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NCT01530022 · ClinicalTrials.gov registry record · Phase 1
Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects
A Phase 1 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01530022: Completed Phase 1 study, sponsored by UCB Pharma.
NCT01530022 is a Phase 1 study that has completed, run by UCB Pharma. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01530022, a Phase 1 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.
Primary Outcome
The overall composite score will be computed as the sum of the individual cognitive test scores from computerized tests and non-computerized neuropsychological tests (including behavioral questionnaires) after transformation to a Z-scores to form an overall composite Z-score. The Z-score will be calculated using the values (mean and standard deviation) from the average of the scores from 3 non-drug conditions (Baseline, first Washout Period, and second Washout Period).
Interventions
- DRUG Lacosamide (LCM)
- DRUG Carbamazepine Immediate Release (CBZ-IR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01530022 record still lists
NCT01530022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Lacosamide (LCM) is the first listed.
NCT01530022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01530022 about?
NCT01530022 is a clinical study titled "Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects". The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR) after administration in healthy subjects. Safety, tolerability, and pharmacokinetic data will also be collected.
What is the current status of trial NCT01530022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2012-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01530022?
The interventions under investigation include: Lacosamide (LCM) (DRUG), Carbamazepine Immediate Release (CBZ-IR) (DRUG).
Who is sponsoring clinical trial NCT01530022?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01530022's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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