Post-market Study of AMPA Receptor Antagonists for Epilepsy Patients in Hong Kong

NCT03457961 | Unknown DMC FDA Drug

• 1 other identifier: 2016-HL-001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Epilepsy is a chronic neurological disease which affects approximately 70,000 patients in Hong Kong and 50 billion people worldwide. Among these patients one-third remained unresponsive to antiepileptic agents. Continual drug manipulation is an essential therapeutic option for these patients with refractory epilepsy. In particular, rational polytherapy has become the mainstay of treatment for the sub-group of patients who have failed two or more antiepileptic drugs (AEDs). A substantial amount of research has shown that N-methyl-D-aspartate receptors (NMDA) may play a key role in the pathophysiology of several neurological diseases, including epilepsy. Animal models of epilepsy and clinical studies demonstrate that NMDA receptors activity and expression can be altered in association with epilepsy and particularly in some specific seizure types. NMDA receptor antagonists have been shown to have antiepileptic effects in both clinical and preclinical studies. There is some evidence that conventional antiepileptic drugs may also affect NMDA receptor function. Aims: To investigate the medium to long-term effects of AMPA/NMDA receptor antagonist in an Asian cohort as there is a relative lack of clinical data in this population To explore the efficacy of AMPA/NMDA receptor antagonist in patients with partial onsets seizures that may secondarily generalize and the specific side effects of AMPA/NMDA receptor antagonist in relation to behavioral problems. Methods: A semi-prospective design is adopted to recruit patients who are indicated and started on AMPA/NMDA receptor antagonist aged 12 or above in Hong Kong. This study will collect information about demographic details, medical history and seizure information. Assessment of seizure frequency is based on seizure diary and interviews with family members. Physical examination, electrocardiogram and other medical information relevant to the follow-up of the patient will be collected.

Conditions

Focal Epilepsy; Generalized Epilepsy; Partial Seizures, Simple

Keywords

Perampanel; focal onset seizure; epilepsy

Outcome Measures

Primary Outcomes (2)

• Efficacy end-points

  The primary efficacy end-points evaluates seizure frequency (per month) in week 0 (baseline) and week 16 (maintenance phase). The investigators will used those seizure frequencies (per month) to calculate the percentage change from baseline to maintenance phase for each subject and categories: no change, between 0 to 50% decrease, 50% to 75% decrease, 75% to 100% decrease.

  16 weeks

• Seizure freedom rate in study population

  The proportion of subjects achieving seizure freedom during the maintenance period will be documented. The percentage of seizure free days in the maintenance phase will also be collected. The investigators will report the seizure freedom rate for the present study population and the average days of achieving seizure freedom.

  16 weeks

Secondary Outcomes (1)

• Psychiatric and behavioral adverse events

  16 weeks

Study Arms (1)

Adjunctive Perampanel

A group of patients who aged 12 years or above and have a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures

Drug: Perampanel

Interventions

Perampanel DRUG

This study collects clinical information during the first 16 weeks after the first dose of AMPA/NMDA receptor antagonist. Subjects or caregivers shall provide seizure diary which documents seizure type and seizure frequency as per usual medical care. The final visit will be based on the week-16 visit.

Also known as: Fycompa

Adjunctive Perampanel

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (diagnosed epilepsy with simple partial seizure) who have a baseline seizure rate of more than 2 months would be provided perampanel as adjunctive treatment.

You may qualify if:

• Subject aged 12 years or above
• Subject has a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures
• Subjects who have a baseline seizure rate of more than 2 per month in the eight week period preceding the start of AMPA / NMDA receptor antagonist
• No seizure free period longer than 21 days during the eight week period before AMPA receptor antagonist was started
• Patients who already had neuropsychiatric inventory completed twice during the treatment period spanning at least 16 weeks.

You may not qualify if:

• Subjects with idiopathic generalised epilepsy (for example, juvenile myoclonic epilepsy and absence epilepsy)
• Patients who only suffer from isolated auras
• Baseline creatinine clearance of less than 50ml/min
• Severe hepatic impairment with ALT three times the upper limits of normal
• Significant psychiatric conditions before the start of AMPA / NMDA receptor antagonist
• Progressive neurodegenerative conditions
• Active history of malignancy
• History of severe haematological conditions or serious blood dyscrasias
• Corrected QT interval more than 450 milli-second on ECG
• Substance abuse
• Pregnancy, breastfeeding

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, 0000, Hong Kong

RECRUITING

Related Publications (3)

• Steinhoff BJ, Bacher M, Bast T, Kornmeier R, Kurth C, Scholly J, Staack AM, Wisniewski I. First clinical experiences with perampanel--the Kork experience in 74 patients. Epilepsia. 2014 Jan;55 Suppl 1:16-8. doi: 10.1111/epi.12492.

  PMID: 24400693 BACKGROUND

• Juhl S, Rubboli G. Perampanel as add-on treatment in refractory focal epilepsy. The Dianalund experience. Acta Neurol Scand. 2016 Nov;134(5):374-377. doi: 10.1111/ane.12558. Epub 2016 Jan 13.

  PMID: 26763771 BACKGROUND

• Trinka E, Steinhoff BJ, Nikanorova M, Brodie MJ. Perampanel for focal epilepsy: insights from early clinical experience. Acta Neurol Scand. 2016 Mar;133(3):160-72. doi: 10.1111/ane.12529. Epub 2015 Oct 28.

  PMID: 26506904 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy, Generalized; Seizures; Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ho Wan Leung

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sau Man Celia Tse

CONTACT

85257431802; saumanceliatse@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: March 8, 2018
• Study Start: July 23, 2016
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)