The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Postherpetic Neuralgia

Treatments: Drug: MK-8291; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02336555

8291-012

2014-002396-28 (EudraCT Number)

MK-8291-012 (Other Identifier)

Details and patient eligibility

About

This study aims to determine whether MK-8291 is effective in reducing pain in participants with post-herpetic neuralgia (PHN) with allodynia.

The primary hypothesis is that when compared to placebo, treatment with MK-8291 reduces the change from Baseline in participant-reported pain intensity by 1 on an 11-point numeric rating scale.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non-pregnant female (and/or partner) agrees to use two acceptable methods of birth control throughout the trial until 2 weeks after the last dose of treatment
• female is postmenopausal or surgically sterile
• has a clinical diagnosis of PHN with allodynia for at least 3 months duration after healing of rash
• has a body mass index (BMI) =< 35 kg/m^2, inclusive
• is in good health, with exception of PHN
• is on a stable dose for at least 30 days prior to screening if taking any of the following: opioids, non-opioids, paracetomol, non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, antidepressants
• is a nonsmoker or has not used nicotine or nicotine containing products for at least prior 3 months

Exclusion criteria

• has a non-PHN chronic pain state
• has a history of clinically significant and inadequately treated endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
• has a history of malignant cancer
• has a history or presence of esophagitis
• has a history of significant multiple and/or severe allergies (e.g. food, drug, latex), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food
• is positive for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
• had major surgery, donated or lost approximately 500 mL of blood within 4 weeks prior to screening
• has participated in another investigational trial within 4 weeks prior to screening
• has a history of risk factors for Torsades de Pointes, has hypokalemia or hypomagnesemia
• has a history or presence of clinically significant cardiac arrhythmia, taking substances with the target of reducing heart rate and or exercising endurance sports
• has had an injection of local anesthetics or steroids in the region affected by PHN, within 35 days prior to randomization
• anticipates using prescription and non-prescription drugs or herbal remedies during trial
• consumes excessive amounts of alcoholic or caffeinated beverages
• uses cannabis, any illicit drugs, or has a history of drug (including alcohol) abuse within 12 months of screening visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

MK-8291 → Placebo

Experimental group

Description:

In Treatment Period 1, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)

Treatment:

Drug: MK-8291

Drug: Placebo

Placebo → MK-8291

Experimental group

Description:

In Treatment Period 1, participants were orally administered Placebo once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. After Treatment Period 1, participants were to undergo a minimum of a 7-day Washout Period, which was followed by Treatment Period 2. In Treatment Period 2, participants were orally administered 10 mg MK-8291 once daily on Days 1 and 2, twice daily on Days 3 to 27, and once daily on Day 28 of the period. (Total duration of treatment: up to approximately 63 days)

Treatment:

Drug: MK-8291

Drug: Placebo