Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN)
This study has been completed.
Sponsor:
Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00592904
First received: January 3, 2008
Last updated: February 6, 2013
Last verified: February 2013
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| Tracking Information | |||||
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| First Received Date ICMJE | January 3, 2008 | ||||
| Last Updated Date | February 6, 2013 | ||||
| Start Date ICMJE | January 2008 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
Efficacy of perampanel treatment in PDN and PHN patients will be assessed with the SF-MPQ as the primary outcome measure. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] | ||||
| Change History | Complete list of historical versions of study NCT00592904 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
PGIC, SF-36, and rate of study discontinuation due to lack of efficacy. Safety: AEs, laboratory assessments, vital signs, physical examinations and 12-lead ECGs, prior and concomitant medications and tolerability of perampanel. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluating E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN) | ||||
| Official Title ICMJE | A Multi-Center, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 (Perampanel) in Patients With Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN) | ||||
| Brief Summary | The purpose of this study is to evaluate the safety, tolerability and continued efficacy of perampanel in patients previously enrolled in double-blind, placebo-controlled studies for Painful Diabetic Neuropathy (PDN) or Post-Herpetic Neuralgia (PHN). |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neuralgia | ||||
| Intervention ICMJE | Drug: E2007
Perampanel doses will be up-titrated in 2 mg steps at minimum weekly intervals starting at 2 mg daily and up-titrated to 12 mg daily (taken orally).
Other Name: Perampanel |
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| Study Arm (s) | Experimental: 1
Intervention: Drug: E2007 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 262 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | November 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Each patient must meet all of the following criteria to be enrolled in this study:
Exclusion Criteria: Patients who meet the following criterion will be excluded from this study:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00592904 | ||||
| Other Study ID Numbers ICMJE | E2007-G000-228 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Eisai Inc. | ||||
| Study Sponsor ICMJE | Eisai Inc. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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