Study 505, a Post-Marketing Surveillance Study of Perampanel Film-Coated Tablets and Oral Suspension in Korean Patients: Study Design
Abstract number :
3.272
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825612
Source :
www.aesnet.org
Presentation date :
12/9/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Authors :
Sang Kun Lee, MD, PhD - Seoul National University Hospital; Ji Hyun Kim, MD, PhD – Korea University Guro Hospital; Dae-Won Seo, MD, PhD – Samsung Medical Center, Sungkyunkwan University School of Medicine; Dong Wook Kim, MD – Konkuk University School of Medicine; Minhee Lee, Bachelor of Nursing – Eisai Korea Inc.; Seung Bong Hong, MD, PhD – Samsung Medical Center, Sungkyunkwan University School of Medicine; Kyoung Heo, MD, PhD – Severance Hospital, Yonsei University College of Medicine
Rationale: In the US and Korea, perampanel is approved for focal-onset seizures (FOS) (adjunctive and monotherapy) in patients aged ≥ 4 years, and adjunctive treatment of generalized tonic-clonic seizures (GTCS) in patients aged ≥ 12 (≥ 7, Korea) years. Study 505 (NCT02722590) is an ongoing post-marketing surveillance study of perampanel film-coated tablets and oral suspension in Korean patients with FOS, with or without focal to bilateral tonic-clonic seizures (FBTCS), or GTCS to further assess the safety profile and effectiveness of perampanel during routine clinical care. Here, we present the design of Study 505.
Methods: Study 505 will be conducted at ≥ 30 sites in Korea that prescribe perampanel. Patients who have given written consent and meet the approved indication for perampanel in Korea are eligible for inclusion: monotherapy (film-coated tablets) for FOS (with/without FBTCS) in patients aged ≥ 4 years; adjunctive therapy (film-coated tablets or oral suspension) for FOS (with/without FBTCS) in patients aged ≥ 4 years or GTCS in patients aged ≥ 7 years. Exclusion criteria: hypersensitivity to perampanel; patients with lactose (film-coated tablets) or fructose (oral suspension) intolerances; patients judged not able to participate in the study by their doctor. Patients will be monitored for up to 24 weeks from the first perampanel dose after consent and for 4 weeks after discontinuation if perampanel is discontinued during the Treatment Period. Patients who receive perampanel for ≥ 24 weeks after their first dose will be classified as long-term users. Patients who receive ≥ 1 dose of perampanel and provide safety information at any visit after perampanel administration will be included in the safety population. Safety assessments include monitoring adverse events (AEs), treatment-related AEs, serious AEs, and adverse drug reactions reported during the Treatment and Follow-up Periods. AEs related to abuse or dependency (based on Medical Dictionary for Regulatory Activities terms) will also be assessed. Subgroup analyses for the following groups will be performed: pediatric, geriatric, pregnant, renal impairment, hepatic impairment, and others. Analyses based on baseline factors such as diagnosis, treatment factors, long-term use, medical history, dosage form, dose/administration, and concomitant medication are also planned. Efficacy will be measured by the Investigator’s Clinical Global Impression of Change at 12 weeks (± 7 days) and 24 weeks (± 7 days) in patients from the safety population who received perampanel for ≥ 12 weeks.
Results: Study 505 initiated on July 1, 2016 and is expected to complete in July 2021. Anticipated enrollment is 3000 patients (FOS, n=2700; GTCS, n=300), of whom 300 patients (FOS, n=270; GTCS, n=30) are expected to be long-term users of perampanel.
Conclusions: Study 505 will provide additional information related to the safety and efficacy profile of perampanel film-coated tablets and oral suspension in a routine clinical practice setting in Korea.
Funding: Please list any funding that was received in support of this abstract.: Eisai Korea Inc.
Anti-seizure Medications