Trial Outcomes & Findings for Perampanel in Seizure Patients With Primary Glial Brain Tumors (NCT NCT02363933)
NCT ID: NCT02363933
Last Updated: 2018-04-27
Results Overview
The primary objective of this study is to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity. Efficacy will be assessed by the 50% responder rate, defined as the percentage of patients with a ≥50% seizure reduction during the maintenance period compared with the seizure frequency before initiation of perampanel. Seizure frequency during maintenance perampanel will be computed as the ratio of the total number of seizure episodes while receiving perampanel during the maintenance period and the number of days perampanel is administered
COMPLETED
PHASE4
9 participants
20 Weeks
2018-04-27
Participant Flow
1 subject decided not to participate-had no more seizures after enrolling/while waiting to start
Participant milestones
| Measure |
Perampanel + Current Anti-Epileptic Drug
Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.
Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perampanel in Seizure Patients With Primary Glial Brain Tumors
Baseline characteristics by cohort
| Measure |
Perampanel + Current Anti-Epileptic Drug
n=8 Participants
Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.
Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
45.0 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 WeeksPopulation: Seizure frequency was not systematically gathered at screening. As the 50% responder rate requires an adequate baseline comparison, it is not possible to compute the 50% responder rate.
The primary objective of this study is to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma presenting refractory partial onset seizure activity. Efficacy will be assessed by the 50% responder rate, defined as the percentage of patients with a ≥50% seizure reduction during the maintenance period compared with the seizure frequency before initiation of perampanel. Seizure frequency during maintenance perampanel will be computed as the ratio of the total number of seizure episodes while receiving perampanel during the maintenance period and the number of days perampanel is administered
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 WeeksPopulation: All patients treated with perampanel is included in the attributable adverse event rate.
The percentage of patients with unacceptable adverse events that are possibly, probably, or definitely related to perampanel treatment will be calculated. Unacceptable adverse events include all Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 4 or 5 toxicities that are possibly, probably, or definitely related to perampanel, as well as suicidal ideation (any grade) or suicide attempt (Grade 3-5).
Outcome measures
| Measure |
Perampanel + Current Anti-Epileptic Drug
n=8 Participants
Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.
Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
|
|---|---|
|
Percentage of Patients Who Experience a Adverse Event Possibly, Probably, or Definitely Attributable to Perampanel Treatment
|
0 percentage of participants
|
Adverse Events
Perampanel + Current Anti-Epileptic Drug
Serious adverse events
| Measure |
Perampanel + Current Anti-Epileptic Drug
n=8 participants at risk
Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.
Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
|
|---|---|
|
General disorders
Multi-organ failure
|
12.5%
1/8 • 24 Weeks
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
12.5%
1/8 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
12.5%
1/8 • 24 Weeks
|
Other adverse events
| Measure |
Perampanel + Current Anti-Epileptic Drug
n=8 participants at risk
Primary glioma patients will receive perampanel along with their current AED for a total of 20 weeks. Perampanel will be titrated from 2 mg in weeks 1 and 2 and up to 8 mg daily by week 5 if well tolerated by the patient. They will then receive a maintenance dose of 8 mg per day through 16 weeks. After 16 weeks, subjects will be tapered off perampanel over a 4 week period.
Perampanel: Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
|
|---|---|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Eye disorders
Eye disorders - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Hemorrhoids
|
12.5%
1/8 • 24 Weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • 24 Weeks
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • 24 Weeks
|
|
General disorders
Fatigue
|
75.0%
6/8 • 24 Weeks
|
|
Infections and infestations
Mucosal infection
|
25.0%
2/8 • 24 Weeks
|
|
Infections and infestations
Sinusitis
|
12.5%
1/8 • 24 Weeks
|
|
Infections and infestations
Upper respiratory infection
|
12.5%
1/8 • 24 Weeks
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • 24 Weeks
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • 24 Weeks
|
|
Investigations
Anemia
|
12.5%
1/8 • 24 Weeks
|
|
Investigations
Anmia
|
12.5%
1/8 • 24 Weeks
|
|
Investigations
Creatinine increased
|
25.0%
2/8 • 24 Weeks
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • 24 Weeks
|
|
Investigations
Platelet count decreased
|
37.5%
3/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
37.5%
3/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.5%
1/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • 24 Weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • 24 Weeks
|
|
Nervous system disorders
Dysphasia
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Facial nerve disorder
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
25.0%
2/8 • 24 Weeks
|
|
Nervous system disorders
Pyramidal tract syndrome
|
25.0%
2/8 • 24 Weeks
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • 24 Weeks
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8 • 24 Weeks
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • 24 Weeks
|
|
Psychiatric disorders
Confusion
|
25.0%
2/8 • 24 Weeks
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • 24 Weeks
|
|
Renal and urinary disorders
Hematuria
|
12.5%
1/8 • 24 Weeks
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • 24 Weeks
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
12.5%
1/8 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
12.5%
1/8 • 24 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • 24 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
12.5%
1/8 • 24 Weeks
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • 24 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place