CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Lorazepam +4 moredrug
Likely dose
Topiramate 100mgfrom 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/NCT01889602
NCT01889602Phase 4Completed

Characterizing and Predicting Drug Effects on Cognition

University of Minnesota·interventional·Posted Jun 28, 2013·Updated Dec 17, 2019

In Brief

A Phase 4 clinical trial evaluating Lorazepam, Placebo, and 3 other interventions for Cognitive Deficits. Completed, enrolled 60 participants across 1 site.

Detailed Summary

Cognitive impairment is a widely reported side effect of many commonly used drugs. Even a mild, untoward effect on an essential function such a linguistic behavior, a directly observable product of complex cognitive processes, is disruptive to daily life. Nevertheless, the mechanisms underlying a drug's impact on cognition are poorly understood. This lack of understanding impedes the ability to predict both the effects of drugs in development and the degree to which an individual is vulnerable to the cognitive impact of a particular agent. Topiramate (TPM, an antiepileptic drug) is, with increasing frequency, being prescribed for a range of conditions including migraine prophylaxis, obesity and pain. It is a prime example of a drug that causes speech and language problems severe enough in some patients to result in discontinuation of therapy. For reasons not well understood, TPM has a poorer cognitive profile than many of the older antiepileptic drugs. The investigators' rational for this study is that it will offer insight into the mechanisms underlying drug-induced cognitive deficits.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 28, 2013
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.0 years ago

Interventions

Lorazepamdrug

Lorazepam: 2mg, po, 1x

Placeboother

Non-active placebo, po, 1x

Topiramate 100mgdrug

Topiramate: 100 mg, po, 1x

Topiramate 150mgdrug

Topiramate: 150 mg, po, 1x

Topiramate 200mgdrug

Topiramate: 200 mg, po, 1x