Clinical trial NCT02912364: Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Official title: Double-Blind, Randomized, Two Period Crossover Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Keywords: Eslicarbazepine
Carbamazepine
cognition
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Sumitomo Pharma America, Inc.
First posted: 2016-09-23
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Double-blind, randomized, two period crossover comparison of the cognitive and behavioral effects of Eslicarbazepine acetate and Carbamazepine in healthy volunteers.

Detailed description: This study is a double-blind, randomized, two period crossover design. The study consists of 6 visits over a 21 week period. Forty six (46) normal healthy subjects will be treated with both Eslicarbazepine acetate (ESL, 800 mg/day) and Carbamazepine (CBZ, 800mg/day) for 6 weeks and 3 days each (maintenance 4 weeks and taper 3 days). Each antiepileptic drug (AED) treatment period will be followed by a four day taper and washout period off AED for the remainder of the month. Cognitive and behavioral testing along with safety testing will be conducted at pretreatment baseline, the end of each randomization AED maintenance period, and after the final washout period.

Eligibility criteria: Inclusion Criteria:

1. Healthy adults between the ages of 18 and 55 years old.
2. Male or female

Exclusion Criteria:

1. Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
2. Presence or history of drug or alcohol abuse.
3. The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
4. Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
5. Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
6. Prior participation in studies involving anticonvulsant medications.
7. Subjects who have received any investigational drug within the previous thirty days.
8. Subjects with IQ \< 70 as determined by the Peabody Picture Vocabulary Test.
9. Presence of HLA B\*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.

Primary outcomes:
measure: Overall Composite Z Score of Neuropsychological Battery as a Measure of Direct Comparison of the 2 Antiepileptic Drugs.
timeFrame: At the end of each 6-week drug treatment period.
Secondary outcomes:
measure: Overall Z-score for Executive Function.
timeFrame: At the end of each 6-week drug treatment period.
measure: MCG Paragraph Recall Scores.
timeFrame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
measure: Dual Task Percent of Time in Box.
timeFrame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
measure: Profile of Mood States (POMS) Score.
timeFrame: Prior to treatment (non-drug condition average) and at the end of each six-week treatment period.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Kimford Meador, MD
role: PRINCIPAL_INVESTIGATOR
References: