Trial Outcomes & Findings for Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients (NCT NCT00223262)
NCT ID: NCT00223262
Last Updated: 2019-04-16
Results Overview
Rey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.
COMPLETED
PHASE4
28 participants
24 weeks
2019-04-16
Participant Flow
Participant milestones
| Measure |
Lamotrigine
Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
|
Placebo
Matched placebo identical in appearance to the active drug.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
12
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of Lamotrigine to Reverse Cognitive Impairment in Chronic Corticosteroid-Treated Patients
Baseline characteristics by cohort
| Measure |
Lamotrigine
n=8 Participants
Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
|
Placebo
n=11 Participants
Matched placebo identical in appearance to the active drug.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
47.4 years
STANDARD_DEVIATION 13.3 • n=107 Participants
|
46.0 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
11 participants
n=107 Participants
|
19 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 weeksRey Auditory Verbal Learning Test (RAVLT) is a test of verbal learning and declarative memory. During the test, 15 nouns that are read aloud for 5 consecutive trials. Each trial is followed by a free recall test (participant is asked to recall the words that were just read to them). The sum of correctly recalled words across 5 trials is called the total raw score. On completion of Trial 5, an interference list of 15 words (List B) is presented, followed by a free recall test of that list. After a 20-min delay, the examinee is again required to recall the words from list A - this is called the delay raw score. The raw scores on both the total recall and the delay trials (number of words correct across trials 1-5) are converted to standardized T-scores (Mean=50; SD=10; range 20-100) based on participant age and gender. The scores below are presented as T-scores, with higher scores indicative of better performance.
Outcome measures
| Measure |
Lamotrigine
n=8 Participants
Lamotrigine was initiated at 25 mg/day for 2 weeks, increased to 50 mg/day for 2 weeks, and then increased in 50 mg/day increments weekly to a dose of 400 mg/day at week 10 using a fixed dosing schedule.
|
Placebo
n=11 Participants
Matched placebo identical in appearance to the active drug.
|
|---|---|---|
|
Rey Auditory Verbal Learning Test (RAVLT)
|
46.1 T-scores
Standard Deviation 15.0
|
40.1 T-scores
Standard Deviation 11.0
|
Adverse Events
Lamotrigine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
E. Sherwood Brown, MD, PhD
University of Texas Southwestern Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place