Efficacy and Safety of MEDI7352 in Subjects With Painful Diabetic Neuropathy

  • End date
    Aug 30, 2023
  • participants needed
  • sponsor
Updated on 20 January 2022
body mass index
chronic pain
administered intravenously
diabetic neuropathy
painful diabetic neuropathy


This is a study investigating the effect of MEDI7352 on chronic pain in patients with painful diabetic neuropathy.

The study incudes a screening period of up to 45 days and a 12-week treatment period during which MEDI7352 or placebo will be administered intravenously (IV) on 6 occasions, with each dose separated by 14 days. There will be a 6-week follow-up period.

Subjects will randomly be assigned to double-blind treatment with one of 4 dose levels of MEDI7352 or placebo

Condition Painful Diabetic Neuropathy
Treatment Placebo, MEDI7352
Clinical Study IdentifierNCT03755934
Last Modified on20 January 2022


Yes No Not Sure

Inclusion Criteria

Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
Body mass index of ≤42 kg/m2
Chronic PDN persistent for 6 months or longer, not adequately controlled by standard of care treatments
mean pain intensity score of ≥4, as measured on an 11-point (0-10) NRS
willing and able to discontinue all NSAID or COX-2 analgesic therapy
currently be taking medication for the treatment of PDN. Subjects should be taking at least one of the first-line medications (consistent with regional or local standard of care guidelines for PDN)

Exclusion Criteria

Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology that is considered to be distinct from that of PDN, and that is likely to interfere with assessment of peripheral nerve function, as judged by the investigator
History of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy
Diagnosis of clinically significant OA currently affecting a major joint in the upper extremity (shoulder, elbow, or wrist) or lower extremity (hip, knee, or ankle) or axial spine; or other degenerative disease affecting any joint in subjects for whom, in the opinion of the investigator, there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy
Chronic pain condition, other than PDN, that is likely to interfere with the evaluation of the subject's PDN pain, as judged by the investigator
Haemoglobin A1C greater than 8.5% (>8.5%)
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