Central Pain Study for ABX-1431 (NCT03138421) | Clinical Trial Compass
CompletedPhase 1
Central Pain Study for ABX-1431
United Kingdom9 participantsStarted 2017-08-01
Plain-language summary
This study will determine the safety and tolerability of ABX-1431 in patients with central pain when added on to background pain therapy.
During the course of this study, each participant will take a daily dose of 20 mg of ABX-1431 or a matching placebo for approximately 7 to 9 weeks.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with chronic central pain, present for at least 3 months due to one of the four following diagnostic groups: NMOSD, LETM, MS, or TM.
* Patient has a diagnosis of NMOSD with anti-AQP4 IgG or without AQP4-IgG as defined by the International Panel for NMO Diagnosis at least 3 months prior to the screening visit (IPND 2015)
* Patients with idiopathic, LETM, comprising an intramedullary MRI lesion or continuous segments of spinal cord atrophy with a clinical history consistent with acute myelitis, and with chronic pain syndrome consistent with the lesion neuroanatomy may be enrolled. These LETM patients must also demonstrate evidence of acute, inflammatory myelopathy in the past (e.g. clinically acute symptomatic myelitis plus inflammatory CSF analysis (e.g. elevated WBC and IgG index) or imaging consistent with inflammatory myelopathy). LETM must be diagnosed at least 3 months prior to the screening visit.
* Patient with MS defined by McDonald criteria \[1\] or Poser criteria \[2\] at least 3 months prior to screening visit.
* Patients with post-infectious, autoimmune or idiopathic TM diagnosed by a neurologist at least 6 months prior to the screening visit.
* Patient's chronic pain must be neuropathic in nature, and anatomically plausible based on underlying neuropathology. If patient has an additional source of pain (e.g., vascular ischemic pain, transient spasm associated pain, headache, chronic lower back pain or concomitant osteoarthr…
What they're measuring
1
Change in mean pain score between ABX-1431 HCl and placebo based on the Pain NRS-11 ordinal numeric rating scale