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The purpose of this study is to compare EpiCeptâ„¢ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amitriptyline 4% ketamine 2% cream, placebo capsules | Active Comparator | Np-1 cream and placebo gabapentin |
|
| gabapentin capsules, placebo cream | Active Comparator | gabapentin caps and placebo cream |
|
| placebo cream and capsules | Placebo Comparator | placebo cream and capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCept-NP-1 Cream | Drug | ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 28 days |
| 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. | baseline to 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert H Dworkin, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Centers | New Delhi | 110016 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Gabapentin Capsules, Placebo Cream | oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily |
| FG002 | Placebo Cream and Capsules | placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Gabapentin Capsules, Placebo Cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach. | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | EpiCept Corporation | 914-606-3500 | sallard@epicept.com |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Gabapentin Capsules | Drug | 1800mg/day capsules for 4 weeks |
|
|
| placebo | Drug | placebo cream and caps |
|
|
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
| BG002 | Placebo Cream and Capsules | placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Gabapentin Capsules, Placebo Cream | oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily |
| OG002 | Placebo Cream and Capsules | placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily |
|
|
|
| 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. | Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline to 28 Days |
|
|
|
|
| 0 |
| 140 |
| 7 |
| 140 |
| EG001 | Gabapentin Capsules, Placebo Cream | oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily | 0 | 144 | 2 | 144 |
| EG002 | Placebo Cream and Capsules | placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily | 0 | 76 | 1 | 76 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70. |