Phase 4
Completed N=20
Fycompa Titration Intervals and Effects on Retention Rate
Source: ClinicalTrials.gov NCT03457129 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Dec 2021
Primary outcomePrimary: The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate]. — 2; 3 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Subjects Completing 52 Weeks of Adjunctive Therapy During the Maintenance Phase [Retention Rate]. |
2; 3 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events (TEAEs) Reported by the Subject or Observed by the Investigator [Safety and Tolerability]. |
4; 3 | — |
| SECONDARY Seizures Frequency Per Week |
0.912; 0.508 | — |
Eligibility Criteria
Inclusion Criteria
- Must provide written informed consent signed by the subject or legal guardian prior to entering the study in accordance with ICH and GCP guidelines.
- Subject has a confirmed diagnosis of medically refractory epilepsy with or without secondary generalization for at least 12 months prior to visit 1.
- Subjects currently being treated with 1 to 3 antiepileptic medications with or without VNS (does not count as an AED).
- Subjects aged 18 to 75.
- Subject's requiring an additional epilepsy medication due to either uncontrolled seizures and/or lack of tolerability with current epilepsy medications.
- Can be safely treated, in the opinion of the investigator, with Fycompa.
- Able and agrees to follow the specified titration schedule.
- 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
- Any history of non-epileptic or psychogenic seizures.
- Women who are currently pregnant, lactating or have plans to become pregnant in the immediate future.
- 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.
- Subjects with a suicidal attempt in the 12 months prior to Visit 1
- 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.
- Subjects with severe hepatic impairment or severe renal impairment or on hemodialysis.
- Any use of concomitant medication as listed in the drug insert, including medications known to be inducers of cytochrome P450 (CYP3A).
Data sourced from ClinicalTrials.gov (NCT03457129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.