E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Painful Diabetic Neuropathy (Painful Herpetic Neuralgia will not be studied in the EU as the preceding double-blind study was not conducted here) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012680 |
E.1.2 | Term | Diabetic neuropathy |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate long-term (1-year) safety while administering perampanel to patients with PDN or PHN. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate continued efficacy, or persistence and durability of effect, of perampanel treatment for patients with PDN or PHN. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each patient must meet all of the following criteria to be enrolled in this study:
1. Have completed the EOT Visit of study E2007-A001-218 or study E2007-G000-227 no more than 12 weeks prior to Baseline (Visit 1) for the OLE study. The eligibility status of patients who do not enroll during this 12 week period will be evaluated on a case by case basis via discussion between the Investigator and the Sponsor. (revised per Amendment 01) 2. Female patients should be either of nonchildbearing potential as a result of surgery or menopause (1 year after onset), or of childbearing potential who agree to continue practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) throughout the entire study period and for 2 months after their last dose of study drug. (revised per Amendment 01). Female patients using hormonal contraceptives must also be using an additional approved method of contraception (eg, a barrier method plus spermicide or IUD) throughout the study. All female patients must also have a negative pregnancy test at Baseline (Visit 1). (revised per Amendment 01) 3. Have provided written informed consent prior to entering the study and prior to undergoing any study-related procedures. 4. Be reliable, willing, and able to cooperate with the study procedures.
|
|
E.4 | Principal exclusion criteria |
Patients who meet the following criterion will be excluded from this study:
1. Those who at Baseline (Visit 1) have a clinically significant finding(s) that could make them unsuitable for the study in the opinion of the Investigator or sponsor. (revised per Amendment 01) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary Safety Endpoint(s) Tabulations and summaries of the following parameters will be presented overall to evaluate the safety of perampanel: TEAEs, laboratory assessments, vital signs, physical examinations, and ECGs. Additional data will be collected on prior and concomitant medications and extent of exposure to study drug.
Adverse Events The number and percentage of patients reporting TEAEs will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) preferred term. Incidence tables will be constructed and listings of patients with SAEs and AEs leading to discontinuation will be displayed.
Clinical Laboratory Assessments Changes in laboratory data from Baseline (Visit 1) to each visit week will be summarized both numerically and graphically. The incidence of treatment-emergent abnormal laboratory values (TEAVs) will be summarized using pre-defined criteria for clinically significant abnormal laboratory values. The incidence of new or worsening clinically significant findings from Baseline (Visit 1) to endpoint in laboratory values (laboratory shift tables) for categorical variables will be tabulated.
Orthostatic Vital Signs Changes in vital signs from Baseline (Visit 1) to each visit will be summarized both numerically and graphically.
Physical Examinations Complete physical examination findings at baseline and at the study endpoint will be summarized.
Electrocardiograms Changes from Baseline (Visit 1) to the last available visit for the 12-lead ECG results will be calculated from the incidence of new or worsening clinically significant findings (treatment-emergent ECG measures).
Prior and Concomitant Medications The number and percentage of patients using medications other than the study drug within 30 days prior to or during the course of the study will be tabulated.
Extent of Exposure Study compliance (%) and the extent of exposure to the study drug will be summarized for each patient enrolled. Extent of exposure will measure the exposure time for the OLE study and will not include exposure from the preceding double-blind study.
Primary Efficacy Endpoint The primary efficacy assessment for this study is the SF-MPQ. The change in SF-MPQ scores from Baseline to study endpoint and the change in SF-MPQ scores to other study visits will be summarized. In addition, maintenance of perampanel treatment effect, or persistence and durability of effect, will be assessed with summaries over time. For patients who were on active treatment in the preceding double-blind PDN or PHN study, change in SF-MPQ scores from Baseline will be determined using baseline assessments taken before randomization in the double-blind studies; for patients who were on placebo during the preceding double-blind studies, change in SF-MPQ scores from Baseline will be determined using assessments taken at Baseline (Visit 1) of this study. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |