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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01161524




Registration number
NCT01161524
Ethics application status
Date submitted
12/07/2010
Date registered
13/07/2010
Date last updated
15/05/2019

Titles & IDs
Public title
A Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics in Adolescents
Scientific title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Phase to Evaluate the Effect of Perampanel (E2007) on Cognition, Growth, Safety, Tolerability, and Pharmacokinetics When Administered as an Adjunctive Therapy in Adolescents (12 to Less Than 18 Years of Age) With Inadequately Controlled Partial-onset Seizures
Secondary ID [1] 0 0
E2007-G000-235
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

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

Experimental: Perampenal (Core Study) - Participants received perampanel 2 mg per day and up-titrated weekly in 2-mg increments to a target dose range of 8 to 12 mg per day.

Placebo comparator: Placebo (Core Study) - Participants received matching placebo tablets once a day (6 tablets of placebo).

Experimental: Perampanel (Extension Phase) - During the Extension Phase, participants previously assigned to perampanel arm (Core Study) continued taking study medication at the dose achieved at the end of the Core Study once daily. Participants previously assigned to a placebo arm (Core Study) started perampanel dose at 2 mg/day and up-titrated weekly in 2-mg increments up to a maximum dose of 12 mg/day.


Treatment: Drugs: Perampanel
2 mg titrated up to 8-12 mg maximum; taken once daily.

Treatment: Drugs: Placebo
Matching Placebo taken once daily.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 19 in Cognition Drug Research (CDR) System Global Cognition Score (Core Study)
Timepoint [1] 0 0
Baseline (Visit 2/Week 0 Evaluation) and Week 19 LOCF (last observation carried forward)
Secondary outcome [1] 0 0
Change From Baseline at Week 19 in the Power of Attention T-score in the Randomization Phase (Core Study)
Timepoint [1] 0 0
Baseline and Week 19
Secondary outcome [2] 0 0
Change From Baseline at Week 19 in the Continuity of Attention T-score in the Randomization Phase (Core Study)
Timepoint [2] 0 0
Baseline and Week 19
Secondary outcome [3] 0 0
Change From Baseline at Week 19 in the Quality of Episodic Secondary Memory T-score in the Randomization Phase (Core Study)
Timepoint [3] 0 0
Baseline and Week 19
Secondary outcome [4] 0 0
Change From Baseline at Week 19 in the Quality of Working Memory (Short Term) T-score in the Randomization Phase (Core Study)
Timepoint [4] 0 0
Baseline and Week 19
Secondary outcome [5] 0 0
Change From Baseline at Week 19 in the Speed of Memory T-score in the Randomization Phase (Core Study)
Timepoint [5] 0 0
Baseline and Week 19
Secondary outcome [6] 0 0
Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency (Core Study)
Timepoint [6] 0 0
From Baseline up to Week 19 LOCF
Secondary outcome [7] 0 0
Percent Change From Baseline in Seizure Frequency Per 28 Days During the Treatment Duration of the Randomization Phase (Core Study)
Timepoint [7] 0 0
Baseline and Week 19 LOCF
Secondary outcome [8] 0 0
Number of Participants Who Achieved Seizure-Free Status During the Maintenance Period and the Last 28 Days of the Maintenance Period During the Randomization Phase (Core Study)
Timepoint [8] 0 0
13 Week Maintenance Period
Secondary outcome [9] 0 0
Percent Change From Baseline in Seizure Frequency Per 28 Days Over the Perampanel Duration Exposure (Extension Phase)
Timepoint [9] 0 0
Week 1-13, Week 14-26, Week 27-39, and Week 40-52
Secondary outcome [10] 0 0
Percentage of Participants Who Experienced 50% or More Decrease in Seizure Frequency Over the Perampanel Duration Exposure (Extension Phase)
Timepoint [10] 0 0
Week 1-13, Week 14-26, Week 27-39, and Week 40-52
Secondary outcome [11] 0 0
Mean Change From Baseline to End of Treatment in Cognition Drug Research (CDR) System Global Cognition Score (Extension Phase)
Timepoint [11] 0 0
Baseline, Week 9, Week 19, Week, 30, Week 39, Week 52, and End of Treatment (defined as the last nonmissing value after date of first perampanel dose up to 14 days after date of last dose)
Secondary outcome [12] 0 0
Mean Change From Baseline in CDR System Global Cognition Score Over Time (Extension Phase)
Timepoint [12] 0 0
Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
Secondary outcome [13] 0 0
Mean Change From Baseline by Visits in CDR System Domain T-Scores (Extension Phase)
Timepoint [13] 0 0
Baseline, Week 9, Week 19, Week 30, Week 39, Week 52, and EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
Secondary outcome [14] 0 0
Mean Change From Baseline in CDR System Domain T-Score Over Time: Power of Attention (Extension Phase)
Timepoint [14] 0 0
Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52
Secondary outcome [15] 0 0
Mean Change From Baseline in CDR System Domain T-Score Over Time: Continuity of Attention (Extension Phase)
Timepoint [15] 0 0
Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
Secondary outcome [16] 0 0
Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Episodic Secondary Memory (Extension Phase)
Timepoint [16] 0 0
Baseline, Week 9, Week 19, Week 30, Week 39, and Week 52
Secondary outcome [17] 0 0
Mean Change From Baseline in CDR System Domain T-Score Over Time: Quality of Working Memory (Short Term) (Extension Phase)
Timepoint [17] 0 0
Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
Secondary outcome [18] 0 0
Mean Change From Baseline in CDR System Domain T-Score Over Time: Speed of Memory (Extension Phase)
Timepoint [18] 0 0
Baseline, Week 9, Week 19, Week, 30, Week 39, and Week 52
Secondary outcome [19] 0 0
Change From Baseline to End of Treatment in Controlled Oral Word Association Test Scores (COWAT) (Extension Phase)
Timepoint [19] 0 0
From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
Secondary outcome [20] 0 0
Change From Baseline to End of Treatment in Time to Complete Lafayette Grooved Pegboard Test (LGPT) (Extension Phase)
Timepoint [20] 0 0
From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
Secondary outcome [21] 0 0
Mean Change From Baseline in Bone Age Minus Age (Months) From Hand X-ray (Extension Phase)
Timepoint [21] 0 0
From Baseline up to Week 52 or up to EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)
Secondary outcome [22] 0 0
Change From Baseline to End of Treatment (EOT) for the Tanner Stage
Timepoint [22] 0 0
From Baseline up to Week 52 or EOT (defined as the last nonmissing value after date of first dose up to 14 days after date of last dose)

Eligibility
Key inclusion criteria
1. Considered reliable and willing to be available for the study duration and was able to record seizures and report adverse events (AEs) themselves or had a legal guardian or a caregiver who could record seizures and report AEs for them.
2. Understand the requirements of the Cognitive Drug Research (CDR) System tests and able to perform the tests appropriately at Visit 1.
3. Male or female, 12 to less than 18 years of age at the time of consent/assent
4. Had a diagnosis of epilepsy with partial-onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures (1981).
5. Diagnosis was established at least 6 months prior to Visit 1, by clinical history and an electroencephalogram (EEG) that was consistent with localization-related epilepsy; normal interictal EEGs were allowed provided that the subject met the other diagnosis criterion (ie, clinical history).
6. Had a brain imaging (e.g., magnetic resonance imaging [MRI] scan or computed tomography [CT]) within the 5 years prior to Visit 1 that ruled out a progressive cause of epilepsy.
7. Had at least 1 partial-onset seizure during the 4 weeks prior to Visit 1 despite a stable regimen of 1 to 3 concomitant antiepileptic drugs (AEDs).
8. Were currently being treated with stable doses of 1-3 AEDs. Only 1 inducer AED (either carbamazepine or phenytoin) out of the maximum of 3 AEDs was allowed.
9. Were on a stable dose of the same concomitant AED(s) for at least 4 weeks prior to Visit 1; in the case where a new AED regimen was initiated for a subject, the dose must have been stable for at least 8 weeks prior to Visit 1.
10. Female subjects of childbearing potential must had a negative serum human chorionic gonadotropin (beta-hCG) at Visit 1 and a negative urine pregnancy test prior to randomization at Visit 2. Female subjects of period of at least 60 days following administration of the last dose of study medication to commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method [condom + spermicide, condom + diaphragm with spermicide]). Abstinence was considered an acceptable method of contraception on a case by case basis upon prior approval by the Medical Monitor.
11. Had an intelligence quotient (IQ) of greater than or equal to 70, using the Kaufman Brief Intelligence Test, second edition (KBIT-2).
12. Provided written informed consent signed by the legal guardian and a written assent from the subject prior to entering the study or undergoing any study procedures.

