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Trial record 20 of 23 for:    betadex

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

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ClinicalTrials.gov Identifier: NCT01128959
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : December 5, 2016
Last Update Posted : January 16, 2018
Sponsor:
Collaborators:
Ligand Pharmaceuticals
ICON Clinical Research
Quintiles, Inc.
Information provided by (Responsible Party):
Lundbeck LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Intravenous Carbamazepine (IV CBZ)
Enrollment 108
Recruitment Details The patients were recruited through physician referrals and/or recruitment methods at hospitals and clinics. Advertisements were used by 5 sites.
Pre-assignment Details  
Arm/Group Title Intravenous Carbamazepine (IV CBZ)
Hide Arm/Group Description 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.
Period Title: Lead in Period
Started 108
Completed 105
Not Completed 3
Reason Not Completed
Adverse Event             3
Period Title: Treatment Period
Started 105
Completed 101
Not Completed 4
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             1
Arm/Group Title Intravenous Carbamazepine (IV CBZ)
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants
40.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Female
52
  49.5%
Male
53
  50.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
American Indian or Alaska Native
1
   1.0%
Asian
2
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
22
  21.0%
White
72
  68.6%
More than one race
0
   0.0%
Unknown or Not Reported
8
   7.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants
Hispanic or Latino
19
  18.1%
Not Hispanic or Latino
86
  81.9%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Adverse Events
Hide Description [Not Specified]
Time Frame Baseline to after last iv dose on day 4
Hide Outcome Measure Data
Hide Analysis Population Description
All Patients Treated Set
Arm/Group Title Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion
Hide Arm/Group Description:
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): 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.
Overall Number of Participants Analyzed 105 101
Measure Type: Number
Unit of Measure: Number of adverse events
126 26
Time Frame Baseline to to after last iv dose on day 4
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/105 (1.90%)      0/101 (0.00%)    
Nervous system disorders     
Cerebral Haemorrhage * 1  1/105 (0.95%)  1 0/101 (0.00%)  0
Convulsion * 1  1/105 (0.95%)  1 0/101 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/105 (27.62%)      11/101 (10.89%)    
Nervous system disorders     
Dizziness * 1  20/105 (19.05%)  11/101 (10.89%) 
Headache * 1  9/105 (8.57%)  0/101 (0.00%) 
Somnolence * 1  7/105 (6.67%)  1/101 (0.99%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lundbeck LLC
Organization: Lundbeck LCC
Phone: +45 36301311
EMail: LundbeckClinicalTrials@lundbeck.com
Layout table for additonal information
Responsible Party: Lundbeck LLC
ClinicalTrials.gov Identifier: NCT01128959     History of Changes
Other Study ID Numbers: 13181A
First Submitted: May 21, 2010
First Posted: May 24, 2010
Results First Submitted: October 10, 2016
Results First Posted: December 5, 2016
Last Update Posted: January 16, 2018