Clinical Trial Results:
An Open-label Extension Phase of the Double-blind, Placebo-controlled, Dose-escalation, Parallel-group Study of E2007 (perampanel) as an Adjunctive Therapy in Patients With Refractory Partial Seizures
Summary
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EudraCT number |
2005-004293-24 |
Trial protocol |
SE LT DE CZ GB ES LV BE FI EE FR NL |
Global end of trial date |
01 Jul 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Mar 2016
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First version publication date |
26 Mar 2016
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
E2007-A001-207
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00368472 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Eisai Inc.
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Sponsor organisation address |
155 Tice Boulevard Woodcliff Lake, New Jersey, United States, 07677
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Public contact |
Medical Information, Eisai Europe limited, +44 845676 1400, LMedInfo@eisai.net
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Scientific contact |
Medical Information, Eisai Europe limited, +44 845676 1400, LMedInfo@eisai.net
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
08 Aug 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jul 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective for this study was to evaluate the safety and tolerability of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures with or without secondary generalization that completed the E2007-A001-206 or the E2007-G000-208 study.
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Protection of trial subjects |
This study was conducted in accordance with standard operating procedures (SOPs) of the sponsor (or designee), which are designed to ensure adherence to Good Clinical Practice (GCP) guidelines as required by the following:
- Principles of the World Medical Association Declaration of Helsinki (World Medical Association, 2008)
- International Conference on Harmonisation (ICH) E6 Guideline for GCP (CPMP/ICH/135/95) of the European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products, International Conference on Harmonisation of Pharmaceuticals for Human Use
- Title 21 of the United States (US) Code of Federal Regulations (US 21 CFR) regarding clinical studies, including Part 50 and Part 56 concerning informed subject consent and Institutional Review Board (IRB) regulations and applicable sections of US 21 CFR Part 312
- European Good Clinical Practice Directive 2005/28/EC and Clinical Trial Directive 2001/20/EC for studies conducted within any European Union (EU) country. All suspected unexpected serious adverse reactions were reported, as required, to the Competent Authorities of all involved EU member states.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
10 Oct 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
Sweden: 3
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Country: Number of subjects enrolled |
United Kingdom: 1
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Country: Number of subjects enrolled |
Belgium: 7
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Country: Number of subjects enrolled |
Czech Republic: 24
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Country: Number of subjects enrolled |
Estonia: 4
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Country: Number of subjects enrolled |
Finland: 2
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Country: Number of subjects enrolled |
France: 7
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Country: Number of subjects enrolled |
Germany: 7
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Country: Number of subjects enrolled |
Latvia: 2
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Country: Number of subjects enrolled |
Lithuania: 29
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Country: Number of subjects enrolled |
Australia: 9
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Country: Number of subjects enrolled |
United States: 40
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Country: Number of subjects enrolled |
Netherlands: 2
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Worldwide total number of subjects |
138
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EEA total number of subjects |
89
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
136
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 138 subjects provided informed consent and were enrolled in this study. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||||||
Arms
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Arm title
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Perampanel | ||||||||||||||||||||||||
Arm description |
Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Perampanel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Perampanel 2 mg to 12 mg, once daily.
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Baseline characteristics reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study. |
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End point title |
Number of Participants With Treatment-emergent Non-serious Adverse Events (AEs) and Treatment-emergent Serious (SAEs) [1] | ||||||||||
End point description |
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered an
investigational product. A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was as a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). In this study, treatment emergent AEs (defined as an AE (serious or non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed. The details are presented in the safety section of the result.
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End point type |
Primary
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End point timeframe |
From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Descriptive analyses were performed based on the study group and the study drug administered for this outcome. |
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Notes [2] - All participants who received at least 1 dose of study drug and were evaluable for this endpoint. |
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No statistical analyses for this end point |
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End point title |
Percent Change in Seizure Frequency Per 28 Days Relative to Pre-Perampanel Baseline | ||||||||
End point description |
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The seizure frequency per 28 days was calculated as the number of seizures divided by the number of days in the interval and multiplied by 28. The percent change in 28-day seizure frequency from baseline was assessed for all partial-onset seizures types. For participants who had been assigned to treatment with perampanel (previous treatment), preperampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel.
