Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00700310




Registration number
NCT00700310
Ethics application status
Date submitted
17/06/2008
Date registered
18/06/2008
Date last updated
21/01/2016

Titles & IDs
Public title
Evaluating Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Scientific title
A Double-Blind, Placebo-Controlled, Dose-Escalation, Parallel-Group Study to Evaluate the Efficacy and Safety of E2007 (Perampanel) Given as Adjunctive Therapy in Subjects With Refractory Partial Seizures
Secondary ID [1] 0 0
2007-006169-33
Secondary ID [2] 0 0
E2007-G000-306
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Partial Seizures 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - perampanel
Treatment: Drugs - perampanel
Treatment: Drugs - perampanel
Treatment: Drugs - Placebo

Active comparator: 1 -

Active comparator: 2 -

Active comparator: 3 -

Placebo comparator: 4 -


Treatment: Drugs: perampanel
2 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

Treatment: Drugs: perampanel
4 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

Treatment: Drugs: perampanel
8 mg perampanel or placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily and will be up-titrated weekly in 2-mg increments to their randomized dose.

Treatment: Drugs: Placebo
Placebo in a 1:1:1:1 ratio, 170 subjects/arm, a total of 680 subjects. All subjects will take a maximum of 6 tablets daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Change in the 28-day Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
Timepoint [1] 0 0
Baseline (Pre-randomization) through Week 19
Secondary outcome [1] 0 0
Responder Rate
Timepoint [1] 0 0
Baseline (Pre-randomization) through Week 19
Secondary outcome [2] 0 0
Percent Change in the 28-day Complex Partial Plus Secondarily Generalized Seizure Frequency From Baseline to the End of the Double-blind Phase (Titration and Maintenance Phases)
Timepoint [2] 0 0
Baseline (Pre-randomization) through Week 19

