A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study for the Pain of Diabetic Peripheral Neuropathy

Phase 2

Completed

Brief Summary: Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN).

Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy.

Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.

Detailed Description: This study is a double-blind, placebo controlled study with three phases;

1. a pre-study medication washout/screening phase upto 3 weeks

2. a 3-week, open label phase

3. a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.

Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.

Recruitment & Eligibility

Inclusion Criteria

18 years or older
Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
HbA1c < 12 % at Screening
Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.

Exclusion Criteria

Pregnant or lactating females
Subjects with BMI over 40
Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
Subjects with known clinically significant decreased blood flow to the extremities
Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
Have profound autonomic dysfunction, or brittle diabetes;
Evidence of amputations (including toes), open ulcers, or Charcot joint.

Arm && Interventions

Group	Intervention	Description
SKL11197	SKL11197	This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
Placebo	Placebo	This arm is the placebo comparator arm. Patients will be randomized to this arm.

Primary Outcome Measures

Name	Time	Method
Relief of diabetic neuropathy pain	24 hours

Secondary Outcome Measures

Name	Time	Method
Average daily pain score	24 hours

Locations (13): Nerve and Muscle Center of Texas
🇺🇸
Houston, Texas, United States
Comprehensive Clinical Development
🇺🇸
St. Petersburg, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸
Tampa, Florida, United States
Collaborative Neuroscience Network, Inc.
🇺🇸
Long Beach, California, United States
Neurological Research Institute
🇺🇸
Santa Monica, California, United States
Sunstone Medical Research, LLC
🇺🇸
Medford, Oregon, United States
Clinical Trials, Inc.
🇺🇸
Little Rock, Arkansas, United States
Neurology Clinic, P.C.
🇺🇸
Northport, Alabama, United States
Principals Research Group
🇺🇸
Hot Springs, Arkansas, United States
Renstar Medical Research
🇺🇸
Ocala, Florida, United States
Michigan Head Pain & Neurological Institute.
🇺🇸
Ann Arbor, Michigan, United States
International Clinical Research Institute
🇺🇸
Leawood, Kansas, United States
Creighton Diabetes Center
🇺🇸
Omaha, Nebraska, United States