The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy
The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
420
Nerve Conduction Studies
Time frame: Day 1, Week 24
Nerve fiber density
Time frame: Day 1, Week 24
QST
Time frame: Day 1, Week 12, Week 24
Symptom
Time frame: Day 1, Week 12, Week 24
Clinical Global Impression
Time frame: Week 12, Week 24
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80mg, once daily for 24 weeks