Trial Outcomes & Findings for Fycompa Titration Intervals and Effects on Retention Rate (NCT NCT03457129)
NCT ID: NCT03457129
Last Updated: 2023-08-15
Results Overview
Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2023-08-15
Participant Flow
Participant milestones
| Measure |
Fycompa 2 Week Titration Intervals
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fycompa Titration Intervals and Effects on Retention Rate
Baseline characteristics by cohort
| Measure |
Fycompa 2 Week Titration Intervals
n=10 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=10 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
33 years
STANDARD_DEVIATION 11 • n=5 Participants
|
43 years
STANDARD_DEVIATION 9 • n=7 Participants
|
37 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksRetention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.
Outcome measures
| Measure |
Fycompa 2 Week Titration Intervals
n=7 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=8 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksAdverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.
Outcome measures
| Measure |
Fycompa 2 Week Titration Intervals
n=10 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=10 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].
|
4 participants
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 52 weeksPopulation: 2 participants in Group A were discontinued due to adverse events and 3 were lost to follow-up. In group B, 3 participants were discontinued due to adverse events and 2 were lost to follow-up. Therefore, only 5 participants remained in each treatment group for determination of seizure frequency during the final maintenance phase.
The average of seizures per week will be calculated starting at initial titration through final maintenance \[Efficacy\]."
Outcome measures
| Measure |
Fycompa 2 Week Titration Intervals
n=5 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=5 Participants
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
Seizures Frequency Per Week
|
0.912 Seizures per week
Standard Deviation 0.647
|
0.508 Seizures per week
Standard Deviation 0.887
|
Adverse Events
Fycompa 2 Week Titration Intervals
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Fycompa 3 Week Titration Intervals
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fycompa 2 Week Titration Intervals
n=10 participants at risk
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=10 participants at risk
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
Nervous system disorders
Intractable Seizures
|
0.00%
0/10 • Up to 52 weeks
|
10.0%
1/10 • Number of events 1 • Up to 52 weeks
|
Other adverse events
| Measure |
Fycompa 2 Week Titration Intervals
n=10 participants at risk
Perampanel oral tablet: 2mg by mouth every 24 hours for two weeks, then up-titrated by 2 mg every two weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
Fycompa 3 Week Titration Intervals
n=10 participants at risk
Perampanel oral tablet: 2mg by mouth every 24 hours for three weeks, then up-titrated by 2 mg every three weeks to a target dose of 6 mg/day. Minimum total daily dose = 2 mg/day. Maximum daily dose is 12 mg/day. Total daily dose will be determined by the Investigator based on tolerability and seizure control.
Perampanel Oral Tablet: Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
|
|---|---|---|
|
Psychiatric disorders
Anger
|
40.0%
4/10 • Up to 52 weeks
|
30.0%
3/10 • Up to 52 weeks
|
|
Nervous system disorders
Drowsiness
|
20.0%
2/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Nervous system disorders
Dizziness
|
20.0%
2/10 • Up to 52 weeks
|
30.0%
3/10 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
2/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Nervous system disorders
Numbness
|
0.00%
0/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Nervous system disorders
Unsteadiness
|
0.00%
0/10 • Up to 52 weeks
|
30.0%
3/10 • Up to 52 weeks
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Nervous system disorders
Memory difficulty
|
0.00%
0/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Nervous system disorders
Anxiety
|
10.0%
1/10 • Up to 52 weeks
|
0.00%
0/10 • Up to 52 weeks
|
|
Reproductive system and breast disorders
Abnormal menses
|
10.0%
1/10 • Up to 52 weeks
|
0.00%
0/10 • Up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
1/10 • Up to 52 weeks
|
0.00%
0/10 • Up to 52 weeks
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
10.0%
1/10 • Up to 52 weeks
|
0.00%
0/10 • Up to 52 weeks
|
|
Nervous system disorders
Speech difficulty
|
10.0%
1/10 • Up to 52 weeks
|
0.00%
0/10 • Up to 52 weeks
|
|
Nervous system disorders
Sleep difficulty
|
10.0%
1/10 • Up to 52 weeks
|
10.0%
1/10 • Up to 52 weeks
|
|
Infections and infestations
Head cold
|
10.0%
1/10 • Number of events 1 • Up to 52 weeks
|
30.0%
3/10 • Number of events 5 • Up to 52 weeks
|
Additional Information
Stephanie Marsh, MPH, CCRC
University of Arizona, College of Medicine Phoenix
Phone: 602-255-7552
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place