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 221
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Notes [3] - All participants who received ≥ 1 dose of study drug and had valid seizure data during OLE study. |
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No statistical analyses for this end point |
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End point title |
Percentage of Participants Who Experienced a 50% or Greater Reduction in Seizure Frequency Per 28 Days Relative to the Pre-perampanel Baseline | ||||||||
End point description |
Seizure frequency was derived from information (seizure count and type) recorded in participant diary. The percentage
of participants who experienced a 50% or greater reduction in seizure frequency per 28 days relative to the preperampanel
Baseline (responders) was assessed. For participants who had been assigned to treatment with perampanel (previous treatment), pre-perampanel Baseline referred to the Prerandomization Phase of the Core Double Blind study. For participants who had been assigned to treatment with placebo (previous treatment), pre-perampanel Baseline was computed from all data during the Core Double Blind study (including Prerandomization Phase) prior to treatment with perampanel. The data is presented as percent responders.
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End point type |
Secondary
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End point timeframe |
Baseline up to week 221
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Notes [4] - All participants who received ≥ 1 dose of study drug and had valid seizure data during OLE study. |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
From date of first dose of perampanel up to 30 days after the last dose of perampanel or up to approximately 8 years.
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Adverse event reporting additional description |
Treatment emergent adverse events (TEAEs) (defined as an adverse event that started/increased in severity
on/after the first dose of study medication up to 30 days after the final dose of study medication) were
assessed.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Perampanel
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Reporting group description |
Subjects previously receiving perampanel/placebo in the double blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the OLE study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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13 Oct 2005 |
Protocol amendment #1 dated 13 Oct 2005:
• Site number was increased from 30 to 50 sites to meet planned enrollment numbers.
• Language was added to address the addition of European and North American sites and the deletion of US sites to this study in “Contact Details.
• Language was added to clarify that Week 52 assessments should be performed at Week 52 or if patient prematurely terminates from the study.
• Miscellaneous changes such as added European contact information for shipment of laboratory samples; ESL personnel contact information; EudraCT number; IND number; and clarification that patients with clinically significant laboratory abnormalities may be discontinued from the study at the investigator’s discretion.
• The International System of Units (SI) equivalent was added to the WBC and absolute neutrophil values
• The controlled room temperature was revised to meet European standards.
• Laboratory assessments were revised.
• Revised current version of Declaration of Helsinki with the 1996 version.
• Administrative changes, correction of minor spelling and typographical errors. |
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07 Jun 2006 |
Protocol amendment #2 dated 07-JUN-2006
• The title was changed to reflect the extended study timeframe.
• Administrative changes that do not impact the scientific meaning of the trial.
• Twice a day (BID) dosing may not be necessary and was removed as an option in protocol.
• Once a day (QD) vs BID efficacy comparison was removed as a secondary objective.
• Determination of E2007 levels was removed as a secondary objective in protocol since ample PK data was collected from core Phase II and III studies.
• The duration of the Titration Phase was reduced to 6 weeks. The Maintenance Phase was increased to allow patients to receive E2007 at the highest tolerated dose for 52 weeks.
• Additional sites were added to increase enrollment.
• Revisions to protocol for clarification purpose.
• Revisions to inclusion and exclusion criteria.
• Revisions in the test assessments to maintain consistency across all sites globally and to clarify the procedures.
• Anti-epileptic drugs (AED) sampling was removed as it was not necessary to the main purpose of this study.
• Clinical and Patient Global Impressions of change scales were removed.
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19 Nov 2006 |
Protocol amendment #3 dated 19-NOV-2006
• Incorporate recent preclinical findings of in vitro phototoxicity into the safety information.
• Clarified that the study drug would be taken at bedtime based on current tolerability data.
• Clarified timing for enrollment from the double-blind study into the open-label study.
• Revised criterion for excluding patients with ECG abnormalities to be uniform for males and females.
• Updated SAE Reporting section with contract research organization (CRO) information (previously unavailable), and with updated SAE text concerning follow-up.
• Revised Visit 5 window to adjust for drug packaging.
• Inhibitors of CYP3A4/5 not excluded.
• Editorial, formatting, and typo corrections.
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15 Feb 2007 |
Protocol amendment #4 dated 15-FEB-2007
• Incorporation of patients from E2007-G000-208 (Phase IIb, double blind, placebo controlled, maximum tolerated dose (MTD) trial, 48 patients, up to 12mg/day E2007) into E2007-G000-207 (open label extension) so that there is one extension study for both E2007-A001-206 (double blind, placebo-controlled, Phase II, proof-of-concept (PoC) epilepsy trial, 153 randomized, up to 4mg/day E2007) and E2007-G000-208 patients.
• Allow the former E2007-A001-206 patients a chance to access higher doses (up to 12mg/dayE2007) if up to 4mg/day E2007 (original OLE) is insufficient in controlling seizures (at least 3 partial seizures per month on average) during the maintenance phase of the open label extension study (E2007-A001-207).
• Harmonize remaining aspects of E2007-A001-206 and E2007-G000-208
• Miscellaneous changes such as clarifications to protocol sections; revise formulation and packaging; revise contact information; revise the AED and non AED dosing plan to allow flexibility; updated SAE reporting information to clarify hospitalization; and editorial and formatting changes.
• Revise rationale for dose selection based on data PK data for concomitant use of CYP3A-inducing AEDs and/or non-CYP3A-inducing AEDs. |
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04 Jun 2007 |
Protocol amendment #5 dated 04-JUN-2007
• Updated phototoxicity / photoallergy results from in vivo studies.
• Extended the open label extension phase to an additional 3 years to monitor long-term safety of E2007 given as adjunctive, long-term treatment in patients with refractory partial onset seizures.
• Administrative changes, miscellaneous editorial/format changes.
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08 Jun 2009 |
Protocol amendment #6 dated 08 June 2009, v2.0
• Study title was revised to remove the study duration from the title to avoid the need for additional amendments should the study duration be extended in the future
• Change in sponsor name and address from Eisai Medical Research, Inc. to Eisai Inc.,
• Clarify that tolerability is also a component of the primary objective
• Study design, treatment, synopsis, rational, duration, Physical and Neurological Examination, vital signs, etc. was revised to consolidate the text for consistency and clarity (ie, subjects from the preceding double-blind studies are treated similarly except where noted) and to remove redundancy throughout the protocol
• Revised protocol deviation/violation text for consistency with other ongoing perampanel studies.
• To clarify that 1 mg tablets are no longer permitted for dispensing in the study and that all subjects on an
odd dose (eg, 1, 3, 5 mg) should be titrated to an even dose (eg, 2, 4, 6 mg).
• To update the number of concomitant AEDs allowed (as subject may now discontinue all concomitant AEDs).
• To revise the list of prohibited medications.
• Miscellaneous changes such as change assessment times specified from Weeks to Visits, provide the abbreviation for lactate dehydrogenase, corrected for consistency of terminology throughout protocol, clarify durations (all text references to months have been converted to weeks eg, 1 month = 4 weeks), update SAE reporting fax and phone numbers according to the reassignment of CRO responsibilities, etc.
• To clarify the instructions in regard to early terminations and the Sponsor’s position on the need for down titrations upon early termination.
• To update the protocol with Eisai’s current standard Pregnancy reporting text.
• To generalize text to ensure consistency in instructions with study drug labeling and Investigator’s Brochure. |
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08 Jul 2010 |
Protocol amendment 7 v1.0 dated 08-Jul-2010
• Secondary objective, study procedures, efficacy assessments, statistics was revised to evaluate the long term maintenance of E2007 efficacy to the last efficacy collecting visit of the E2007-A001-207 study as dispensing, collection, and review of seizure diaries will no longer be required, as sufficient and more standardized data for efficacy has been collected in the Phase 3 program for perampanel.
• Extension of study duration for an additional 216 weeks for a total duration of approximately 8 years. Revised relevant protocol sections to implement this change.
• Orthostatic vitals will no longer be required (only standard sitting vitals), as the current information on the
• Revise safety profile of perampanel to indicate that only standard sitting vitals need be collected.
• Miscellaneous changes such as update status of studies E2007-A001-206 and E2007-A001-208.
• Added information on the instructions regarding study drug compliance when phone visits.
• To allow flexibility in the timing of electrocardiograms (ECGs) in relation to blood draws. |
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26 Jun 2012 |
Protocol amendment 8 dated 26 June 2012
• Corrected Eisai US Address.
• The perampanel Phase 3 program in partial onset seizures (POS) has been completed, and Regulatory submissions to seek approval for marketing have been made to several countries. Therefore, Study E2007-A001-207 will be closed and the protocol was revised to schedule the EOT visit.
• Miscellaneous changes such as update abbreviation table.
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11 Feb 2013 |
Protocol amendment 9 dated 11 Feb 2013
• Revised definition of study end in the United States- Upon implementation of Amendment 08, the sponsor will be closing the study protocol. The study will end after European Union (EU) Marketing Authorization Application (MAA) approval (EU countries) and after United States (US) launch (US). However, if it is the opinion of the treating physician that the patient would benefit significantly from further treatment with perampanel after the trial concludes, then it is Eisai’s intent to make perampanel available under Eisai’s compassionate use policy (available upon request) and according to local country legislative provision. Perampanel treatment via local country legislative provision will be available until the time perampanel is commercially available in the country in which the patient resides. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
Results were ready but could not be released before 21 July 2015 due to EudraCT System issues. |