Efficacy and Safety Study of BIIB074 in Participants With Small Fiber Neuropathy

  • STATUS
    Recruiting
  • End date
    Jun 2, 2022
  • participants needed
    186
  • sponsor
    Biogen
Updated on 12 May 2021
Investigator
Biogen
Primary Contact
Research Site (0.0 mi away) Contact
+148 other location
diabetes
insulin
diabetes mellitus
nephropathy
hemoglobin a1c
glycosylated hemoglobin
retinopathy
diabetic retinopathy
hypoglycemic agents
oral hypoglycemic

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.

Details
Condition Diabetes Mellitus, Peripheral Neuropathy, Diabetes Prevention, Diabetes Mellitus Types I and II, Small Fiber Neuropathy, Diabetes (Pediatric), Small Fibre Neuropathy, diabetes mellitus (dm)
Treatment Placebo, BIIB074
Clinical Study IdentifierNCT03339336
SponsorBiogen
Last Modified on12 May 2021

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