Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
NCT ID: NCT00612105
Last Updated: 2018-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2007-10-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Retigabine
Retigabine
150mg/day up to 900mg/day
2
Placebo
Placebo
daily
Interventions
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Retigabine
150mg/day up to 900mg/day
Placebo
daily
Eligibility Criteria
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Inclusion Criteria
* Male or female subjects
* 18-85 years of age
* PHN for more than 6 months after the healing of herpes zoster skin rash
* Has a pain score at screening and randomization that qualifies
Exclusion Criteria
* Previous neurolytic or neurosurgical therapy for PHN
* Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy
* Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation
* Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit
18 Years
85 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David Lineberry
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Garden Grove, California, United States
La Jolla, California, United States
San Diego, California, United States
Westlake Village, California, United States
Orlando, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Evansville, Indiana, United States
Overland Park, Kansas, United States
Lexington, Kentucky, United States
Shreveport, Louisiana, United States
Bay City, Michigan, United States
Detroit, Michigan, United States
Hattiesburg, Mississippi, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Toms River, New Jersey, United States
New York, New York, United States
Raleigh, North Carolina, United States
Tabor City, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Mogadore, Ohio, United States
Allentown, Pennsylvania, United States
Bridgeville, Pennsylvania, United States
Charleston, South Carolina, United States
Little River, South Carolina, United States
North Myrtle Beach, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Midvale, Utah, United States
Port Elizabeth, Eastern Cape, South Africa
Bloemfontein, Free State, South Africa
Belville, Western Cape, South Africa
George, Western Cape, South Africa
Countries
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Other Identifiers
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VRX-RET-E22-NP201
Identifier Type: -
Identifier Source: org_study_id
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