Nerve Pain, Neuropathy, PHN, Post Herpetic Neuralgia
Conditions
Keywords
Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain, Topical
Brief summary
The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)
Detailed description
This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.
Interventions
DRUGEpiCept-NP-1 Cream
ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
DRUGGabapentin Capsules
1800mg/day capsules for 4 weeks
DRUGplacebo
placebo cream and caps
Sponsors
EpiCept Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash
Exclusion criteria
* Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. | baseline and 28 days | Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain. |
| Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | baseline to 28 Days | Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily | 140 |
| Gabapentin Capsules, Placebo Cream oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily | 144 |
| Placebo Cream and Capsules placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily | 76 |
| Total | 360 |
Baseline characteristics
| Characteristic | Gabapentin Capsules, Placebo Cream | Placebo Cream and Capsules | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 21 Participants | 34 Participants | 90 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 55 Participants | 106 Participants | 270 Participants |
| Age Continuous | 53.2 years STANDARD_DEVIATION 15.53 | 53.2 years STANDARD_DEVIATION 16.47 | 51.3 years STANDARD_DEVIATION 16.04 | 52.5 years STANDARD_DEVIATION 15.91 |
| Region of Enrollment India | 144 participants | 76 participants | 140 participants | 360 participants |
| Sex: Female, Male Female | 49 Participants | 30 Participants | 56 Participants | 135 Participants |
| Sex: Female, Male Male | 95 Participants | 46 Participants | 84 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 140 | 2 / 144 | 1 / 76 |
| serious Total, serious adverse events | 0 / 140 | 0 / 144 | 0 / 76 |
Outcome results
Primary
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Time frame: baseline to 28 Days
Population: Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | 2.424 units on a scale |
| Gabapentin Capsules, Placebo Cream | Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | 2.471 units on a scale |
| Placebo Cream and Capsules | Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | 1.877 units on a scale |
Comparison: the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.p-value: 0.840990% CI: [-0.33, 0.43]ANCOVA
Primary
Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.
Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Time frame: baseline and 28 days
Population: This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. | 2.424 units on a scale |
| Gabapentin Capsules, Placebo Cream | Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. | 2.471 units on a scale |
| Placebo Cream and Capsules | Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. | 1.877 units on a scale |
Comparison: In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.p-value: 0.044195% CI: [0.01, 1.08]ANOVA