Clinical Studies and Case Reports

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TitleThe MOBILE Study-A Phase IIa Enriched Enrollment Randomized Withdrawal Trial to Assess the Analgesic Efficacy and Safety of ASP8477, a Fatty Acid Amide Hydrolase Inhibitor, in Patients with Peripheral Neuropathic Pain.
Author(s)Bradford D et al.
Journal, Volume, IssuePain Med. ;18(12):2388-2400
Major outcome(s)A FAAH inhibitor did not reduce neuropathic pain
IndicationPainAbstract
MedicationOther cannabinoids

OBJECTIVE:
To evaluate the analgesic efficacy and safety of ASP8477 in patients with peripheral neuropathic pain (PNP).

DESIGN:
Enriched enrollment randomized withdrawal.

SETTING:
Centers in Poland (four), Czech Republic (six), and the United Kingdom (two).

SUBJECTS:
Patients aged 18 years or older with PNP resulting from painful diabetic peripheral neuropathy or postherpetic neuralgia.

METHODS:
A four-week screening period followed by a single-blind period (six-day dose titration and three-week maintenance period with ASP8477 [20/30 mg BID]). Treatment responders (defined as a ≥30% decrease in the mean average daily pain intensity during the last three days of the single-blind period) were stratified by disease and randomized to receive placebo or continue ASP8477 during a three-week, double-blind, randomized withdrawal period. The primary end point was change in mean 24-hour average numeric pain rating scale (NPRS) from baseline to end of double-blind period.

RESULTS:
Among 132 patients who enrolled, 116 entered the single-blind period and 63 (ASP8477, N = 31; placebo, N = 32) completed the double-blind period. There was no difference in mean 24-hour average NPRS score (P = 0.644) or in time-to-treatment failure (P = 0.485) between ASP8477 and placebo. During the single-blind period, 57.8% of patients were treatment responders. ASP8477 was well tolerated. During the single-blind period, 22% of patients experienced at least one treatment-related adverse event (TEAE); during the double-blind period, 8% in the ASP8477 arm and 18% in the placebo arm experienced at least one TEAE.

CONCLUSIONS:
ASP8477 was well tolerated in patients with PNP; however, ASP8477 did not demonstrate a significant treatment difference compared with placebo.

Route(s)
Dose(s)
Duration (days)
Participants
DesignControlled study
Type of publicationMedical journal
Address of author(s)
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