Eligibility
Key inclusion criteria
1. Provide written informed consent signed by the 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.).
2. Be considered reliable and willing to be available for the study period and able to record seizures and report AEs them self or have a caregiver who can record seizures and report AEs for them;
3. Male or female and greater than or equal to 12 years of age (within the course of the study), or greater than or equal to 18 years of age (depending on location) at the time of signing the informed consent.
4. Females should be either of non-childbearing potential (defined as having undergone surgical sterilization, or postmenopausal [age 50 and amenorrheic for 12 months]) or of childbearing potential. Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of childbearing potential must agree to be abstinent or to use 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) starting at Visit 1 and throughout the entire study period and for 2 months after the last dose of study drug. Those women using hormonal contraceptives must also be using an additional approved method of contraception (as described previously) starting at Visit 1 and continuing 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. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981). Diagnosis should have been established by clinical history and an electroencephalogram (EEG) that is consistent with localization-related epilepsy; normal interictal EEGs will be allowed provided that the subject meets the other diagnosis criterion (ie, clinical history);
6. Have had a computed tomography (CT) or magnetic resonance imaging (MRI) within the last 10 years that ruled out a progressive cause of epilepsy;
7. Have uncontrolled partial seizures despite having been treated with at least 2 different anti-epileptic drugs (AEDs) within approximately the last 2 years;
8. During the 6-week Pre-randomization Phase subjects must have had >/= 5 partial seizures per 6-week (with >/=2 partial seizures per each of 3-week period) and with no 25-day seizure-free period in the 6-week period, as documented via a valid seizure diary. Only simple partial seizures with motor signs, complex partial seizures, and complex partial seizures with secondary generalization are counted toward this inclusion;
9. Are currently being treated with stable doses of 1, 2 or a maximum of 3 approved AEDs. Only 1 inducer AED (defined as; carbamazepine, phenytoin, phenobarbital, or primidone only) out of the maximum of 3 AEDs is allowed;
10. Are on a stable dose of the same concomitant AED(s) for 1 month (or no less than 21 days) prior to Visit 1; in the case where a new AED regime has been initiated for a subject, the dose must be stable for 2 months (or no less than 49 days) prior to Visit 1;
11. If on a stable dose (other than intermittent rescue use) of benzodiazepines for epilepsy (or for anxiety or sleep disorders) the prescribed dose must be stable for 1 month (or no less than 21 days) prior to Visit 1. (Note: the use of intermittent rescue benzodiazepines is defined in the exclusion criterion #22 below.) When used in these cases (epilepsy, anxiety or sleep disorders), benzodiazepines will be counted as 1 AED; therefore, only 1 or a maximum of 2 additional approved AEDs will be allowed;
12. A vagal nerve stimulator (VNS) is allowed but it must have been implanted >/= 5 months prior to Visit 1. Stimulator parameters can not be changed for 1 month (or no less than 21 days) prior to Visit 1 or thereafter during the study.
Minimum age
12 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participated in a study involving administration of an investigational compound or device within 1 month (or no less than 21 days) prior to Visit 1, or within approximately 5 half-lives of the previous investigational compound, whichever is longer;
2. Pregnant and/or lactating;
3. Participated in previous perampanel studies;
4. Presence of nonmotor simple partial seizures only;
5. Presence of primary generalized epilepsies or seizures, such as absences and or myoclonic epilepsies;
6. Presence or previous history of Lennox-Gastaut syndrome;
7. A history of status epilepticus within approximately 12 months prior to Visit 1;
8. Seizure clusters where individual seizures cannot be counted;
9. A history of psychogenic seizures;
10. Evidence of clinically significant disease (eg, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subject's safety or the study conduct;
11. Scheduled and/or confirmed to have epilepsy surgery within 6 months after Visit 1; however those who have previously documented "failed" epilepsy surgery will be allowed;
12. Evidence of significant active hepatic disease. Stable elevations of liver enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) due to concomitant medication(s) will be allowed if they are less than 3 times the upper limit of normal (ULN);
13. Evidence of significant active hematological disease; white blood cell (WBC) count <= 2500/µL (2.50 1E+09/L) or an absolute neutrophil count <= 1000/µL (1.00 1E+09/L);
14. A clinically significant ECG abnormality, including prolonged QTc defined as >450 msec;
15. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of antipsychotics or have had a suicide attempt(s) within the last 2 years.
16. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors;
17. History of drug or alcohol dependency or abuse within approximately the last 2 years;
18. Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (eg, Stevens-Johnson syndrome), hematological, or organ toxicity reactions;
19. If felbamate is used as a concomitant AED, subjects must be on felbamate for at least 2 years, with a stable dose for 2 months (or no less than 49 days) prior to Visit 1. They must not have a history of white blood cell (WBC) count below 2500/µL (2.50 1E+09/L), platelets below 100,000, liver function tests (LFTs) above 3 times the upper limit of normal (ULN), or other indication of hepatic or bone marrow dysfunction while receiving felbamate. If patients received felbamate in the past, it must have been discontinued 2 months (or no less than 49 days) prior to Visit 1;
