Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 65 |
| Updated: | 3/30/2013 |
| Start Date: | February 2010 |
| End Date: | June 2011 |
A Safety and Pilot Activity Study of Ecopipam (PSYRX 101) in the Symptomatic Treatment of Self-Injurious Behavior in Subjects 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 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.
Inclusion Criteria
- Diagnosis of Lesch-Nyhan disease with moderate to severe Self- Injurious
Behavior and are routinely restrained
- Male - 6 years of age and above
- Body weight greater than or equal to 44 pounds
Exclusion Criteria:
- Taking Neuroleptic or Dopamine Depleting medications
- Currently treated with medications for depression or seizures
- Impaired renal function
- Medical conditions that may interfere with completing the study
We found this trial at
2
sites
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