Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
Information source: Lundbeck Inc.
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Epilepsy
Intervention: Intravenous Carbamazepine (IV CBZ) (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Lundbeck Inc. Official(s) and/or principal investigator(s):
Email contact via H. Lundbeck A/S, Study Director, Affiliation: LundbeckClinicalTrials@lundbeck.com
Overall contact:
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com
Summary
The purpose of this study is to assess the safety and tolerability of intravenous (IV)
carbamazepine (CBZ) administered as multiple 15 minute infusions to adult patients with
epilepsy on stable higher doses of oral CBZ.
Clinical Details
Official title: Open-Label Study to Assess the Safety and Tolerability of Intravenous Carbamazepine as Short-Term Replacement of Oral Carbamazepine in Adult Patients With Epilepsy
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The primary objective to assess the safety and tolerability of IV CBZ administered as multiple 15 minute infusions to adult patients with epilepsy on stable higher doses of oral CBZ includes adverse events, laboratory test results, and ECG parameters
Secondary outcome: For the secondary objective to assess biomarkers for renal effect of IV CBZ, the variables of interest include the analytes collected in the 24-hour urine collection relative to the creatinine volume excreted
Detailed description:
This is a phase III, multicenter, open-label study designed to assess the safety and
tolerability of intravenously administered CBZ in adult patients with epilepsy. This study
will include a 28 day Lead-in Period, a Confinement Period (up to 7 days and 6 nights) and a
28 day Follow-up Period.
Patients will begin confinement on Day - 1 of the trial, continuing to take their oral CBZ as
prescribed by the investigator. On the morning of Day 0, Day 4, and Day 17, patients will
begin the 24hr urine collection for evaluation of urinary biomarkers. All patients will
temporarily discontinue their prescribed oral CBZ and begin IV CBZ administration on the
morning of Day 1, continuing administrations every 6 hours (Q6h) through the morning of Day
4.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. The patient is a man or a non-pregnant woman who is at least 18 years of age.
3. 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.
4. 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
- Mixed seizure patterns that include the above, or other partial or generalised seizures (except absence seizures - please see exclusion point number 12)
5. 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.
6. 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.
7. The patient is not expected to have any change in his/her baseline AED treatment
during the treatment period.
8. The patient is able to comply with maintaining an accurate Seizure and antiepileptic
drug diary.
9. 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.
Exclusion Criteria:
1. 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.
2. The patient has a history of previous bone marrow depression.
3. The patient has a history of intolerance to IV administration of medication.
4. The patient is pregnant or lactating.
5. The patient is being treated with a monoamine oxidase (MAO) inhibitor.
6. The patient is using oral, intramuscular, or any other hormone delivery method as
their primary form of birth control.
7. The patient has an ECG with corrected QT interval by Fridericia's correction formula
(QTcF) greater than 450 msec at Screening or Day - 1.
8. The patient has a screening ALT, AST or bilirubin >=3 times the upper limit of
normal.
9. The patient has an estimated ClCR (based of Cockcroft-Gault) of <50 ml/min.
10. The patient has had a clinically significant illness/infection or has had any
surgical procedure within 30 days prior to Screening.
11. 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.
12. The patient is receiving oral CBZ for absence seizures.
13. The patient has had an episode of status epilepticus within 4 weeks of Screening.
14. The patient has a history of severe or serious adverse reactions to CBZ (for example,
aplastic anemia, agranulocytosis, SJS.
15. The patient has taken or used any investigational drug or device in the 30 days prior
to Screening.
16. The patient has previously been administered IV CBZ in a previous clinical trial (for
example OV-1015).
17. The patient has a urine toxicology screen positive for phencyclidine, benzodiazepines
(unless due to the patient's concomitant AEDs), cannabinoids, cocaine, amphetamines,
opiates, barbiturates (unless due to the patient's concomitant AEDs), or alcohol at
Screening or Day - 1.