20. Concomitant use of vigabatrin. Subjects who took vigabatrin in the past must be off vigabatrin for approximately 5 months prior to Visit 1 and must have documentation showing no evidence of a vigabatrin associated clinically significant abnormality in a visual perimetry test;
21. Concomitant use of barbiturates (except for seizure control indication) within 1 month (or no less than 21 days) prior to Visit 1;
22. Use of intermittent rescue benzodiazepines (ie, 1-2 doses over a 24-hr period considered one-time rescue) 2 or more times in a 1-month period prior to Visit 1; or
23. Any condition(s) that will make the subject, in the opinion of the Investigator, unsuitable for the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2010
Sample size
Target
Accrual to date
Final
712
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
- Woodville South
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Heidelberg
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- West Heidelberg
Recruitment hospital [8] 0 0
- Woodville
Recruitment postcode(s) [1] 0 0
5011 - Woodville South
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3081 - Heidelberg
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3081 - West Heidelberg
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Pleven
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Plovdiv
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Sofia
Country [4] 0 0
Czech Republic
State/province [4] 0 0
Brno
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Olomouc
Country [6] 0 0
Czech Republic
State/province [6] 0 0
Praha 4
Country [7] 0 0
Czech Republic
State/province [7] 0 0
Praha 5
Country [8] 0 0
Estonia
State/province [8] 0 0
Tallinn
Country [9] 0 0
Estonia
State/province [9] 0 0
Tartu
Country [10] 0 0
Germany
State/province [10] 0 0
Dusseldorf
Country [11] 0 0
Germany
State/province [11] 0 0
Kehl-Kork
Country [12] 0 0
Germany
State/province [12] 0 0
Konigstein-Falkenstein
Country [13] 0 0
Germany
State/province [13] 0 0
Mainz
Country [14] 0 0
Germany
State/province [14] 0 0
Marburg
Country [15] 0 0
Germany
State/province [15] 0 0
Munchen
Country [16] 0 0
Germany
State/province [16] 0 0
Ulm
Country [17] 0 0
Germany
State/province [17] 0 0
Westerstede
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Hong Kong
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Kowloon
Country [20] 0 0
Hong Kong
State/province [20] 0 0
Shatin
Country [21] 0 0
Hungary
State/province [21] 0 0
Budapest
Country [22] 0 0
Hungary
State/province [22] 0 0
Kecskemet
Country [23] 0 0
India
State/province [23] 0 0
Andhra Pradesh
Country [24] 0 0
India
State/province [24] 0 0
Maharashtra
Country [25] 0 0
India
State/province [25] 0 0
Rajasthan
Country [26] 0 0
India
State/province [26] 0 0
New Delhi
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Italy
State/province [28] 0 0
Napoli
Country [29] 0 0
Italy
State/province [29] 0 0
Padova
Country [30] 0 0
Italy
State/province [30] 0 0
Siena
Country [31] 0 0
Italy
State/province [31] 0 0
Torino
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Busan
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Daegu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Latvia
State/province [35] 0 0
Riga
Country [36] 0 0
Latvia
State/province [36] 0 0
Valmiera
Country [37] 0 0
Lithuania
State/province [37] 0 0
Kaunas
Country [38] 0 0
Lithuania
State/province [38] 0 0
Klaipeda
Country [39] 0 0
Lithuania
State/province [39] 0 0
Vilnius
Country [40] 0 0
Malaysia
State/province [40] 0 0
Terengganu
Country [41] 0 0
Malaysia
State/province [41] 0 0
Wilayah Persekutuan
Country [42] 0 0
Philippines
State/province [42] 0 0
Ermita
Country [43] 0 0
Philippines
State/province [43] 0 0
Makati City
Country [44] 0 0
Poland
State/province [44] 0 0
Bialystok
Country [45] 0 0
Poland
State/province [45] 0 0
Gdansk
Country [46] 0 0
Poland
State/province [46] 0 0
Katowice
Country [47] 0 0
Poland
State/province [47] 0 0
Lodz
Country [48] 0 0
Poland
State/province [48] 0 0
Lublin
Country [49] 0 0
Poland
State/province [49] 0 0
Warszawa
Country [50] 0 0
Portugal
State/province [50] 0 0
Coimbra
Country [51] 0 0
Portugal
State/province [51] 0 0
Lisboa
Country [52] 0 0
Portugal
State/province [52] 0 0
Porto
Country [53] 0 0
Romania
State/province [53] 0 0
Brasov
Country [54] 0 0
Romania
State/province [54] 0 0
Bucharest
Country [55] 0 0
Romania
State/province [55] 0 0
Cluj Napoca
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Ekaterinburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Moscow
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Samara
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Tyumen
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Yaroslavl
Country [61] 0 0
Serbia
State/province [61] 0 0
Belgrade
Country [62] 0 0
Serbia
State/province [62] 0 0
Nis
Country [63] 0 0
Serbia
State/province [63] 0 0
Novi Sad
Country [64] 0 0
Spain
State/province [64] 0 0
Andalucia
Country [65] 0 0
Spain
State/province [65] 0 0
Cataluna
Country [66] 0 0
Spain
State/province [66] 0 0
Comunidad de Madrid
Country [67] 0 0
Spain
State/province [67] 0 0
Comunidad Valenciana
Country [68] 0 0
Spain
State/province [68] 0 0
Barcelona
Country [69] 0 0
Spain
State/province [69] 0 0
Valencia
Country [70] 0 0
Taiwan
State/province [70] 0 0
Kaohsiung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Tainan
Country [73] 0 0
Taiwan
State/province [73] 0 0
Taoyuan
Country [74] 0 0
Thailand
State/province [74] 0 0
Bangkok
Country [75] 0 0
Thailand
State/province [75] 0 0
Chiang Mai
Country [76] 0 0
Thailand
State/province [76] 0 0
Khon Kaen
Country [77] 0 0
Thailand
State/province [77] 0 0
Muang District
Country [78] 0 0
Ukraine
State/province [78] 0 0
Dnipropetrovsk
Country [79] 0 0
Ukraine
State/province [79] 0 0
Donetsk
Country [80] 0 0
Ukraine
State/province [80] 0 0
Kharkiv
Country [81] 0 0
Ukraine
State/province [81] 0 0
Kyiv
Country [82] 0 0
Ukraine
State/province [82] 0 0
Lviv
Country [83] 0 0
Ukraine
State/province [83] 0 0
Uzhgorod

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Squillacote, M.D.
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00700310