Fycompa Titration Intervals and Effects on Retention Rate



Status:Recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 75
Updated:5/9/2018
Start Date:April 18, 2018
End Date:March 2020
Contact:Stephanie L Marsh, BS, CCRC
Email:stephanie.marsh@bannerhealth.com
Phone:602-769-7580

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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).

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.

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).
We found this trial at
1
site
Phoenix, Arizona 85006
Principal Investigator: Norman C Wang, MD
Phone: 602-521-3237
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mi
from
Phoenix, AZ
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