Diabetic Peripheral Neuropathy, Neuralgia
Conditions
Keywords
DPN, Diabetic, Nerve Pain
Brief summary
This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.
Detailed description
This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).
Interventions
DRUGEpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
topical cream applied daily for 4 weeks
DRUGplacebo cream
inactive placebo cream applied two times daily
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 chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of \> 4 during the baseline week.
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 in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | baseline and 4 weeks treatment | diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Cream vehicle cream applied twice daily for 4 weeks | 112 |
| Amitriptyline 4% Ketamine 2% Cream active topical cream applied twice daily for 4 weeks | 114 |
| Total | 226 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Amitriptyline 4% Ketamine 2% Cream | Placebo Cream | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 26 Participants | 46 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 86 Participants | 180 Participants |
| Age Continuous | 56.06 years STANDARD_DEVIATION 9.35 | 55.05 years STANDARD_DEVIATION 11.044 | 55.56 years STANDARD_DEVIATION 10.214 |
| Region of Enrollment India | 114 participants | 112 participants | 226 participants |
| Sex: Female, Male Female | 49 Participants | 55 Participants | 104 Participants |
| Sex: Female, Male Male | 65 Participants | 57 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 112 | 17 / 114 |
| serious Total, serious adverse events | 0 / 112 | 0 / 114 |
Outcome results
Primary
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.
Time frame: baseline and 4 weeks treatment
Population: ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo Cream | Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | 1.64 units on a scale |
| Amitriptyline 4% Ketamine 2% Cream | Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | 2.12 units on a scale |
p-value: 0.083ANCOVA