Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Approximately 50 subjects at multiple sites will crossover to receive both treatments (lacosamide [LCM]and carbamazepine immediate release [CBZ-IR]) in a randomized order during the 2 study treatment periods (Treatment Period 1 and Treatment Period 2).
A Screening Visit will be conducted to evaluate subject eligibility for enrollment into the study. Eligible subjects will return up to 21 days after the Screening Visit and begin Treatment Period 1. During Visit 2, eligible subjects will be randomized to receive either LCM 300 mg/day or CBZ-IR 600 mg/day. Subjects will be treated with their first randomized Antiepileptic Drug (AED) for 6 weeks (Titration Period [21 days] and Maintenance Period [21 days]). Subjects then complete a 28-day Taper/Washout Period, during which their first AED will be tapered over 4 days followed by a 24-day Washout Period, where subjects will receive no AED. Upon completion of the Taper/Washout Period, subjects will begin Treatment Period 2.The procedures and assessments for Treatment Period 1 will be repeated for Treatment Period 2 (with the same duration of treatment).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCM 300 mg/CBZ-IR 600 mg | Other | Crossover sequence of experimental treatment and active comparator |
|
| CBZ-IR 600 mg/LCM 300 mg | Other | Crossover sequence of active comparator and experimental treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide (LCM) | Drug | LCM 300 mg: LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules. Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases. Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Within-subject Difference In The Overall Neuropsychological Composite Score During Both Treatment Periods | 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). | From 6-week Treatment Period 1 to 6-week Treatment Period 2 (Visit 1- Visit 9) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | 877-822-9493 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 001 | Atlanta | Georgia | United States | |||
| 002 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27517350 | Derived | Meador KJ, Loring DW, Boyd A, Echauz J, LaRoche S, Velez-Ruiz N, Korb P, Byrnes W, Dilley D, Borghs S, De Backer M, Story T, Dedeken P, Webster E. Randomized double-blind comparison of cognitive and EEG effects of lacosamide and carbamazepine. Epilepsy Behav. 2016 Sep;62:267-75. doi: 10.1016/j.yebeh.2016.07.007. Epub 2016 Aug 10. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Carbamazepine Immediate Release (CBZ-IR) | Drug | CBZ-IR 600 mg: CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill. LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases. Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period. |
|
|
| Overland Park |
| Kansas |
| United States |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |