Trial Outcomes & Findings for Reversing Corticosteroid Induced Memory Impairment (NCT NCT01142310)

Last Updated: 2018-08-27

Results Overview

The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

48 weeks

Results posted on

2018-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Lamotrigine Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48.	Placebo Placebo was administered the same as the Lamotrigine dose titration described.
Overall Study STARTED	26	28
Overall Study COMPLETED	17	16
Overall Study NOT COMPLETED	9	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reversing Corticosteroid Induced Memory Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lamotrigine n=26 Participants Participants took Lamotrigine beginning at 25mg/day and increased to a dose of 400mg/day over 10 weeks using a fixed scheduled.	Placebo n=28 Participants Placebo administered the same as the Lamotrigine.	Total n=54 Participants Total of all reporting groups
Age, Continuous	42.192 years STANDARD_DEVIATION 11.771 • n=5 Participants	46.286 years STANDARD_DEVIATION 9.974 • n=7 Participants	44.315 years STANDARD_DEVIATION 10.968 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	14 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Outcome measures

Outcome measures
Measure	Lamotrigine n=26 Participants Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48.	Placebo n=28 Participants Placebo was administered the same as the Lamotrigine dose titration described.
The Rey Auditory Verbal Learning Test (RAVLT)	45.741 T Score Standard Deviation 9.63	43.286 T Score Standard Deviation 6.57

Adverse Events

Lamotrigine

Serious events: 5 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Lamotrigine n=26 participants at risk Participants took Lamotrigine beginning at 25mg PO QD and increased to a dose of 400mg PO QD over 10 weeks using a fixed scheduled.	Placebo n=28 participants at risk Placebo was administered the same as Lamotrigine.
General disorders Cancer	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Surgical and medical procedures Foot Amputation	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Infections and infestations Kidney Stone	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Cardiac disorders Atrial Fibrillation	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Blood and lymphatic system disorders Thrombosis	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Infections and infestations Urinary Tract Infection	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Reproductive system and breast disorders Vaginal Bleeding	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Vascular disorders Hypotension	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Infections and infestations Bacterial Vaginosis	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Gastrointestinal disorders Gastroenteritis	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Infections and infestations Pneumonia	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Endocrine disorders Hyperglycemia	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Infections and infestations Influenza	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Surgical and medical procedures Kidney Biopsy	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.

Other adverse events

Other adverse events
Measure	Lamotrigine n=26 participants at risk Participants took Lamotrigine beginning at 25mg PO QD and increased to a dose of 400mg PO QD over 10 weeks using a fixed scheduled.	Placebo n=28 participants at risk Placebo was administered the same as Lamotrigine.
Social circumstances Fall	3.8% 1/26 • Number of events 2 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
General disorders Dizziness	7.7% 2/26 • Number of events 2 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Social circumstances Car Acciddent	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Respiratory, thoracic and mediastinal disorders Nose Bleed	0.00% 0/26 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	3.6% 1/28 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Eye disorders Keratoconus	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Vascular disorders Hypotension	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Vascular disorders Hypertension	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
Endocrine disorders Hypoglycemia	3.8% 1/26 • Number of events 1 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.	0.00% 0/28 • Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks. Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.

Additional Information

Dr. E. Sherwood Brown

UT Southwestern Medical Center

Phone: 214-645-6950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place