will lead to an improvement in the development and tremor in children with Angelman syndrome (AS). It has been suggested that levodopa, a medication that is usually used to treat Parkinson disease in adults, may help children with AS in their overall development and reduce the tremor that some of them have. If levodopa is found to be beneficial for children with AS, this could lead to a new treatment for AS. Funding Source - FDA-OOPD

Key facts

Study ID

NCT01281475

Run by

Wen-Hann Tan

People needed

67

Starts

2011-01-01

Expected to finish

2015-07-01

Last updated by the study team

2020-07-15

Who can join

Age: 4 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 4 years and 12 years (i.e., before the 13th birthday)
• Molecular confirmation of the diagnosis of AS, which may include abnormal methylation studies or UBE3A mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll
• Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation

You may not qualify if…

• Co-morbid disorders that may be associated with developmental or cognitive delays
• Poorly controlled seizures - An average of more than 2 clinical seizures per month in the 12 months prior to enrollment.
• Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months
• Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders
• Pregnancy

Where it is running

• Rady Children's Hospital, San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Greenwood Genetic Center — Greenwood, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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