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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: Completed Phase 4 study, sponsored by University of Minnesota.
NCT01889602 is a Phase 4 study that has completed, run by University of Minnesota. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Study has 3 arms (100mg, 150mg, or 200mg topiramate) and 3 periods per arm (topiramate, 2mg lorazepam, or placebo). Topiramate (TPM), Lorazepam (LZP), or Placebo (PLA) was given to the participant at the beginning of Sessions 2, 3, and 4 (crossover design). No drug was given at Sessions 1 and 5. The baseline value was defined as the average of the values at Session 1 and Session 5. The change from baseline for Topiramate is the value at 2.5 hours post-dose at the Topiramate visit minus the value
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 |
What the finished NCT01889602 record still lists
NCT01889602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01889602 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01889602's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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