Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01065558 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
A Phase 1 study of Lesch-Nyhan Disease, sponsored by Psyadon Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 2
- Study locations
NCT01065558: Completed Phase 1 study of Lesch-Nyhan Disease, sponsored by Psyadon Pharma.
NCT01065558 is a Phase 1 study of Lesch-Nyhan Disease that has completed, run by Psyadon Pharma. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01065558, a Phase 1 study of Lesch-Nyhan Disease, has completed, sponsored by Psyadon Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
This study's primary outcome is the safety of ecopipam in Lesch-Nyhan patients as measured by standard clinical laboratory tests. The patients will also be observed and questioned about other side effects, such as whether they feel more or less tired.Standard clinical laboratory tests for liver, kidney and blood function were conducted. The normal ranges for each of these tests were different and are too numerous to be individually listed here. However, if any individual value were to be either
Conditions Studied
Interventions
- DRUG Ecopipam
Study Locations (2)
California
- University of California at San Diego - San Diego
Georgia
- Emory Univesity - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-06 |
| Phase | Phase 1 |
What the finished NCT01065558 record still lists
NCT01065558 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Lesch-Nyhan Disease appearing as the primary indexed condition, and to 1 intervention - of which Ecopipam is the first listed.
NCT01065558 reports a single indexed study location in California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01065558 about?
NCT01065558 is a clinical study titled "Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease". 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...
What is the current status of trial NCT01065558?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2010-02. Estimated completion is 2011-06.
What conditions does trial NCT01065558 study?
This clinical trial studies the following conditions: Lesch-Nyhan Disease.
What interventions are being tested in trial NCT01065558?
The interventions under investigation include: Ecopipam (DRUG).
Who is sponsoring clinical trial NCT01065558?
This trial is sponsored by Psyadon Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01065558 being conducted?
This trial has 2 study locations across California, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01065558's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia