CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
SPD489 (Lisdexamfetamine dimesylate) +1 moredrug
Likely dose
SPD489 (Lisdexamfetamine dimesylate) 50mgfrom 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/NCT01457339
NCT01457339Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia

Shire·interventional·Posted Oct 21, 2011·Updated Jun 3, 2021

In Brief

A Phase 1 clinical trial evaluating SPD489 (Lisdexamfetamine dimesylate) and Placebo for Schizophrenia. Completed, enrolled 31 participants across 2 sites.

Detailed Summary

This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2011
Enrollment StartOct 21, 2011
Primary CompletionJan 20, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.7 years ago

Interventions

SPD489 (Lisdexamfetamine dimesylate)drug

SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.

Placebodrug

Placebo Capsule(s) for oral use taken once daily for 30 days