Trial Outcomes & Findings for Levetiracetam in Early Psychosis (NCT NCT03129360)
NCT ID: NCT03129360
Last Updated: 2022-11-21
Results Overview
CBF will be measured by Arterial Spin Labeling (ASL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Baseline, 2 Hours Post-Treatment
Results posted on
2022-11-21
Participant Flow
Participant milestones
| Measure |
Levetiracetam 185 mg
A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Levetiracetam 500mg
A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Placebo
A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Placebo: Prepared in capsules to appear identical to levetiracetam.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Levetiracetam 185 mg
A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Levetiracetam 500mg
A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Placebo
A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Placebo: Prepared in capsules to appear identical to levetiracetam.
|
|---|---|---|---|
|
Overall Study
Did not meet entry criteria
|
0
|
2
|
1
|
|
Overall Study
Excluded due to motion in scanner
|
1
|
0
|
0
|
Baseline Characteristics
Levetiracetam in Early Psychosis
Baseline characteristics by cohort
| Measure |
Levetiracetam 185 mg
n=8 Participants
A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Levetiracetam 500mg
n=6 Participants
A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Placebo
n=7 Participants
A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Placebo: Prepared in capsules to appear identical to levetiracetam.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.13 years
STANDARD_DEVIATION 5.94 • n=5 Participants
|
25.17 years
STANDARD_DEVIATION 4.07 • n=7 Participants
|
25.17 years
STANDARD_DEVIATION 2.35 • n=5 Participants
|
25.16 years
STANDARD_DEVIATION 4.49 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 Hours Post-TreatmentCBF will be measured by Arterial Spin Labeling (ASL)
Outcome measures
| Measure |
Levetiracetam 185 mg
n=8 Participants
A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Levetiracetam 500mg
n=6 Participants
A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Placebo
n=7 Participants
A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Placebo: Prepared in capsules to appear identical to levetiracetam.
|
|---|---|---|---|
|
Change in Cerebral Blood Flow (CBF)
|
-2.21 mL / (100g * min)
Standard Deviation 3.2
|
-3.83 mL / (100g * min)
Standard Deviation 2.29
|
-1.29 mL / (100g * min)
Standard Deviation 1.66
|
Adverse Events
Levetiracetam 185 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Levetiracetam 500mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levetiracetam 185 mg
n=9 participants at risk
A single dose of 185mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Levetiracetam 500mg
n=8 participants at risk
A single dose of 500mg of levetiracetam administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Levetiracetam: Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
|
Placebo
n=8 participants at risk
A single dose of placebo administered orally to participants. Participants undergo a 15-minute MRI scan using arterial spin labeling (ASL) before dosing and two hours post-dosing.
Placebo: Prepared in capsules to appear identical to levetiracetam.
|
|---|---|---|---|
|
Nervous system disorders
Memory Problems
|
0.00%
0/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
12.5%
1/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
|
Nervous system disorders
Sedation/Drowsiness
|
11.1%
1/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
12.5%
1/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
|
Nervous system disorders
Hallucinations
|
0.00%
0/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
12.5%
1/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
|
General disorders
Dizziness
|
0.00%
0/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
12.5%
1/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
|
Nervous system disorders
Yelling/anger
|
0.00%
0/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
12.5%
1/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
|
General disorders
Night sweats/vivid dreams/overheated feeling
|
11.1%
1/9 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
0.00%
0/8 • 3 Years
Systematic assessment via administration of the Systematic Assessment for Treatment Emergent Side Effects (SAFTEE) questionnaire and follow-up phone call monitoring.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place