AzTrials
AzTrials

EpilepsyPhase 3NCT01128959

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

A Phase 3 study testing Intravenous Carbamazepine (IV CBZ) in people with Epilepsy, run by Lundbeck LLC at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Epilepsy
What is being tested?
Intravenous Carbamazepine (IV CBZ)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
29 sitesUnited States
Study dates
Jun 2010to Jan 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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)
  • 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.

Who cannot join

  • 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.
Show all 25Show fewer
  • 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.
  • The patient has previously been administered IV CBZ in a previous clinical trial (for example OV-1015).
  • 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.
  • The patient has had a diagnosis of drug or alcohol abuse within the past year prior to Screening.
  • The patient has had significant blood loss (>500 mL) or donation within 14 days of Screening.
  • The patient has a history of poor oral CBZ compliance.
  • The patient is participating in a weight loss or nicotine cessation program.
  • The patient has a history of increased intraocular pressure or is on medication for glaucoma.
  • 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).
  • The patient has previously participated in this study.
  • The patient is a member of the site personnel or their immediate families.

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20815

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Virginia

    Charlottesville, Virginia, 22903

  • The Comprehensive Epilepsy Care Center for Children and Adults

    Chesterfield, Missouri, 63017

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Neurological Clinic of Texas, P.A.

    Dallas, Texas, 75230

  • Denver Health and Hospital Authority

    Denver, Colorado, 80204

  • Leonard J. Chabert Medical Center

    Houma, Louisiana, 70363

  • Clinical Trials Incorporated

    Little Rock, Arkansas, 72205

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70115

  • Langone Medical Center NYU Comprehensive Epilepsy Center

    New York, New York, 10016

  • Columbia University Medical Center: Dept of Neurology

    New York, New York, 10032

  • Temple University Health systems

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • VCU Medical Center

    Richmond, Virginia, 23298-0599

  • University of Rochester

    Rochester, New York, 14642

  • University of Minnesota & Prism Research

    Saint Paul, Minnesota, 55114

  • Southern illinois University School of Medicine

    Springfield, Illinois, 62702

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33606

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Montefiore Medicical Center

    The Bronx, New York, 10467

  • Collaborative Neuroscience Network, Inc.

    Torrance, California, 90502

  • Via Christi Epilepsy Center

    Wichita, Kansas, 67214

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the detailed description

This was 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 included a 28 day Lead-in Period, a Confinement Period (up to 7 days and 6 nights) and a 28 day Follow-up Period.

Patients began 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 began the 24hr urine collection for evaluation of urinary biomarkers. All patients temporarily discontinued 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.

Conditions
Epilepsy
Being tested
Intravenous Carbamazepine (IV CBZ)
Keywords
Epilepsy, Intravenous Carbamazepine, Oral Carbamazepine
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01128959
Study groupRoleWhat they receive
Intravenous Carbamazepine (IV CBZ)ExperimentalNot described
Receives: Drug: Intravenous Carbamazepine (IV CBZ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Measured: Baseline to after last iv dose on day 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionJan 2013
  4. Study completionJan 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01128959
Sponsor's protocol ID
13181A
Status last verified
Dec 2017
First submitted
21 May 2010
Last updated
16 Jan 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 25912051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravenous Carbamazepine (IV CBZ) in people with Epilepsy, run by Lundbeck LLC at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Baseline to after last iv dose on day 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01128959, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in