Phase 4
N=60
Characterizing and Predicting Drug Effects on Cognition
Cognitive Deficits
Bottom Line
View on ClinicalTrials.gov: NCT01889602 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Change From Baseline in COWA Unique Word Count — -0.407725385; -0.425898667; -0.412534118; -0.108298333 Word Count
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lorazepam (Drug); Placebo (Other); Topiramate 100mg (Drug); Topiramate 150mg (Drug); Topiramate 200mg (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in COWA Unique Word Count |
-0.407725385; -0.425898667; -0.412534118; -0.108298333; 0.131452143; -0.095221176 | — |
| PRIMARY Change From Baseline in Spontaneous Narrative Raw Word Count |
-0.01596; -0.131732; -0.323135625; 0.109636; 0.016635385; -0.128177333 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy men and women
- Ages 18-50
- Women are post-menopausal or using approved birth control methods
- To control for brain lateralization of language functions, subjects need to have a dominant right hand.
Exclusion Criteria
- Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, renal, neurologic, and/or psychiatric disease including suicidality
- Vision or hearing impairments
- Current or a history of drug or alcohol abuse
- living outside of the Twin Cities Metropolitan area.
- The use of concomitant medications known to affect Topiramate (TPM), Lorazepam (LZP), or the use of any concomitant medications that may alter cognitive function
- Prior adverse reaction or prior hypersensitivity to TPM, LZP or related compounds
- A positive pregnancy test (administered to all women before enrollment, and prior to each study session).
- Subjects who have received any investigational drug within the previous 30 days
Data sourced from ClinicalTrials.gov (NCT01889602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.