drugset / Trial / NCT01760993

Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

NCT01760993 ↗

Phase 3 Terminated 2 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Timeline

Start
2013-02-01
Primary completion
2013-04-01
Completion
2013-04-01

Outcome

Outcome not reported

Stopped (Business): “Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Lisdexamfetamine Dimesylate Small molecule 40 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 80 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 100 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 120 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 140 mg Oral
Subject Lisdexamfetamine Dimesylate Small molecule 160 mg Oral

Indications