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

NCT01128959 | Completed Phase 3 Results

• 1 other identifier: 13181A
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 29

Brief 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

Epilepsy

Keywords

Epilepsy; Intravenous Carbamazepine; Oral Carbamazepine

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Baseline to after last iv dose on day 4

Study Arms (1)

Intravenous Carbamazepine (IV CBZ)

EXPERIMENTAL

Drug: Intravenous Carbamazepine (IV CBZ)

Interventions

Intravenous Carbamazepine (IV CBZ) DRUG

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient or legal representative must be able to read, understand, sign and date the IRB approved Informed Consent Form and HIPAA Authorization prior to study participation.
• The patient is a man or a non-pregnant woman who is at least 18 years of age.
• If a woman:
• Patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomay or hysterectomy), or if childbearing potential, must comply with a method of birth control acceptable to the investigator during the study, for at least 28 days prior to Day 1 and for 28 days following completion of the study.
• Patient is not breastfeeding.
• Patient of childbearing potential must have a negative serum pregnancy test at Day -28 and a negative urine pregnancy test or serum pregnancy test at Day -1.
• The patient is diagnosed with any of the approved epilepsy indications for CBZ:
• Partial seizures with complex symptomatology (psychomotor, temporal lobe)
• Generalised tonic clonic seizures (GTCS) (grand mal): myoclonic, clonic, tonic, tonic-clonic, atonic
• The patient is receiving a stable dose of oral CBZ (tablet or capsule formulation) of 1200 mg/day to 2000 mg/day, for a minimum of 14 days prior to Day -28.
• The patient is receiving a constant dose of all other concomitant medications used for chronic conditions, (including OTC medications and herbal supplements) for a minimum of 28 days prior to Day 1.
• The patient is not expected to have any change in his/her baseline AED treatment during the treatment period.
• The patient is able to comply with maintaining an accurate Seizure and antiepileptic drug diary.
• The patient is able to comply with all study procedures including complying with protocol determined dosing intervals, confinement at the investigative site for up to 6 nights and 7 days, and agrees to participate in the entire study.

You may not qualify if:

• The patient has a known hypersensitivity to CBZ, Captisol, or to any of the tricyclic compounds, such as amitriptyline, trimipramine, imipramine; oxacarbazepine, phenytoin, or their analogues or metabolites.
• The patient has a history of previous bone marrow depression.
• The patient has a history of intolerance to IV administration of medication.
• The patient is pregnant or lactating.
• The patient is being treated with a monoamine oxidase (MAO) inhibitor.
• The patient is using oral, intramuscular, or any other hormone delivery method as their primary form of birth control.
• The patient has an ECG with corrected QT interval by Fridericia's correction formula (QTcF) greater than 450 msec at Screening or Day -1.
• The patient has a screening ALT, AST or bilirubin \>=3 times the upper limit of normal.
• The patient has an estimated ClCR (based of Cockcroft-Gault) of \<50 ml/min.
• The patient has had a clinically significant illness/infection or has had any surgical procedure within 30 days prior to Screening.
• The patient has a significant history of cardiac, renal, neurologic (other than epilepsy), psychiatric, oncologic, endocrinologic, metabolic, or hepatic disease, which would adversely affect their participation in this study.
• The patient is receiving oral CBZ for absence seizures.
• The patient has had an episode of status epilepticus within 4 weeks of Screening.
• The patient has a history of severe or serious adverse reactions to CBZ (for example, aplastic anemia, agranulocytosis, SJS.
• The patient has taken or used any investigational drug or device in the 30 days prior to Screening.

Sponsors & Collaborators

• Lundbeck LLC: lead
• Ligand Pharmaceuticals: collaborator
• ICON Clinical Research: collaborator
• Quintiles, Inc.: collaborator

Study Sites (29)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Clinical Trials Incorporated

Little Rock, Arkansas, 72205, United States

Location

Collaborative Neuroscience Network, Inc.

Torrance, California, 90502, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Southern illinois University School of Medicine

Springfield, Illinois, 62702, United States

Location

Central DuPage Hospital

Winfield, Illinois, 60190, United States

Location

Via Christi Epilepsy Center

Wichita, Kansas, 67214, United States

Location

Leonard J. Chabert Medical Center

Houma, Louisiana, 70363, United States

Location

Louisiana Research Associates

New Orleans, Louisiana, 70114, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20815, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Minnesota & Prism Research

Saint Paul, Minnesota, 55114, United States

Location

The Comprehensive Epilepsy Care Center for Children and Adults

Chesterfield, Missouri, 63017, United States

Location

Langone Medical Center NYU Comprehensive Epilepsy Center

New York, New York, 10016, United States

Location

Columbia University Medical Center: Dept of Neurology

New York, New York, 10032, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medicical Center

The Bronx, New York, 10467, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Temple University Health systems

Philadelphia, Pennsylvania, 19140, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Neurological Clinic of Texas, P.A.

Dallas, Texas, 75230, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

VCU Medical Center

Richmond, Virginia, 23298-0599, United States

Location

Related Publications (1)

• Lee D, Kalu U, Halford JJ, Biton V, Cloyd J, Klein P, Bekersky I, Peng G, Dheerendra S, Tolbert D. Intravenous carbamazepine as short-term replacement therapy for oral carbamazepine in adults with epilepsy: Pooled tolerability results from two open-label trials. Epilepsia. 2015 Jun;56(6):906-14. doi: 10.1111/epi.12991. Epub 2015 Apr 25.

  PMID: 25912051 DERIVED

MeSH Terms

Conditions

Epilepsy

Interventions

Carbamazepine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Lundbeck LLC
• Organization: Lundbeck LCC

LundbeckClinicalTrials@lundbeck.com

+45 36301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 16, 2018
• Results First Posted: December 5, 2016

Record last verified: 2017-12

Locations

US (29)