A phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of SKL1119 for the Pain of Diabetic Peripheral Neuropathy. Print E-mail

 Protocol# SKL11197C006

Protocol Title: A phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy, Safety and Tolerability of SKL1119 for the Pain of Diabetic Peripheral Neuropathy.

INCLUSION CRITERIA

  1. Male or female 18 years or older
  2. Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus, with a diagnosis at least 12 months prior to screening.
  3. At least Moderate pain, > or = 40mm on a 100mm VAS at the end of the washout phase ( in absent of any analgesic);
  4. Diabetes judged to be clinically stable for the past 3 months
  5. Subject in good general health with no concurrent illness that could cause or exacerbate the pain condition under study.
  6. HbA1c < or = 12 % at screening.
  7. Daily pain attributed to diabetic neuropathy for least 3months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
  8. Pain from  diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and bilateral.
  9. Subject may continue on non-analgesic medications are not on the list of the prohibited medication
  10. PROHIBITED MEDICATION :
    1. All thyroid supplement including, but not limited to Levothyroxine, Triiodothyronine and Dessicated thyroid
    2. Any medication that directly affect the thyroid gland
    3. CYP3A4 inducers:
      1. Carbamazepine
      2. Phenobarbital
      3. Phenytoin
  • (this med are prohibited from 30 day prior to screening to the last study visit)
  • ( the Investigator should contact the sponsor regarding any concomitant medication suspected of causing peripheral neuropathy or interfering with the perception of pain )
     11. Females must be of non- child bearing potential ( defined as either surgical sterile or at least one year postmenopausal, Menopause defined as 1 year since last menstrual period with associated subject sensations) or,
     12. If capable of bearing children, female must use a double-barrier method of contraceptive, or an intrauterine device.

Female capable of bearing children must  have negative serum pregnancy
(Beta –HCG) test at screening and negative urine pregnancy on Day1.

EXCLUSION CRITERIA:

  1. Pregnant or lactating female.
  2. Subject with BMI over 40.
  3. A marked baseline prolongation of QT/QTc interval  ( e.g., repeated demonstration of a QTc interval > 450 milliseconds (ms)).
  4. History of additional risk factors of TdP (e.g., heart failure, hypokalemia, family history of long QT syndrome).
  5. The use of concomitant medication that prolong the QT/ QTc interval.
  6. Have any serious or unstable disease of heart or blood vessels, liver, kidney, lung, or blood related illness.
  7. Pain due to peripheral vascular disease (e.g. intermittent claudication).
  8. Subject with known clinically significant decreased blood flow to the extremity.
  9. Subject cannot have pain from other sources that can confuse the assessment of the diabetic neuropathy pain.
  10. Subject requiring frequent use of short term analgesics, e.g., headaches
  11. Psychiatric condition that, in the opinion of the investigator, would affect subject   participation or be likely to lead to hospitalization during the course of the study.
  12. Subject with clinically significant hematologic or hepatic laboratory abnormality.
  13. Subject with positive result in HIV, hepatitis B or C antigens, or drug screening.
  14. Subject with a creatinine clearance of < 50ml/min.
  15. Has any active, or history of thyroid disease.
  16. Subject with active eye inflammation or infection.
  17. Any laboratory evidence of abnormal thyroid function.
  18. Are taking any medication to treat thyroid gland disease.
  19. Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
  20. Have profound autonomic dysfunction, or brittle diabetes;
  21. History of narcotic or alcohol abuse;
  22. Use of daily doses of opioid analgesics on regular basis, Except Tramadol and Tapentadol.
  23. Evidence of amputation (including toes), open ulcers, or Charcot joint.
  24. Cannot have failed more than two previous adequate therapeutic trials with approved treatment of pain of diabetic neuropathy.
  25. Subject currently receiving or who have received in the past, spinal stimulation, Intrathecal drug delivery, or IV lidocaine for the pain of diabetic neuropathy.
  26. Have used any investigator therapy within the last30 days, prior to beginning of the open-label phase.

 
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