CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Atomoxetine +1 moredrug
Likely dose
Atomoxetine 80mgfrom 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/NCT01738191
NCT01738191Phase 2Completed
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Atomoxetine Treatment for Cognitive Impairment in Parkinson's Disease (ATM-Cog)

Medical University of South Carolina·interventional·Posted Nov 30, 2012·Updated Aug 23, 2018

In Brief

A Phase 2 clinical trial evaluating Atomoxetine and Placebo for Parkinson's Disease and Cognitive Impairment. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and effectiveness of a drug called atomoxetine for the treatment of cognitive impairment for Parkinson 's disease. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease, Cognitive Impairment
CountriesUnited States
CollaboratorsMichael J. Fox Foundation for Parkinson's Research

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2012
Enrollment StartNov 1, 2012
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.6 years ago

Interventions

Atomoxetinedrug

The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.

Placebodrug