Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy
Status:
Terminated
Trial end date:
2021-04-12
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to evaluate the efficacy of BIIB074 in treating pain
experienced by participants with confirmed small fiber neuropathy (SFN) that is idiopathic or
associated with diabetes mellitus. A secondary endpoint that relates to the primary objective
is the change from Randomization to Week 12 of the double-blind period in mean average daily
pain score.
The secondary objectives of this study are to evaluate the effect on worst pain, neuropathic
pain quality, sleep interference due to pain, patient global impression, use of rescue
medication, and SFN symptoms in participants treated with BIIB074; to investigate the safety
and tolerability of BIIB074 in participants with SFN; and to characterize the
pharmacokinetics (PK) of BIIB074 in participants with SFN.