CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Levodopa/Carbidopa (4:1)drug
Likely dose
Levodopa/Carbidopa (4:1) 15 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00829439
NCT00829439Phase 1Completed
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A Dose-escalation Tolerability Study of Levodopa/Carbidopa in Angelman Syndrome

Boston Children's Hospital·interventional·Posted Jan 27, 2009·Updated Nov 21, 2016

In Brief

A Phase 1 clinical trial evaluating Levodopa/Carbidopa (4:1) for Angelman Syndrome. Completed, enrolled 16 participants across 1 site.

Detailed Summary

This study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with Angelman syndrome. It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and abnormal movements (e.g. tremors) in children with Angelman syndrome. Data from this study will be used to design a phase II trial to determine the efficacy of levodopa in treating children with Angelman syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAngelman Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 27, 2009
Enrollment StartJan 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.4 years ago

Interventions

Levodopa/Carbidopa (4:1)drug

Dosages are based on levodopa. Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose. Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.