Effect of NRD135S.E1 in Peripheral Neuropathic Pain in Diabetic Patients

NCT02345291 | Completed Phase 2

• 1 other identifier: NRD135S.E1-201
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 10

Brief Summary

A multicenter, Phase 2a, randomized, double-blind, placebo (vehicle)-controlled, parallel-group, dose-finding study designed to evaluate the efficacy, safety and tolerability of NRD135S.E1 in adult patients with diabetes mellitus type 1 or 2 with neuropathic pain. Potential study patients will sign informed consent prior to undergoing any study-related procedure.

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• • Change from the baseline week to Week 3 in the weekly average daily pain intensity as measured on an 11-point numerical pain scale (NPS)

  three weeks

Secondary Outcomes (7)

• Change from the baseline week to Week 3 in the weekly maximum daily pain intensity as measured on the NPS

  three weeks

• Change from the baseline week to Week 3 in the weekly consumption of rescue analgesic (i.e., number of paracetamol 500 mg tablets taken per week)

  three weeks

• • Change from Day 8 (end of baseline week) to Day 29 (24 h after last study drug administration) in Short-Form McGill Pain Questionnaire (SF-MPQ) score

  three

• Clinician's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)

  three weeks

• Patient's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)

  three weeks

Study Arms (4)

NRD135S.E1 A

EXPERIMENTAL

A = 10 mg NRD135S.E1 once daily PO for 21 days

Drug: NRD135S.E1

NRD135S.E1 B

EXPERIMENTAL

B = 40 mg NRD135S.E1 once daily PO for 21 days

Drug: NRD135S.E1

NRD135S.E1 C

EXPERIMENTAL

C = 150 mg NRD135S.E1 once daily PO for 21 days

Drug: NRD135S.E1

Placebo to match NRD135S.E1 D

PLACEBO COMPARATOR

D = Placebo once daily PO for 21 days

Drug: Placebo to match NRD135S.E1

Interventions

NRD135S.E1 DRUG

A small chemical entity for treatment of neuropathic pain NRD135S.E1

Also known as: E1

NRD135S.E1 A; NRD135S.E1 B; NRD135S.E1 C

Placebo to match NRD135S.E1 DRUG

Placebo capsule to match NRD135S.E1 capsules

Also known as: Placebo for E1

Placebo to match NRD135S.E1 D

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males agree to use condoms throughout treatment and follow up study periods.
• Females must not be of childbearing potential as evidenced by at least one of the following:
• ≥ 62 years old and amenorrheic for ≥ 1 year
• Amenorrheic ≥ 12 consecutive months and a documented serum follicle stimulating hormone (FSH) level \> 35 mIU/mL
• Irregular menstrual periods and a documented FSH level \> 35 mIU/mL
• On hormone replacement therapy and prior clinical evidence of menopause based on any of the criteria above
• Surgically sterile
• Known stable diabetes mellitus for the last 3 months. (No oral hypoglycemic medications change allowed. Maximum insulin change allowed is ± 20%).
• Evidence of peripheral neuropathy associated with diabetes mellitus diagnosed by DN4 criteria.
• Presence of ongoing pain due to DPN for at least 3 months.
• Mean DPN pain intensity of 4 to 9 on the NPS at screening.
• HbA1c ≤ 9% of total hemoglobin at screening.
• Willing to stop pain medications for DPN (except for limited use of paracetamol).
• Signed written informed consent.
• Subjects must have signed and dated an Institutional Review Board / Independent Ethics Committee approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.

You may not qualify if:

• Female of childbearing potential.
• Neurologic disorders unrelated to DPN that may interfere with the assessment of DPN.
• Known allergy or intolerance to paracetamol.
• Evidence of non-DPN polyneuropathy.
• The presence of severe pain associated with conditions other than DPN (e.g., peripheral vascular disease, phantom pain, etc.) that could confound the self-evaluation of pain due to DPN.
• Any anti-epileptic or anti-depressive treatment. Amityptiline (Elatrol/Elatrolet) or duloxetine (Cymbalta) are permitted at screening but not later.
• Constant use of non-steroidal anti-inflammatory drugs or opiates that cannot be withdrawn during the washout period and the whole study duration.
• Participation in another clinical trial in the last 3 months.
• Poor compliance with prescribed medication or alcohol or drug abuse within 2 years before screening.
• Hypersensitivity to paracetamol or any of the inactive ingredients in NRD135S.E1 capsules.
• Any serious medical condition, including the presence of laboratory abnormalities, that places the patient at an unacceptable risk if he or she participates in this study or confounds the ability to interpret data from the study.
• Patients with any hematological disorder.
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
• Patients whose judgment has been impaired by their physical ir mental condition

Sponsors & Collaborators

• Novaremed Ltd.: lead

Study Sites (10)

Diabetes and Endocrinology clinic, Bat-Yamon Medical center, Clalit health services

Bat Yam, Israel

Location

Diabetes clinic, Lin Medical Center

Haifa, 35152, Israel

Location

Rambam Medical Center, Diabetic Endocrine unit

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Diabetic and Endocrinology clinic, Clalit health services

Jerusalem, 9310609, Israel

Location

Meir Medical Center, Endocrynology, diabetes and metabolism Unit

Kfar Saba, 44821, Israel

Location

Ziv Medical Center, Endocrinology Unit

Safed, Israel

Location

Diabetes Department Migdal Hamea Clalit health services

Tel Aviv, 62038, Israel

Location

DMC Medical Center

Tel Aviv, 6937947, Israel

Location

Sorasky Medical Center, Diabetic unit

Tel Aviv, Israel

Location

MeSH Terms

Interventions

methyl N-acetylsibirosaminide

Study Officials

• Eli Kaplan, MD

  Novaremed Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 26, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 22, 2016

Record last verified: 2016-07

Locations

IL (10)