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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
14
Topical application to painful area
Topical application to painful area
Akademiska sjukhuset
Uppsala, Sweden
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.
Time frame: Change from baseline to Day 7
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.
Time frame: Baseline and day 7 of the respective treatment period
Intensity of spontaneous pain on a numerical rating scale (NRS)
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.
Time frame: 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.
Time frame: Day 7 of the respective treatment period
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