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Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures (FYC01S)

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ClinicalTrials.gov Identifier: NCT03059329
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:

The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

  1. unknown adverse drug reactions (ADRs);
  2. occurrence of ADRs;
  3. factors that are likely to affect safety and efficacy;
  4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
  5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

Condition or disease Intervention/treatment
Partial Seizures (With or Without Secondary Generalized Seizures) Primary Generalized Tonic-clonic Seizures Drug: Fycompa

Study Type : Observational
Estimated Enrollment : 3750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Perampanel

Group/Cohort Intervention/treatment
Fycompa-treated epilepsy participants
Adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa
Drug: Fycompa
The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.




Primary Outcome Measures :
  1. Number of participants with any serious adverse event [ Time Frame: from 0 to 52 weeks ]
  2. Number of participants with any non-serious adverse event [ Time Frame: from 0 to 52 weeks ]

Secondary Outcome Measures :
  1. Number of participants experiencing seizures [ Time Frame: from 0 to 52 weeks ]
  2. Overall improvement rating in seizure frequency [ Time Frame: from 0 to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with epilepsy who will receive Fycompa per the approved indication in routine clinical practice
Criteria

Inclusion Criteria:

  • Epilepsy participants at least 18 years of age with:

    • Partial seizures (with or without secondary generalized seizures)
    • Primary generalized Tonic-clonic seizures

Exclusion Criteria:

  • Participants previously treated with Fycompa

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): NCT03059329


Contacts
Contact: Customer Joy Department. EJ 81-120-161-454

Locations
Japan
Recruiting
Osaka, Japan
Recruiting
Tokyo, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Kenta Sumitomo Drug Fostering and Evolution Coordination Department. Medical Division

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT03059329     History of Changes
Other Study ID Numbers: E2007-M081-502
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
adult epilepsy participants
partial seizures
primary generalized Tonic-clonic seizures

Additional relevant MeSH terms:
Neoplasm Metastasis
Epilepsy
Seizures
Neoplastic Processes
Neoplasms
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms