Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)

NCT00612105 | Completed Phase 2 Results

• 1 other identifier: VRX-RET-E22-NP201
• Study Type: interventional
• Target: 187
• Locations: 2 countries
• Sites: 45

Brief Summary

The purpose of the study is to evaluate the efficacy of retigabine vs. placebo in reducing pain associated with post-herpetic neuralgia.

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic Neuralgia, PHN, Shingles,

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.

  Change from Baseline (BL) was calculated as the value of the average diary pain score for the last 7 days of the MP minus the value of the average pain score at BL (post wash-out period, including the average of the last 7 available entries prior to/including the diary pain measurement on Titration Day 0). Based on their pain experienced during the previous 24 hours, participants assessed their pain every evening at bedtime in an electronic diary by choosing the appropriate number on an 11-point Numerical Rating Scale (NRS): 0, no pain; 1 to 3, mild; 4 to 6, moderate; 7 to 10, severe pain.

  Baseline and Week 4 (Maintenance Phase-MP)

Secondary Outcomes (22)

• Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment

  Baseline and Weeks 2 and 4 (Maintenance Phase - MP)

• Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)

  Weeks 1, 2, 3, and 4 Maintenance Phase

• Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)

  Baseline and Weeks 1, 2, 3, and 4 (MP)

• Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase

  Baseline and Week 4 Maintenance Phase (MP)

• Change From Baseline to the End of the MP (Included All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP) in Medical Outcomes Study (MOS) Sleep Scale Scores

  Baseline and End of Maintenance Phase (MP) (Week 4).

Study Arms (2)

1

EXPERIMENTAL

Retigabine

Drug: Retigabine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Retigabine DRUG

150mg/day up to 900mg/day

1

Placebo DRUG

daily

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• Male or female subjects
• 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

You may not qualify if:

• Other significant pain that may potentially confound PHN pain assessment
• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (45)

Unknown Facility

Birmingham, Alabama, 35215, United States

Location

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Mesa, Arizona, 85210, United States

Location

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Tucson, Arizona, 85741, United States

Location

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Little Rock, Arkansas, 72205, United States

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Garden Grove, California, 92845, United States

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La Jolla, California, 92037, United States

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San Diego, California, 92128, United States

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Westlake Village, California, 91361, United States

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Orlando, Florida, 32806, United States

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Sarasota, Florida, 34243, United States

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Tampa, Florida, 33613, United States

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West Palm Beach, Florida, 33407, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30309, United States

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Evansville, Indiana, 47714, United States

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Overland Park, Kansas, 66211, United States

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Lexington, Kentucky, 40503, United States

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Shreveport, Louisiana, 71103, United States

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Bay City, Michigan, 48706, United States

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Detroit, Michigan, 48201, United States

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Hattiesburg, Mississippi, 39401, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Toms River, New Jersey, 8755, United States

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New York, New York, 10004, United States

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Raleigh, North Carolina, 27607, United States

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Tabor City, North Carolina, 28463, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Cleveland, Ohio, 44195, United States

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Mogadore, Ohio, 44260, United States

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Allentown, Pennsylvania, 18103, United States

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Bridgeville, Pennsylvania, 15017, United States

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Charleston, South Carolina, 29412, United States

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Little River, South Carolina, 29566, United States

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North Myrtle Beach, South Carolina, 29582, United States

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Nashville, Tennessee, 37215, United States

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Austin, Texas, 78756, United States

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San Antonio, Texas, 78229, United States

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Sugar Land, Texas, 77479, United States

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Midvale, Utah, 84047-1761, United States

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Bloemfontein, Free State, 9300, South Africa

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Belville, Western Cape, 7530, South Africa

Location

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George, Western Cape, 6529, South Africa

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Herpes Zoster

Interventions

ezogabine

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Associate Director Clinical Operations
• Organization: Valeant Pharmaceuticals International, Inc.

david.lineberry@valeant.com

919-294-3080

Study Officials

• David Lineberry

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 8, 2018
• Results First Posted: January 11, 2012

Record last verified: 2018-04

Locations

US (41); ZA (4)