Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01871233




Registration number
NCT01871233
Ethics application status
Date submitted
4/06/2013
Date registered
6/06/2013
Date last updated
16/04/2020

Titles & IDs
Public title
An Extended Access Program for Perampanel
Scientific title
An Extended Access Program for Perampanel
Secondary ID [1] 0 0
E2007-G000-401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Partial Onset 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
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Perampanel

Treatment: Drugs: Perampanel
Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in Studies 207, 307, or 235. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted based on clinical judgment. A minimum daily dose permitted will be 12 mg per day. Treatment will be prescribed as long as clinically appropriate according to the judgment of the treating physician and the approved summary of Product Characteristics (SmPC). Tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Patients will be instructed to take their perampanel tablets once daily, by mouth, before bedtime, and with food.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Patients who are participating in either Study 207, Study 307, or Study 235 and who in
the opinion of the treating physician, continue to benefit from treatment with
perampanel (revised per Amendment 01)

- Patients who provide informed consent where applicable per local requirements.

- Female patients of childbearing potential must agree for the duration of the program
and for a period of at least 1 month following last dose of perampanel to be abstinent
or to commit to the consistent and correct use of a medically acceptable method of
birth control (e.g., a double-barrier method [condom plus spermicide, condom plus
diaphragm with spermicide])
Minimum age
12 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Patients residing in countries where perampanel is commercially available for the
treatment of POS

- Female patients who are lactating, pregnant, or planning to become pregnant

Study design
Purpose of the study
Allocation to intervention
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?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [2] 0 0
- Fitzroy
Recruitment hospital [3] 0 0
Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre - Heidelberg
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
- Victoria
Recruitment postcode(s) [1] 0 0
VIC 3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
VIC 3081 - Heidelberg
Recruitment postcode(s) [4] 0 0
VIC 3050 - Parkville
Recruitment postcode(s) [5] 0 0
- Victoria
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Provincia De Mendoza
Country [2] 0 0
Argentina
State/province [2] 0 0
Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Argentina
State/province [4] 0 0
Rosario
Country [5] 0 0
Argentina
State/province [5] 0 0
San José Guaymallén
Country [6] 0 0
Argentina
State/province [6] 0 0
San Miguel de Tucumán
Country [7] 0 0
Belgium
State/province [7] 0 0
Edegem
Country [8] 0 0
Belgium
State/province [8] 0 0
Gent
Country [9] 0 0
Belgium
State/province [9] 0 0
Ghent
Country [10] 0 0
Belgium
State/province [10] 0 0
Ottignies
Country [11] 0 0
Canada
State/province [11] 0 0
Albert
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Calgary
Country [14] 0 0
Canada
State/province [14] 0 0
London, Ontario
Country [15] 0 0
Chile
State/province [15] 0 0
Puente Alto
Country [16] 0 0
Chile
State/province [16] 0 0
Santiago
Country [17] 0 0
Chile
State/province [17] 0 0
Valdivia
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno
Country [19] 0 0
Czechia
State/province [19] 0 0
Hradec Kralove
Country [20] 0 0
Czechia
State/province [20] 0 0
Ostrava
Country [21] 0 0
Czechia
State/province [21] 0 0
Prague
Country [22] 0 0
Estonia
State/province [22] 0 0
Laagri
Country [23] 0 0
Estonia
State/province [23] 0 0
Tallinn
Country [24] 0 0
Estonia
State/province [24] 0 0
Tartu
Country [25] 0 0
Finland
State/province [25] 0 0
Vantaa
Country [26] 0 0
Greece
State/province [26] 0 0
Greece
Country [27] 0 0
Hong Kong
State/province [27] 0 0
Kwai Chung
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Israel
State/province [29] 0 0
Ashkelon
Country [30] 0 0
Israel
State/province [30] 0 0
Haifa
Country [31] 0 0
Israel
State/province [31] 0 0
Holon
Country [32] 0 0
Israel
State/province [32] 0 0
Netanya
Country [33] 0 0
Italy
State/province [33] 0 0
Napoli
Country [34] 0 0
Latvia
State/province [34] 0 0
Prague
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
Kuala Lumpur
Country [41] 0 0
Malaysia
State/province [41] 0 0
Petaling Jaya
Country [42] 0 0
Netherlands
State/province [42] 0 0
Haarlem
Country [43] 0 0
Netherlands
State/province [43] 0 0
Heeze
Country [44] 0 0
Netherlands
State/province [44] 0 0
Hoofddorp
Country [45] 0 0
Poland
State/province [45] 0 0
Gdansk
Country [46] 0 0
Spain
State/province [46] 0 0
Albacete
Country [47] 0 0
Spain
State/province [47] 0 0
Granada
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
Taiwan
State/province [50] 0 0
Tainan
Country [51] 0 0
Taiwan
State/province [51] 0 0
Taiwan
Country [52] 0 0
Taiwan
State/province [52] 0 0
Taoyuan
Country [53] 0 0
Thailand
State/province [53] 0 0
Bangkok
Country [54] 0 0
Thailand
State/province [54] 0 0
Bangplee
Country [55] 0 0
Thailand
State/province [55] 0 0
Chiang Mai
Country [56] 0 0
Thailand
State/province [56] 0 0
Khonkaen

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

Ethics approval
Ethics application status

Summary
Brief summary
The Extended Access Program (EAP) is a managed access programme for Perampanel. The main
objective of this EAP is to ensure that patients participating in studies E2007-A001-207,
E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time
perampanel tablets become commercially available for the treatment of Partial Onset Seizures
(POS) in the country in which they reside. This EAP will consist of 2 phases:

- Screening: The patient will start the program once the Screening assessments are
completed and the patient is qualified for participation.

- Treatment: Additional assessments, physical examinations, and dosage changes will be
clinically determined by the treating physician.

Patients will enter this program on the same dose of perampanel that they were receiving at
the end of their participation in previous study. Doses of perampanel and of concomitant
anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based
on clinical judgment.

Treatment will be prescribed as long as clinically appropriate according to the judgement of
the treating physician and the approved Summary of Product Characteristics (SmPC).

The program will complete in a staggered fashion, country by country, as and when perampanel
becomes commercially available for the treatment of POS in each country.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01871233
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01871233