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Lacosamide in Preventing Seizures in Participants With Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01432171
Recruitment Status : Terminated
First Posted : September 12, 2011
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial studies how well lacosamide works in preventing seizures in participants with malignant glioma. Anti-seizure drugs, such as lacosamide, may decrease abnormal electrical activity in the brain that plays a role in developing seizures.

Condition or disease Intervention/treatment Phase
Malignant Glioma Drug: Lacosamide Other: Placebo Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine if prophylactic administration of Lacosamide reduces the risk of seizures in patients with high-grade glioma (HGG).

SECONDARY OBJECTIVES:

I. To determine the one-year risk of first seizure in this patient population. II. To evaluate patient reported symptoms.

EXPLORATORY OBJECTIVES:

I. To investigate clinical and electroencephalographic predictors of seizures in this patient population.

II. To evaluate the occurrence of symptoms and correlate to seizure activity as well as tolerance to treatment using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) self-reporting tool.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I (LACOSAMIDE): Participants receive lacosamide orally (PO) twice a day (BID) for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II (PLACEBO): Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, participants are followed up every 3 months for 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of Lacosamide for Seizure Prophylaxis in Patients With High-Grade Gliomas
Actual Study Start Date : July 25, 2012
Actual Primary Completion Date : June 20, 2017
Actual Study Completion Date : June 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures
Drug Information available for: Lacosamide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm I (lacosamide)
Participants receive lacosamide PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
 Drug: Lacosamide
Given PO
Other Names:
  • ADD 234037
  • Erlosamide
  • Harkoseride
  • SPM 927
  • Vimpat
Placebo Comparator: Arm II (placebo)
Participants receive a placebo PO BID for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
 Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Seizures [ Time Frame: 12 months or first seizure ]
    Number of Participants that had seizure in a randomized, two-arm, parallel groups of post-operative participants with newly-diagnosed high-grade glioma (HGG)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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. f) Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (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.
  • 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.
  • Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism.
  • Patients must not have a history of heart block or cardiac arrhythmia, including asymptomatic arrhythmias and atrial fibrillation/flutter.
  • Patients must not have a prolonged PR interval (defined as > 200 ms).
  • Perioperative anticonvulsants should be tapered as indicated in the protocol.
  • Patients must not have a history of any type of seizure for at least 10 years prior to registration.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432171


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marta Penas-Prado M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by M.D. Anderson Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] May 30, 2014

More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01432171    
Other Study ID Numbers: BTTC11-01
NCI-2018-01854 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
BTTC11-01 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2011    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: December 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Seizures
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Neurologic Manifestations
Nervous System Diseases
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action