Clinical trial NCT00612105: Safety/Efficacy Study of Retigabine vs. Placebo in Post-Herpetic Neuralgia (PHN)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of-Concept Study to Evaluate the Efficacy of Maximally Tolerated Doses of Retigabine vs. Placebo in Reducing the Pain Associated With Post-Herpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Keywords: Postherpetic Neuralgia, PHN, Shingles,
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: This is a Phase 2a proof of concept study evaluating the safety/efficacy of retigabine vs. placebo in patients with post-herpetic neuralgia. After screening, patients will enter a maximum 6 week titration period followed by a 4 week maintenance period and a 3 week taper phase.

Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent
* 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:

* 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

Primary outcomes:
measure: Primary Endpoint Will be the Change From Baseline in Average Pain Score Over the Last 7 Days of the Maintenance Phase.
timeFrame: Baseline and Week 4 (Maintenance Phase-MP)
Secondary outcomes:
measure: Change From Baseline to Weeks 2 and 4 of the Maintenance Phase in Mean In-clinic Pain Assessment
timeFrame: Baseline and Weeks 2 and 4 (Maintenance Phase - MP)
measure: Number of Rescue Medication Tablets Taken Per Day During the Maintenance Phase (MP)
timeFrame: Weeks 1, 2, 3, and 4 Maintenance Phase
measure: Change From Baseline in Pain Intensity Score at Each Week During the Maintenance Phase (MP)
timeFrame: Baseline and Weeks 1, 2, 3, and 4 (MP)
measure: Number of Participants Classified as Responders, With a 50% and 30% Pain Reduction From Baseline to the Last 7 Days of the Maintenance Phase
timeFrame: Baseline and Week 4 Maintenance Phase (MP)
measure: 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
timeFrame: Baseline and End of Maintenance Phase (MP) (Week 4).
measure: 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 Sleep Quantity
timeFrame: Baseline and End of Maintenance Phase (MP) (Week 4).
measure: Number of Participants With the Indicated Change From Baseline to the End of the Maintenance Phase in Optimal Sleep Based on the Sleep Quantity Domain of the MOS Sleep Scale
timeFrame: Baseline and End of Maintenance Phase (MP) (Week 4).
measure: Number of Participants With the Indicated Overall Patient Global Impression of Change (PGIC)
timeFrame: Baseline to the end of Maintenance Phase (MP) (Week 4)
measure: Mean Score on the Treatment Satisfaction Questionnaire for Medication (TSQM) at the End of the Maintenance Phase
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Scores on the Brief Pain Inventory-Short Form (BPI-SF) at the End of the MP for All Participants Who Completed Week-4 of the MP and Who Terminated Early During the MP
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Scores on the Medical Outcomes Short Form-36 (SF-36) at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Scores for Reported Health Transition at the End of the MP for All Participants Who Completed Week 4 of the MP and Who Terminated Early During the MP
timeFrame: End of maintenance Phase (MP) (Week 4)
measure: Number of Participants With the Indicated Responses at Baseline to the Question: "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Tactile Allodynia
timeFrame: Baseline Phase (Day -7 to Randomization Day 0)
measure: Number of Participants With the Indicated Responses at Baseline to the Questions of "Is it Cool?" and "Is it Painful?" in an Assessment of Cold Threshold and Allodynia
timeFrame: Timeframe: Baseline Phase (Day -7 to Randomization Day 0)
measure: Number of Subjects With the Indicated Responses at Baseline to the Questions: "How Sharp Was the Affected Side Compared to the Opposite Side?" and "How Painfule Was the Affected Side Compared to the Opposite Side?" in an Assessment of Hyperalgesia
timeFrame: Baseline Phase (Day -7 to Randomization Day 0)
measure: Number of Participants With the Indicated Responses at the End of the MP to the Question: "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Tactile Allodynia
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Number of Participants With the Indicated Responses at the End of the MP to the Questions of "Is it Cool?" and "Is it Painful?" in an Assessment of Cold Threshold and Allodynia
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Number of Participants With Indicated Responses at the End of the MP to the Questions: "How Sharp Was the Affected Side Compared to the Opposite Side?" and "How Painful Was the Affected Side Compared to the Opposite Side?" in an Assessment of Hyperalgesia
timeFrame: End of Maintenance Phase (MP) (Week 4)
measure: Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Irritable Nociceptors"
timeFrame: Baseline and Week 4 Maintenance Phase (MP)
measure: Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype"Deafferentation Type 1 (D Type 1)"
timeFrame: Baseline and Week 4 Maintenance Phase (MP)
measure: Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Deafferentation Type 2 (D Type 2)"
timeFrame: Baseline and Week 4 Maintenance phase (MP)
measure: Change From Baseline in the Average Diary Pain Score to the Last 7 Days of the Maintenance Phase by Post Herpetic Neuralgia (PHN) Subtype "Unclassifiable"
timeFrame: Baseline and Week 4 Maintenance Phase (MP)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Evansville
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Bay City
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Hattiesburg
country: United States
state: Mississippi
city: Saint Louis
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Toms River
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Tabor City
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Cleveland
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Allentown
country: United States
state: Pennsylvania
city: Bridgeville
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Little River
country: United States
state: South Carolina
city: North Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Sugar Land
country: United States
state: Texas
city: Midvale
country: United States
state: Utah
city: Port Elizabeth
country: South Africa
state: Eastern Cape
city: Bloemfontein
country: South Africa
state: Free State
city: Belville
country: South Africa
state: Western Cape
city: George
country: South Africa
state: Western Cape
Study officials:
affiliation: Sponsor GmbH
name: David Lineberry
role: STUDY_DIRECTOR
References: