Physiologic Effects of Topiramate on Cognition

NCT02884050 | Completed Phase 1

• 1 other identifier: 96-2009
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief Summary

Data generated from this pilot project will be used to support a larger, NIH funded study to investigate the physiologic mechanisms associated with the cognitive side effects of a commonly prescribed antiepileptic drug (AED), topiramate (TPM). This study will provide pilot data to 1) demonstrate the viability of using quantitative electroencephalogram (EEG) to examining physiological effects of AEDs as they relate to language function, and 2) perform formal power estimate calculations in support of a longer-term connectivity study using stochastic modeling techniques including power, coherence, and Granger causality metrics to analyze AED effects on quantitative EEG. Traditionally, the cognitive side effects of AEDs have been considered a byproduct of decreased neuronal excitation associated with medical therapy, although recent data suggests that this may not be true for some newer medications, such as TPM. The proposed experiments will employ quantitative EEG to investigate the effects of topiramate on neuronal network connectivity and pharmacokinetic/pharmacogenetic relationships in order to explore individual physiological responses. Topiramate is selected because of its relatively unique effects on generative verbal fluency, but unlike older AEDs, TPM is associated with little EEG change. The investigators will compare the effects of TPM to baseline and an inactive placebo in a randomized double blind crossover design.

Conditions

Alteration of Cognitive Function

Outcome Measures

Primary Outcomes (1)

• Controlled Oral Word Association test

  generative verbal fluency

  6 hours

Study Arms (2)

Topiramate

EXPERIMENTAL

single, 100mg oral dose of topiramate

Drug: Topiramate

Placebo

PLACEBO COMPARATOR

matched inactive placebo

Drug: Placebo

Interventions

Topiramate DRUG

antiepilepsy drug

Also known as: Topamax

Topiramate

Placebo DRUG

non-active placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women (post menopausal or using approved birth control methods

You may not qualify if:

• Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease
• Presence or history of drug or alcohol abuse
• The use of concomitant medications which are known to affect topiramate or the use of any concomitant medications that may alter cognitive function, including antidepressants, anxiolytics, psychostimulants such Ritalin, prescribed analgesics, and antipsychotics.
• Prior adverse reaction to or prior hypersensitivity to topiramate or to related compounds
• Subjects who have received any investigational drug within the previous thirty days

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Interventions

Topiramate

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 30, 2016
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: January 11, 2017

Record last verified: 2017-01