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Fycompa Titration Intervals and Effects on Retention Rate

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ClinicalTrials.gov Identifier: NCT03457129
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : May 7, 2018
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
Stephanie Marsh, University of Arizona

Brief 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).

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Perampanel Oral Tablet Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fycompa Titration Intervals and Effects on Retention Rate
Actual Study Start Date : April 18, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Perampanel

Arm Intervention/treatment
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
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.
Other Name: Fycompa

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
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.
Other Name: Fycompa




Primary Outcome Measures :
  1. The percentage of subjects completing 52 weeks of adjunctive therapy during the maintenance phase [Retention Rate]. [ Time Frame: Up to 52 weeks ]
    Retention rate, which indirectly measures the therapeutic tolerance, will be measured at 52 weeks in each group.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events (TEAEs) reported by the subject or observed by the investigator [Safety and Tolerability]. [ Time Frame: Up to 52 weeks ]
    Adverse events experienced in each group will be tabulated and the total percentage of subjects reporting adverse events will be calculated.

  2. Seizure frequency per 28 days during initial titration and final maintenance will be calculated [Efficacy]. [ Time Frame: Up to 52 weeks ]
    Seizure frequency will be calculated per 28 days in each group during the initial titration phase and during the final maintenance phase.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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).

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): NCT03457129


Contacts
Contact: Stephanie L Marsh, BS, CCRC 602-769-7580 stephanie.marsh@bannerhealth.com
Contact: Anna T Valencia, MPH, MBEMH 520-780-8241 atvalencia@email.arizona.edu

Locations
United States, Arizona
Banner University Medical Center Phoenix Recruiting
Phoenix, Arizona, United States, 85006
Contact: Stephanie L Marsh, BS, CCRC    602-521-3237    stephanie.marsh@bannerhealth.com   
Contact: Anna Valencia, MPH, MBEMH    520-780-8241 ext T    atvalencia@email.arizona.edu   
Principal Investigator: Norman C Wang, MD         
Sub-Investigator: Hussam Seif-Eddeine, MD         
Sub-Investigator: Steve S Chung, MD         
Sponsors and Collaborators
University of Arizona
Eisai Inc.
Investigators
Principal Investigator: Norman C Wang, MD Banner University Medical Center

Responsible Party: Stephanie Marsh, Clinical Research Coordinator, University of Arizona
ClinicalTrials.gov Identifier: NCT03457129     History of Changes
Other Study ID Numbers: Fycompa Titration IIS
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: At this time, there is no plan to share individual participant data with other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Stephanie Marsh, University of Arizona:
Epilepsy
Epilepsy, partial onset
Epilepsy, generalized onset
Fycompa
perampanel

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases