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.
This is a double-blind, placebo-controlled crossover study, randomized, crossover study of ABX-1431 HCl as add-on therapy in the treatment of central neuropathic pain.The efficacy of ABX-1431 will also be assessed by the change in pain intensity scores using a numerical rating scale (NRS-11). All patients will undergo a screening visit for enrollment criteria. Eligible patients will be treated with daily medication for 7 to 9 weeks, which will include some treatment with placebo and some treatment with ABX-1431 HCl. Patients will use a web based application to record their daily average pain using a numerical rating scale (NRS-11). This study will enroll up to 32 patients with chronic central pain due to one of the four following diagnostic groups: Neuromyeliltis Optica Spectrum Disorder (NMOSD), longitudinally extensive transverse myelitis (LETM), Multiple Sclerosis (MS), and Transverse Myelitis (TM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
ABX-1431 HCl, capsules, 20 mg
Matching placebo
The Walton Centre
Liverpool, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Change in mean pain score between ABX-1431 HCl and placebo based on the Pain NRS-11 ordinal numeric rating scale
The treatment difference of ABX-1431 HCl versus placebo is estimated from the change from baseline in daily NRS-11 Pain to the final 7 days of treatment in each two-week treatment period. Baseline levels of pain or taken from the final 7 days of treatment in the period preceding each double-blind treatment period.
Time frame: placebo, treatment (14 days)
Short Form Brief Pain Inventory (SF-BPI) Scores
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
Patient Global Impression of Change (PGIC) score
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
Proportion of patients achieving and maintaining >30%, >50%, reduction in mean pain intensity score compared to baseline and cumulative proportion of responders' analysis
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
Actigraphically estimated parameters of sleep (WASO, TST, sleep efficiency, average overnight activity counts) and general activity measured by percentage of sedentary time, and moderate to high intensity activity
Difference in the change from baseline between ABX-1431 HCl and placebo
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Time frame: placebo, treatment (14 days)
Sleep interference (NRS-11) A NRS-11 scale recording sleep interference due to transverse myelitis pain / central pain in the previous week (in which 0 = no interference and 10 = greatest possible interference)
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
ABX-11431 and metabolite M55 plasma PK
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)
2-AG hydrolysis in PBMC
Difference in the change from baseline between ABX-1431 HCl and placebo
Time frame: placebo, treatment (14 days)