CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 5 enrolled
Drug / intervention
Ecopipamdrug
Likely dose
Ecopipam 200 mgfrom 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/NCT01065558
NCT01065558Phase 1Completed
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A Safety and Pilot Activity Study of Ecopipam (PSYRX 101) in the Symptomatic Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease

Psyadon Pharma·interventional·Posted Feb 9, 2010·Updated Apr 18, 2013

In Brief

A Phase 1 clinical trial evaluating Ecopipam for Lesch-Nyhan Disease. Completed, enrolled 5 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine the effects of ecopipam in patients with Lesch-Nyhan Disease (LND). Ecopipam specifically blocks the actions of one chemical in the brain that helps nerves talk to one another; ecopipam does this by stopping the chemical (dopamine) from binding to one of its family of receptors (i.e, the D1 family). LND is a very rare genetic disease. The sponsor is doing this study to find out what side effects ecopipam causes in LND patients, and whether ecopipam may be able to relieve the self-injurious behaviors seen in these patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLesch-Nyhan Disease
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 9, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJan 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.4 years ago

Interventions

Ecopipamdrug

Tablets, once daily, for two weeks up to 200 mg/day