Study of DA-9801 to Treat Diabetic Neuropathy

NCT01822925 | Completed Phase 2 Results DMC

• 1 other identifier: DA9801-DN-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 14

Brief Summary

To evaluate the effectiveness of DA-9801 at 300mg, 600mg, 900mg and placebo, in reducing pain in subjects with diabetic neuropathic pain compared to their baseline values.

Conditions

Diabetic Neuropathy

Keywords

Diabetes; Pain; Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in Clinic Visit Pain Score at the 12 Week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)

  Pain score was assessed by the subject using the 11-point Likert rating scale for pain (0=no pain to 10=worst possible pain) prior to conduct of any other study assessment. The change in clinic visit pain score at the 12-week visit was compared to baseline.

  Baseline to 12 weeks of treatment

Secondary Outcomes (10)

• Percentage Change in Clinic Visit Pain Score at the 12-week Visit Compared to Baseline as Assessed by the 11-point Likert Numerical Rating Scale (NRS)

  Baseline and over 12 week treatment period

• Number of Participants With at Least 30% Improvement Compared to Baseline as Assessed by the 11- Point Likert Numerical Rating Scale (NRS) at the Week 12 Clinic Visit

  Baseline to 12 week treatment period

• Difference in Average Weekly Pain Score Between Dose Groups as Assessed by Daily Diary

  Baseline to 12 week treatment period

• Difference in Average Weekly Most Severe Pain Score Between Dose Groups as Assessed by Daily Diary

  Baseline to 12 week treatment period

• Difference in Average Weekly Overnight Pain Score Between Dose Groups as Assessed by Daily Diary

  Baseline to 12 week treatment period

Study Arms (4)

DA-9801 300mg

EXPERIMENTAL

DA-9801 will be administered in tablet form, 100mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.

Drug: DA-9801 300mg

DA-9801 600mg

EXPERIMENTAL

DA-9801 will be administered in tablet form, 200 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.

Drug: DA-9801 600mg

DA-9801 900mg

EXPERIMENTAL

DA-9801 will be administered in tablet form, 300 mg taken 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.

Drug: DA-9801 900mg

Placebo

PLACEBO COMPARATOR

Placebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks.

Drug: Placebo

Interventions

DA-9801 300mg DRUG

300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks.

DA-9801 300mg

DA-9801 600mg DRUG

600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks.

DA-9801 600mg

DA-9801 900mg DRUG

900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks.

DA-9801 900mg

Placebo DRUG

Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18 to 75 years of age
• Diagnosed with Type I or Type II diabetes
• HbA1c ≤ 12% at the time of screening
• Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the lower extremities for more than 3 months prior to screening and with no adequate relief from other treatments
• Has an average pain score of ≥ 4 for 24 hours at least 4 days out of the week prior to randomization as assessed by the 11-point Likert NRS.
• If female of childbearing potential, subject must have a negative serum pregnancy test at screening
• Understands and is willing to participate in the clinical study and can comply with study procedures and visits.
• Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires
• Subject is willing and able to give informed consent

You may not qualify if:

• Evidence of another type of neuropathic pain caused by a condition other than diabetes
• Pain from another source as severe or greater than the pain under study
• BMI (Body Mass Index) \> 37 kg/m2
• Clinical signs of infection related to sores of any type on the legs
• Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
• Previous participation in the Treatment Phase of this Protocol
• History of drug or alcohol abuse, within the past 6 months
• Malignant disease not in remission for 5 years or more that has been medically or surgically treated without evidence of metastases
• Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subject's ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: c) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range; d) For laboratory results that are significantly lower than the normal range, specific criteria will be used to judge subject eligibility for randomization for Total protein, Albumin, and Hemoglobin or Platelets.
• Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
• New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest
• Pregnant or breast feeding
• Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
• d) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40mIU/m, OR; e) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, OR; f) Are using one or more of the following acceptable methods of contraception: surgical sterilization, hormonal contraception, and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
• Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation

Sponsors & Collaborators

• NeuroBo Pharmaceuticals Inc.: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (14)

Center for United Research, Inc.

Lakewood, California, 90712, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598-3347, United States

Location

Clinical Research Consulting, LLC

Milford, Connecticut, 06460, United States

Location

PAB Clinical Research

Brandon, Florida, 33511, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Novex Clinical Research, Inc.

New Bedford, Massachusetts, 02740, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

KRK Research

Dallas, Texas, 75230, United States

Location

North Texas Endocrine Center

Dallas, Texas, 75231, United States

Location

Houston Foot & Ankle Care

Houston, Texas, 77074, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Mellitus; Pain

Interventions

DA-9801

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President Clinical Operations
• Organization: NeuroBo Pharmaceuticals, Inc.

nikki.shannon@neurobopharma.com

617-313-7331

Study Officials

• Gabriel Maislos, D.P.M

  Houston Foot & Ankle Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Locations

US (14)