CClinicalTrials.gg
Sign In
CompletedNCT03457129Updated Aug 15, 2023Results posted

Fycompa Titration Intervals and Effects on Retention Rate

A Phase 4 interventional study of Perampanel Oral Tablet in Epilepsy, sponsored by University of Arizona. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by University of Arizona · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals. Subjects will be randomized to either perampanel, standard titration interval rate (Group A) or perampanel, slower titration interval rate (Group B).

Read the detailed description

A total of 60 subjects with a confirmed diagnosis of either partial onset or primary generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day. Subjects in this group will be designated Group A. The remaining 30 subjects will also begin perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6 mg/day and will be designated Group B.

02

Conditions studied

  • Epilepsy

Browse trials for

Keywords

  • Epilepsy
  • Epilepsy, partial onset
  • Epilepsy, generalized onset
  • Fycompa
  • perampanel
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
  2. Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
  3. Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
  4. Subjects aged 18 to 75.
  5. Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
  6. Can be safely treated, in the opinion of the investigator, with Fycompa.
  7. Able and agrees to follow the specified titration schedule.
  8. Subjects or a legal guardian who is able to communicate effectively with study personnel and considered reliable, able, willing and cooperative with regard to complying with protocol-defined requirements, including completion of the study diary.

Exclusion criteria

Exclusion Criteria:

  1. Any history of non-epileptic or psychogenic seizures.
  2. Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
  3. Subjects with active suicidal ideation or behavior as evidenced by positive answers on the Columbia Suicide Severity Rating Scale (C-SSRS) or subject's with a history of suicidal ideation or attempt within 12 months.
  4. Subjects with a suicidal attempt in the 12 months prior to Visit 1
  5. Any clinically significant medical or psychiatric illness, psychological or behavioral problems, which in the opinion of the investigator would interfere with the subject's ability to participate in the study.
  6. Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
  7. Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    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.

    Drug: Perampanel Oral Tablet

  • Experimental
    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.

    Drug: Perampanel Oral Tablet

Interventions

  • DrugPerampanel 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.

    Also known as: Fycompa

05

What researchers measure

Primary outcomes

  1. The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].

    Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].

    Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.

    Time frame: Up to 52 weeks

  2. Seizures Frequency Per Week

    The average of seizures per week will be calculated starting at initial titration through final maintenance \[Efficacy\]."

    Time frame: Up to 52 weeks

06

Results

Posted Dec 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
Started1010
Completed78
Not completed32

Outcome measures

PrimaryThe Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].

Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].
ParticipantsFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate].23
SecondaryIncidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].

Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.

Time frame:
Up to 52 weeks
Reported as:
Number · participants
Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].
participantsFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability].43
SecondarySeizures Frequency Per Week

The average of seizures per week will be calculated starting at initial titration through final maintenance \[Efficacy\]."

Time frame:
Up to 52 weeks
Reported as:
Mean · Seizures per week
Seizures Frequency Per Week
Seizures per weekFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
Seizures Frequency Per Week0.912 ± 0.6470.508 ± 0.887

Adverse events

Collected over Up to 52 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fycompa 2 Week Titration Intervals0/10 (0%)0/10 (0%)4/10 (40%)
Fycompa 3 Week Titration Intervals0/10 (0%)1/10 (10%)3/10 (30%)
Most frequent serious events
Most frequent serious events
EventFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
Intractable SeizuresNervous system disorders0/101/10
Most frequent other events
Showing 10 of 16
Most frequent other events
EventFycompa 2 Week Titration IntervalsFycompa 3 Week Titration Intervals
AngerPsychiatric disorders4/103/10
DizzinessNervous system disorders2/103/10
UnsteadinessNervous system disorders0/103/10
Head coldInfections and infestations1/103/10
DrowsinessNervous system disorders2/101/10
Back painMusculoskeletal and connective tissue disorders2/101/10
NumbnessNervous system disorders0/101/10
NauseaGastrointestinal disorders1/101/10
Memory difficultyNervous system disorders0/101/10
AnxietyNervous system disorders1/100/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Fycompa 2 Week Titration IntervalsFycompa 3 Week Titration IntervalsTotal
<=18 years000
Between 18 and 65 years101020
>=65 years000
Age, Continuous
Age, Continuous(years)Fycompa 2 Week Titration IntervalsFycompa 3 Week Titration IntervalsTotal
Mean33 ± 1143 ± 937 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Fycompa 2 Week Titration IntervalsFycompa 3 Week Titration IntervalsTotal
Female6410
Male4610
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fycompa 2 Week Titration IntervalsFycompa 3 Week Titration IntervalsTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American000
White81018
More than one race202
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Fycompa 2 Week Titration IntervalsFycompa 3 Week Titration IntervalsTotal
United States101020
07

Study locations

1 site
  • Banner University Medical Center Phoenix
    Phoenix, Arizona 85006, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 3, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — At this time, there is no plan to share individual participant data with other researchers.

09

Registry details

Key details

Study ID
NCT03457129
Lead sponsor
University of Arizona
Collaborators
Eisai Inc.
Responsible party
Stephanie Marsh (Clinical Research Coordinator, University of Arizona) — Principal investigator
First posted
Mar 7, 2018
Start date
Apr 18, 2018
Primary completion
Feb 24, 2021
Completion
Dec 15, 2021
Results posted
Dec 8, 2021
Last update
Aug 15, 2023

Study contacts

Norman C Wang, MD
principal investigator · Banner University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Epilepsy→

Other studies from this sponsor

University of Arizona

Start the discussion