CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate (LDX) +2 moredrug
Likely dose
Not stated in 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/NCT01010750
NCT01010750Phase 1Completed
CompareCT.gov

A Phase I, Randomized, Double Blind, Three-Period Crossover, Estimation Study Using Lisdexamfetamine Dimesylate, Immediate Release Mixed Amphetamine Salts and Placebo to Evaluate the Utility of a Standardized Computer Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

Shire·interventional·Posted Nov 10, 2009·Updated Jun 14, 2021

In Brief

A Phase 1 clinical trial evaluating Lisdexamfetamine Dimesylate (LDX), Immediate Release Mixed Amphetamine Salts (MAS-IR), and 1 other intervention for Attention-Deficit Hyperactivity Disorder. Completed, enrolled 18 participants across 1 site.

Detailed Summary

To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAttention-Deficit Hyperactivity Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2009
Enrollment StartJan 5, 2010
Primary CompletionMar 28, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 16.6 years ago

Interventions

Lisdexamfetamine Dimesylate (LDX)drug

Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo

Immediate Release Mixed Amphetamine Salts (MAS-IR)drug

Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo

LDX Placebo + MAS-IR Placebodrug

Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo