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

NCT01128959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2018-01-16

Study results available
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Summary

The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute infusion to adult patients with epilepsy on stable higher doses of oral CBZ.

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Ligand Pharmaceuticals

    collaborator INDUSTRY

  • ICON Clinical Research

    collaborator INDUSTRY

  • Quintiles, Inc.

    collaborator INDUSTRY

  • Lundbeck LLC

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128959 on ClinicalTrials.gov