Phase 1
N=35
The Efficacy of MK-8291 in Participants With Post-herpetic Neuralgia (PHN) With Allodynia (MK-8291-012)
Postherpetic Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT02336555 ↗Enrolled (actual)
35
Serious AEs
1.5%
Results posted
Dec 2019
Primary outcome: Primary: Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period — -1.776; -1.263 Score on a scale — p=0.075
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-8291 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Intensity at Week 4 of Each Treatment Period |
-1.776; -1.263 | 0.075 |
| SECONDARY Percentage of Participants Achieving a 30 Percent or Greater Change From Baseline to Day 28 in Pain Intensity |
36.7; 34.4 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02336555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.