Trial record 1 of 1 for:    BTTC 11-01
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Lacosamide for Seizure Prophylaxis in High-Grade Gliomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborators:
Brain Tumor Trials Collaborative
UCB Pharma
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01432171
First received: September 8, 2011
Last updated: May 15, 2014
Last verified: May 2014

September 8, 2011
May 15, 2014
July 2012
July 2018   (final data collection date for primary outcome measure)
Time to First Seizure (TFS) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
The primary measure of efficacy is time to first seizure (TFS). The primary test of the difference in TFS between the treatment arms based on the likelihood ratio statistic for the treatment effect in a stratified proportional hazards regression model with anticonvulsant use as the stratification factor. The conditional power for the time-to-event outcome computed based on the method described in Design and Analysis of Clinical Trials with Time-to-Event Endpoints and Lan Simon and Halperin.
Time to First Seizure (TFS) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
The primary measure of efficacy is time to first seizure (TFS). The primary test of the difference in TFS between the treatment arms will be based on the likelihood ratio statistic for the treatment effect in a stratified proportional hazards regression model with anticonvulsant use as the stratification factor. The conditional power for the time-to-event outcome will be computed based on the method described in Design and Analysis of Clinical Trials with Time-to-Event Endpoints and Lan Simon and Halperin.
Complete list of historical versions of study NCT01432171 on ClinicalTrials.gov Archive Site
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Lacosamide for Seizure Prophylaxis in High-Grade Gliomas
Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas

The goal of this clinical research study is to learn if an antiepileptic (anti-seizure) treatment will prevent seizures in patients with brain tumors who have not yet had a seizure. Anti-seizure drugs are designed to decrease abnormal electrical activity in the brain that plays a role in developing seizures.

In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be compared to a placebo.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to receive either lacosamide or a placebo. Neither you nor your doctor will know if you are receiving the study drug or placebo. However, if needed for your safety during the study, the study staff and study doctor will be able to find out what you are receiving.

You will take lacosamide or placebo by mouth 2 times a day, at about the same times each day, spaced as close to 12 hours apart as possible. The study drug/placebo may be taken with or without food. Missed doses should be only taken within 6 hours of the scheduled time.

If you vomit while taking the study drug/placebo, you should not take more pills before the next scheduled dose unless the pill can be clearly identified in the vomit.

You will be given a drug diary to fill out each day that you take the study pills. The study staff will explain how to fill out this diary.

Study Visits:

Every month:

-You will be called and asked questions about any side effects you may be having. and about your mood.

At Months 1, 4, 7, and 10:

  • Your medical history will be recorded, including any drugs you may have taken and/or may be taking.
  • You will have a physical exam, including measurement of your vital signs.
  • Your performance status will be recorded.
  • You will have a neurological exam.
  • At Months 4, 7, and 10, you will be asked about any side effects you may be having.

At any time during the study, extra tests may be performed if the doctor thinks they are needed for your safety. The study doctor will tell you more about any extra tests.

Length of Study:

You may take lacosamide or placebo for up to 1 year. Your study doctor may take you off the study early if he or she feels it is not in your best interest, you have new health problems that make taking part in the study possibly dangerous, if intolerable side effects occur, or if you are unable to follow study directions.

You will be considered off-study once you complete the Long-Term Follow-Up.

End-of-Dosing Visit:

After you stopped taking the study drug/placebo, you will have an end-of-dosing visit. At this visit, the following tests and procedures will be performed:

  • Your medical history will be recorded, including any drugs you may have taken and/or may be taking and any side effects you may be having.
  • You will complete the questionnaire about your mood.
  • You will have a physical exam, including measurement of your vital signs.
  • Your performance status will be recorded.
  • You will have a neurological exam.

Long-Term Follow-Up:

Every 3 months after your End-of-Study visit, for about 5 years, you may be called and asked how you are feeling if you do not schedule a required monthly follow up visit. This phone call will take about 5-10 minutes.

This is an investigational study. Lacosamide is FDA approved and commercially available for the treatment of seizures. Its use to reduce the risk of seizures in patients with malignant gliomas is investigational.

Up to 302 patients will take part in this multicenter study. Up to 60 will be enrolled at MD Anderson.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Brain Cancer
  • Drug: Lacosamide
    Starting dose: 50 mg by mouth twice a day.
    Other Name: Vimpat
  • Other: Placebo
    To be taken by mouth twice daily.
    Other Name: sugar pill
  • Experimental: Lacosamide
    Lacosamide or placebo will be taken by mouth twice a day, at approximately the same time each day, spaced as close to 12 hours apart as possible. The starting dose of lacosamide or placebo will be 50 mg PO bid. Over 4 weeks, the dose should be increased to a target dose of 200 mg bid. A recommended scheme for dose escalation is to increase by 100 mg/day weekly until 200 mg bid is achieved.
    Intervention: Drug: Lacosamide
  • Placebo Comparator: Placebo
    Lacosamide or placebo will be taken by mouth twice a day, at approximately the same time each day, spaced as close to 12 hours apart as possible. The starting dose of lacosamide or placebo will be 50 mg PO bid. Over 4 weeks, the dose should be increased to a target dose of 200 mg bid. A recommended scheme for dose escalation is to increase by 100 mg/day weekly until 200 mg bid is achieved.
    Intervention: Other: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
302
Not Provided
July 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with histologically confirmed supratentorial high-grade glioma will be eligible for this protocol.
  2. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
  3. Patients must have signed an authorization for the release of their protected health information.
  4. Patients must be >/= 18 years old.
  5. Patients must have a Karnofsky performance status of >/= 60.
  6. Women of childbearing potential must have a negative beta-HCG pregnancy test documented within 2 weeks prior to registration.
  7. In the opinion of the treating investigator, patients must have adequate cognitive abilities to complete the neurocognitive components of the study.
  8. Patients must be able to safely swallow pills.
  9. Patients must agree to practice adequate contraception.
  10. Patients must be registered on study within 16 weeks after the surgical procedure that established the diagnosis of High Grade Glioma.

Exclusion Criteria:

  1. Patients must not have any significant medical or psychiatric illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
  2. Patients must not have serious intercurrent medical illness. Serious, active co-morbidity, defined as follows: a) Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months. b) Transmural myocardial infarction within the last 6 months. c) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. d) Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. e) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
  3. (2. continued) f) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. g) Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
  4. Patients must not be pregnant or breast feeding. Patients must not be pregnant because lacosamide produced developmental toxicity in rats following administration during pregnancy. There is insufficient information to determine if lacosamide is safe during lactation.
  5. Patients must not have any disease that will obscure toxicity or dangerously alter Drug metabolism
  6. Patients must not have a history of heart block or cardiac arrhythmia, including asymptomatic arrhythmias and atrial fibrillation/flutter.
  7. Patients must not have a prolonged PR interval (defined as > 200 ms).
  8. Perioperative anticonvulsants should be tapered as indicated in the protocol.
  9. Patients must not have a history of any type of seizure for at least 10 years prior to registration.
Both
18 Years and older
No
Contact: Mark R. Gilbert, MD,BS 713-792-2883
United States
 
NCT01432171
BTTC11-01, NCI-2011-03055
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
  • Brain Tumor Trials Collaborative
  • UCB Pharma
Principal Investigator: Mark R. Gilbert, MD,BS UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP