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Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease

NCT01751802 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-04-22

Study results available
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Summary

The purpose of this research study is to gather scientific information about the effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive substance) in subjects with Lesch-Nyhan Disease.

Conditions

  • Lesch-Nyhan Disease
  • Self-injurious Behavior

Interventions

DRUG

Ecopipam

Antagonist of the dopamine D1 receptor

DRUG

Placebo

Placebo for Ecopipam

Sponsors & Collaborators

  • Psyadon Pharma

    collaborator INDUSTRY

  • Emalex Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • H J Jinnah, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2014-12-31

Countries

  • United States
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01751802 on ClinicalTrials.gov