Extension Phase:

Had completed all scheduled visits up to and including Visit 8 in the Core Study Randomization Phase.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Had a diagnosis of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies.
2. Had current or a history of pseudo-seizures (psychogenic non-epileptic seizures [PNES]) within approximately 5 years prior to Visit 1.
3. Had a diagnosis of Lennox-Gastaut syndrome.
4. Had seizure clusters where individual seizures could not be counted.
5. Had a history of status epilepticus that required hospitalization during the 12 months prior to the Visit 1.
6. Had an unstable psychiatric diagnosis that could confound the investigator's ability to conduct the study or that could prevent completion of the protocol specified tests (e.g., significant suicide risk, including suicidal behavior and ideation 6 months prior to Visit 1, current psychotic disorder, or acute mania).
7. Had any concomitant illnesses/co-morbidities (e.g., autism, attention deficit hyperactivity disorder [ADHD]) at Visit 1 that could severely affect cognitive function during the course of the study.
8. Had previously participated in a clinical trial involving perampanel.
9. Had chronically or routinely use benzodiazepines and who have not discontinued the use at least 4 weeks prior to Visit 1.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
133
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Belgium
State/province [9] 0 0
Bruxelles
Country [10] 0 0
Belgium
State/province [10] 0 0
Leuven
Country [11] 0 0
Belgium
State/province [11] 0 0
Ottignies
Country [12] 0 0
Czechia
State/province [12] 0 0
Ostrava
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Debrecen
Country [15] 0 0
Hungary
State/province [15] 0 0
Miskolc
Country [16] 0 0
India
State/province [16] 0 0
Bangalore
Country [17] 0 0
India
State/province [17] 0 0
Hyderabad
Country [18] 0 0
India
State/province [18] 0 0
Mangalore
Country [19] 0 0
India
State/province [19] 0 0
Nagpur
Country [20] 0 0
India
State/province [20] 0 0
New Delhi
Country [21] 0 0
India
State/province [21] 0 0
Pune
Country [22] 0 0
India
State/province [22] 0 0
Secunderabad
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Daegu
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Latvia
State/province [25] 0 0
Daugavpils
Country [26] 0 0
Latvia
State/province [26] 0 0
Riga
Country [27] 0 0
Latvia
State/province [27] 0 0
Valmiera
Country [28] 0 0
Poland
State/province [28] 0 0
Gdansk
Country [29] 0 0
Poland
State/province [29] 0 0
Poznan
Country [30] 0 0
Spain
State/province [30] 0 0
Comunidad Valenciana
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid, Communidad De
Country [32] 0 0
Thailand
State/province [32] 0 0
Bangkok
Country [33] 0 0
Thailand
State/province [33] 0 0
Mueang Nonthaburi

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
Haichen Yang, M.D., M.A.
Address 0 0
Study Director
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/NCT01161524