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NCT01889602 · ClinicalTrials.gov registry record · Phase 4
Characterizing and Predicting Drug Effects on Cognition
A Phase 4 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT01889602 is a Phase 4 study that has completed, run by University of Minnesota. The registered enrollment target is 60 participants.
The verdict
NCT01889602, a Phase 4 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Lorazepam
- DRUG Topiramate 100mg
- DRUG Topiramate 150mg
- DRUG Topiramate 200mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01889602
The ClinicalTrials.gov registry entry for NCT01889602 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01889602 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01889602 about?
NCT01889602 is a clinical study titled "Characterizing and Predicting Drug Effects on Cognition". 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 dr...
What is the current status of trial NCT01889602?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2013-07. Estimated completion is 2016-08.
What interventions are being tested in trial NCT01889602?
The interventions under investigation include: Placebo (OTHER), Lorazepam (DRUG), Topiramate 100mg (DRUG), Topiramate 150mg (DRUG), Topiramate 200mg (DRUG).
Who is sponsoring clinical trial NCT01889602?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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