Trial Outcomes & Findings for Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy (NCT NCT01128959)

Last Updated: 2018-01-16

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

Baseline to after last iv dose on day 4

Results posted on

2018-01-16

The patients were recruited through physician referrals and/or recruitment methods at hospitals and clinics. Advertisements were used by 5 sites.

Participant milestones
Measure	Intravenous Carbamazepine (IV CBZ) Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
Lead in Period STARTED	108
Lead in Period COMPLETED	105
Lead in Period NOT COMPLETED	3
Treatment Period STARTED	105
Treatment Period COMPLETED	101
Treatment Period NOT COMPLETED	4

Reasons for withdrawal
Measure	Intravenous Carbamazepine (IV CBZ) Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
Lead in Period Adverse Event	3
Treatment Period Adverse Event	3
Treatment Period Withdrawal by Subject	1

Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy

Baseline characteristics by cohort
Measure	Intravenous Carbamazepine (IV CBZ) n=105 Participants Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
Age, Continuous	40.7 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	22 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	86 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

Timeframe: Baseline to after last iv dose on day 4

Population: All Patients Treated Set

Outcome measures
Measure	Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion n=105 Participants Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.	Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion n=101 Participants Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
Adverse Events	126 Number of adverse events	26 Number of adverse events

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events
Measure	Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion n=105 participants at risk	Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion n=101 participants at risk
Nervous system disorders Cerebral Haemorrhage	0.95% 1/105 • Number of events 1 • Baseline to to after last iv dose on day 4	0.00% 0/101 • Baseline to to after last iv dose on day 4
Nervous system disorders Convulsion	0.95% 1/105 • Number of events 1 • Baseline to to after last iv dose on day 4	0.00% 0/101 • Baseline to to after last iv dose on day 4

Other adverse events
Measure	Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion n=105 participants at risk	Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion n=101 participants at risk
Nervous system disorders Dizziness	19.0% 20/105 • Baseline to to after last iv dose on day 4	10.9% 11/101 • Baseline to to after last iv dose on day 4
Nervous system disorders Headache	8.6% 9/105 • Baseline to to after last iv dose on day 4	0.00% 0/101 • Baseline to to after last iv dose on day 4
Nervous system disorders Somnolence	6.7% 7/105 • Baseline to to after last iv dose on day 4	0.99% 1/101 • Baseline to to after last iv dose on day 4

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