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This is a double-blind, randomized, placebo-controlled crossover outpatient study in patients with peripheral neuropathic pain with allodynia or hyperalgesia to cold, heat, brush and/ or pinprick stimulation. Patients will in random order receive ACD440 Gel or placebo treatment twice daily for 7 days, topically applied to the painful area. This is followed by a 2-week washout period, then receive the alternate treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACD440 Gel 14mg/g | Experimental | Topically applied to painful neuropathic area twice daily for 7 days |
|
| Placebo Gel | Placebo Comparator | Topically applied to painful neuropathic area twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACD440 Gel 14mg/g | Drug | Topical application to painful area |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stimulus evoked pain | Pain evoked by stimulus: brushing pain, pressure pain or cold pain, subitems 8-10 of the Neuropathic Pain Symptom Inventory (NPSI). Intensity is scored on a scale from 0-10, where 0 means no pain and 10 means worst pain possible. | Change from baseline to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of neuropathic pain | Intensity of symptoms of neuropathic pain assessed by the Neuropathic Pain Symptom Inventory (NPSI). The NPSI total score ranges from 0 to 50, where 0 depicts absence of pain and 50 is the worst score. | Baseline and day 7 of the respective treatment period |
| Intensity of spontaneous pain on a numerical rating scale (NRS) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of Treatment-Emergent Adverse Events as assessed by spontaneous reporting and by laboratory measures and electrocardiogram (ECG) | From enrollment through study completion on Day 42. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akademiska sjukhuset | Uppsala | 75185 | Sweden |
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| Placebo Gel |
| Drug |
Topical application to painful area |
|
Spontaneous pain intensity during the last 24-hours, rated on a Numerical Rating Scale (NRS), where score range from 0-10, where 0 means no pain and 10 means worst pain possible. |
| Baseline and day 7 of the respective treatment period |
| Patient Global Impression of Change (PGIC) | Rating on a 7-step verbal scale: much worse - worse - a little worse - no difference - a little better - better - much better. | Day 7 of the respective treatment period |