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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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13 December 2021 |
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Main ID: |
EUCTR2007-006170-28-FR |
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Date of registration:
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21/08/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A 14-Month Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (perampanel) Given as Adjunctive Therapy in Subjects with Refractory Partial Seizures
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Scientific title:
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A 14-Month Open-Label Extension Phase of the Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Studies to Evaluate the Efficacy and Safety of E2007 (perampanel) Given as Adjunctive Therapy in Subjects with Refractory Partial Seizures |
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Date of first enrolment:
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20/03/2009 |
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Target sample size:
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1430 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-006170-28 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Germany
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Greece
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Hungary
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Italy
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Latvia
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Lithuania
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Netherlands
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Portugal
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Spain
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Sweden
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Have completed Visit 8 of study E2007-G000-304, E2007-G000-305 study, or E2007-G000-306 and shown compliance with the inclusion and exclusion criteria for that study (excluding criteria that are related to seizure occurrences).
2. Provide written informed consent signed by subject or legal guardian prior to entering the study or undergoing any study procedures (If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained);
3. Be considered reliable and willing to be available for the study period and able to record seizures and report adverse events them self or have a caregiver who can record and report the events for them.
4. Females should be either of nonchildbearing potential (defined as having undergone surgical sterilization, or postmenopausal [>age 50 and amenorrheic for 12 months]) or of childbearing potential. For females of childbearing potential, they must agree to be abstinent or continue using at least 1 medically acceptable methods of contraception (eg, a double-barrier method [eg, condom + spermicide, condom + diaphragm with spermicide], IUD, or have a vasectomised partner) throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also continue using an additional approved method of contraception (as described previously) throughout the entire study period and for 2 months after the last dose of study drug. (It is not required for male subjects to use contraceptive measures based on preclinical toxicology data).
5. Continue to be treated with a stable dose of 1 or a maximum of 3 approved AEDs.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Those who, for any reason, discontinued early from the preceding double-blind study.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Epilepsy: refractory partial seizures with or without secondary generalisation
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Intervention(s)
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Product Name: Perampanel
Product Code: E2007, MARS
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Perampanel
Current Sponsor code: E2007
Other descriptive name: MARS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: Perampanel
Current Sponsor code: E2007
Other descriptive name: MARS
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: The primary objective is to evaluate the safety and tolerability of perampanel (up to12mg/day) given as adjunctive treatment in subjects with refractory partial seizures
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Primary end point(s): For subjects who were assigned to the perampanel treatment arms during the preceding double-blind studies, the following variables will be analyzed over the Double-blind Phase plus the Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to Pre-randomization Phase of the double-blind study. For subjects who were assigned to the placebo arms during the double-blind studies, the following variables will only be analyzed over the Open-label Treatment Phase (Conversion Period + Maintenance Period) relative to Pre-randomization Phase of the double-blind study:
1. Percent change in seizure frequency per 28 days
2. Proportion of patient who experience a 50% or greater reduction in seizure frequency per 28 days (responder rate analysis)
3. Percent change in seizure frequency per 28 days per seizure type
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Secondary Objective: The secondary objective is to evaluate the maintenance of effect of perampanel for the control of refractory partial seizures.
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Secondary ID(s)
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E2007-G000-307
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2007-006170-28-CZ
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 20/03/2009
Contact:
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