Intractable EpilepsyPhase 4NCT04650204
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
A Phase 4 study testing Anticonvulsant Agent, Perampanel and Quality-of-Life Assessment in people with Intractable Epilepsy and Malignant Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intractable Epilepsy, Malignant Glioma, Seizure Disorder
- What is being tested?
- Anticonvulsant Agent, Perampanel and Quality-of-Life Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2020to 30 Apr 2023
- Phase
- Phase 4
- 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 subject, or the subject's legally acceptable representative is willing to participate in a clinical trial, provides written informed consent, and subject provides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects. In the event of subject lacking the capacity or losing the ability to consent, consent will be deferred to subject's legally acceptable representative
- Subjects that meet the following diagnostic criteria:
- Patients with established clinical diagnoses of biopsy-proven high-grade glioma (grade II or above) and epilepsy refractory to at least 1, drug with a seizure frequency of at least 1 seizure episode per month prior to baseline visit
- Subjects with body weight of >= 40 kg and =< 125 kg at screening
- Adults age 18 and older
Who cannot join
- Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, or other medical condition as determined by the investigator to potentially interfere with the study
- Subjects with glioblastoma not following Stupp protocol for treatment of glioblastoma
- History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus
- Past medical history of drug and/or alcohol abuse
- Pregnant or breast-feeding
- Subjects treated with PER prior to baseline
Show all 14Show fewer
- Prior felony conviction disclosed by the patient or previously stated in medical record
- History of violent behavior
- Clinically significant laboratory abnormality at screening or baseline visits, as determined by the investigators
- Use of an investigational drug or device within 20 days prior to treatment day 1
- Repeated radiation therapy for tumor regrowth
- Subjects that plan to undergo tumor resection on or after baseline visit
- Uncontrolled psychiatric disorder at baseline
- Subjects who report active suicidal attempts or suicidality including subjects with a history of suicide attempts or suicidality determined to be clinically significant by investigators at screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
About this study
Official title: A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma
This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone.
Read the detailed description
PRIMARY OBJECTIVE:
- Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs).
SECONDARY OBJECTIVES:
- To assess the change in neurocognitive function and brain magnetic resonance imaging (MRI) progression over the course of PER treatment with a daily dose of 4 mg (up to -8mg) in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs.
II. To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma (i.e., IDH-mutant versus [vs] wildtype).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive perampanel orally (PO) once daily (QD) for 40 weeks in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
- Conditions
- Intractable Epilepsy, Malignant Glioma, Seizure Disorder, WHO Grade 2 Glioma, WHO Grade 3 Glioma
- Being tested
- Anticonvulsant Agent, Perampanel, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Drug Resistant Epilepsy, Glioma, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticonvulsant AgentDrug
Also called Anti-seizure agent, anticonvulsant, Anticonvulsant Agents, Anticonvulsants
Given ASD
PerampanelDrug
Also called E2007, Fycompa
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (perampanel) | Experimental | Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Perampanel; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm B (ASD) | Active comparator | Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: Anticonvulsant Agent; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)
Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value < 0.05 will be used to reflect statistical significance.
Measured: At 3 months
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs
Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value < 0.05 will be used to reflect statistical significance.
Measured: At 6 months
Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
Measured: At 3 months
Decline in Neuropsychological Function
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start4 Dec 2020
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: The funding sponsor, EISAI, sold the US rights to the medication and can no longer provide it to patients for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intractable EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Tatum, DO, Mayo Clinic
- Investigators
- William Tatum, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650204
- Sponsor's protocol ID
- 19-006286
- Other IDs
- NCI-2020-01290, MC2072
- Status last verified
- May 2023
- First submitted
- 11 Nov 2020
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma
- ClinicalTrials.gov ID
- NCT04650204
- Acronym / sponsor ID
- 19-006286
- Conditions
- Intractable Epilepsy, Malignant Glioma, Seizure Disorder, WHO Grade 2 Glioma, WHO Grade 3 Glioma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The funding sponsor, EISAI, sold the US rights to the medication and can no longer provide it to patients for the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone.
Detailed description
PRIMARY OBJECTIVE:
- Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs).
SECONDARY OBJECTIVES:
- To assess the change in neurocognitive function and brain magnetic resonance imaging (MRI) progression over the course of PER treatment with a daily dose of 4 mg (up to -8mg) in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs.
II. To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma (i.e., IDH-mutant versus [vs] wildtype).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP A: Patients receive perampanel orally (PO) once daily (QD) for 40 weeks in the absence of disease progression or unacceptable toxicity.
GROUP B: Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (perampanel) | Experimental | Drug: Perampanel, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm B (ASD) | Active comparator | Drug: Anticonvulsant Agent, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject, or the subject's legally acceptable representative is willing to participate in a clinical trial, provides written informed consent, and subject provides written assent, as required by the Mayo Clinic Institutional Review Board (IRB) policy involving human subjects. In the event of subject lacking the capacity or losing the ability to consent, consent will be deferred to subject's legally acceptable representative
- Subjects that meet the following diagnostic criteria:
- Subjects with body weight of >= 40 kg and =< 125 kg at screening
- Adults age 18 and older
Key exclusion criteria (14 listed)
- Subject has serious cardiac, respiratory, renal, gastrointestinal, hematologic, or other medical condition as determined by the investigator to potentially interfere with the study
- Subjects with glioblastoma not following Stupp protocol for treatment of glioblastoma
- History of status epilepticus in the 6 months prior to screening or a history of seizure clusters progressing to status epilepticus
- Past medical history of drug and/or alcohol abuse
- Pregnant or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticonvulsant AgentAlso: Anti-seizure agent, anticonvulsant, Anticonvulsant Agents, AnticonvulsantsGiven ASD | Drug | Arm B (ASD) |
| PerampanelAlso: E2007, FycompaGiven PO | Drug | Arm A (perampanel) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm A (perampanel), Arm B (ASD) |
| Questionnaire AdministrationAncillary studies | Other | Arm A (perampanel), Arm B (ASD) |
Primary outcome
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)
Time frame: At 3 months
Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value < 0.05 will be used to reflect statistical significance.
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs
Time frame: At 6 months
Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value < 0.05 will be used to reflect statistical significance.
Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER
Time frame: At 3 months
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
Decline in Neuropsychological Function
Time frame: At 6 months
Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Tatum principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Anticonvulsant Agent, Perampanel and Quality-of-Life Assessment in people with Intractable Epilepsy and Malignant Glioma, run by Mayo Clinic at 1 site 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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 22 Jun 2023). 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?
Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs) (time frame: At 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.