18. The patient has had a diagnosis of drug or alcohol abuse within the past year prior
to Screening.
19. The patient has had significant blood loss (>500 mL) or donation within 14 days of
Screening.
20. The patient has a history of poor oral CBZ compliance.
21. The patient is participating in a weight loss or nicotine cessation program.
22. The patient has a history of increased intraocular pressure or is on medication for
glaucoma.
23. The patient is considered by the investigator to be an unsuitable candidate for the
study, which may include an increase in the frequency, severity and duration of
seizures during the Pre-Treatment Period (Days - 28-0).
24. The patient has previously participated in this study.
25. The patient is a member of the site personnel or their immediate families.
Locations and Contacts
Email contact via H. Lundbeck A/S, Email: LundbeckClinicalTrials@lundbeck.com
Mayo Clinic Arizona, Phoenix, Arizona 85054, United States; Terminated
Clinical Trials Incorporated, Little Rock, Arkansas 72205, United States; Recruiting
Victor Biton, Phone: 501-227-6179
Collaborative Neuroscience Network, Inc., Torrance, California 90502, United States; Recruiting
Omid Omidvar, Phone: 310-523-4200
Denver Health and Hospital Authority, Denver, Colorado 80204, United States; Recruiting
Edward Maa, Phone: 303-436-6822
Central DuPage Hospital, Winfield, Illinois 60190, United States; Recruiting
Roy Sucholeiki, Phone: 630-933-4056
Via Christi Epilepsy Center, Wichita, Kansas 67214, United States; Recruiting
Bassem El-Nabbout, Phone: 316-268-8500
Leonard J. Chabert Medical Center, Houma, Louisiana 70363, United States; Recruiting
Michael Charlet, Phone: 985-873-5143
Louisiana Research Associates, New Orleans, Louisiana 70114, United States; Terminated
Ochsner Clinic Foundation, New Orleans, Louisiana 70115, United States; Recruiting
R. Eugene Ramsay, Phone: 504-842-3977
Mid-Atlantic Epilepsy and Sleep Center, Bethesda, Maryland 20815, United States; Recruiting
Pavel Klein, Phone: 301-530-9744
Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Susan Herman, Phone: 617-632-8934
University of Minnesota & Prism Research, St. Paul, Minnesota 55114, United States; Recruiting
Ilo Leppik, Phone: 612-625-7139
The Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield, Missouri 63017, United States; Recruiting
William Rosenfeld, Phone: 314-453-9300
Montefiore Medicical Center, Bronx, New York 10467, United States; Recruiting
Alex Boro, Phone: 718-920-2898
Langone Medical Center NYU Comprehensive Epilepsy Center, New York, New York 10016, United States; Recruiting
Jackie French, Phone: 646-558-0842
University of Rochester, Rochester, New York 14642, United States; Recruiting
J. Craig Henry, Phone: 585-275-0404
SUNY Upstate Medical University, Syracuse, New York 13210, United States; Recruiting
Robert Beach, Phone: 315-464-4998
Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Nancy Foldvary-Schaefer, Phone: 216-445-2990
Temple University Health systems, Philadelphia, Pennsylvania 19140, United States; Recruiting
Mercedes Jacobson, Phone: 215-707-1943
Medical University of South Carolina, Charleston, South Carolina 29425, United States; Recruiting
Jonathan Halford, Phone: 843-792-5044
Neurological Clinic of Texas, P.A., Dallas, Texas 75230, United States; Recruiting
Robert F Leroy, M.D., Phone: 972-566-7690
Scott & White Memorial Hospital, Temple, Texas 76508, United States; Recruiting
Bartool F Kirmani, Phone: 254-724-7727
VCU Medical Center, Richmond, Virginia 23298-0599, United States; Recruiting
Elizabeth Waterhouse, Phone: 804-828-9583
Additional Information
Starting date: June 2010
Last updated: September 20, 2011
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