Diabetic Peripheral Neuropathic PainPhase 2NCT02345291
Effect of NRD135S.E1 in Peripheral Neuropathic Pain in Diabetic Patients
A Phase 2 study testing NRD135S.E1 in people with Diabetic Peripheral Neuropathic Pain, run by Novaremed Ltd. at 10 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain
- What is being tested?
- NRD135S.E1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 10 sitesIsrael
- Study dates
- Apr 2015to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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
Show all 16Show fewer
- 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.
- Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Israel10 sites
Diabetes and Endocrinology clinic, Bat-Yamon Medical center, Clalit health services
Bat Yam
Diabetes clinic, Lin Medical Center
Haifa, 35152
Rambam Medical Center, Diabetic Endocrine unit
Haifa
Wolfson Medical Center
Holon
Diabetic and Endocrinology clinic, Clalit health services
Jerusalem, 9310609
Meir Medical Center, Endocrynology, diabetes and metabolism Unit
Kfar Saba, 44821
Ziv Medical Center, Endocrinology Unit
Safed
Diabetes Department Migdal Hamea Clalit health services
Tel Aviv, 62038
DMC Medical Center
Tel Aviv, 6937947
Sorasky Medical Center, Diabetic unit
Tel Aviv
About this study
Official title: A Phase 2a, Randomized, Double-blind, Placebo (Vehicle)-Controlled, Dose Finding Trial to Assess the Safety, Tolerability and Efficacy of NRD135S.E1 in Patients With Neuropathic Pain Associated With Diabetes Mellitus
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.
Read the detailed description
Following screening, eligible patients will be enrolled and go through a week of washout of analgesic treatment. Patients who are still eligible following the washout will be randomized to one of four treatment groups: NRD135S.E1 at 10, 40, or 150 mg per day or placebo (vehicle).
All four treatment groups will start study treatment with 1 week of single blind placebo (baseline week) followed by 3 weeks of the allocated double blind treatment (Weeks 1, 2, and 3). All patients will be followed for 30 days after the last study drug administration. The total study duration per patient is 9 to10 weeks.
Visit schedule: Screening (Days minus 14 to minus 8, Visit 1). Washout visit (Day minus 7, Visit 2). Randomization and start of placebo treatment (Day 1, Visit 3). Double blind treatment visits on Days 8 (Visit 4), 15 (Visit 5) and 29 (Visit 6). Follow up visit by telephone (Day 59, Visit 7).
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Being tested
- NRD135S.E1, Placebo to match NRD135S.E1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRD135S.E1Drug
Also called E1
A small chemical entity for treatment of neuropathic pain NRD135S.E1
Placebo to match NRD135S.E1Drug
Also called Placebo for E1
Placebo capsule to match NRD135S.E1 capsules
| Study group | Role | What they receive |
|---|---|---|
| NRD135S.E1 A | Experimental | A = 10 mg NRD135S.E1 once daily PO for 21 days Receives: Drug: NRD135S.E1 |
| NRD135S.E1 B | Experimental | B = 40 mg NRD135S.E1 once daily PO for 21 days Receives: Drug: NRD135S.E1 |
| NRD135S.E1 C | Experimental | C = 150 mg NRD135S.E1 once daily PO for 21 days Receives: Drug: NRD135S.E1 |
| Placebo to match NRD135S.E1 D | Placebo comparator | D = Placebo once daily PO for 21 days Receives: Drug: Placebo to match NRD135S.E1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: three
Clinician's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)
Measured: three weeks
Patient's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)
Measured: three weeks
Change from the baseline week to Week 3 in the weekly Daily Sleep Interference Score
Measured: three weeks
Incidence of treatment-emergent AEs (TEAEs)
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startApr 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novaremed Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eli Kaplan, MD, Study director, Novaremed Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345291
- Sponsor's protocol ID
- NRD135S.E1-201
- Status last verified
- Jul 2016
- First submitted
- 19 Jan 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Double-blind, Placebo (Vehicle)-Controlled, Dose Finding Trial to Assess the Safety, Tolerability and Efficacy of NRD135S.E1 in Patients With Neuropathic Pain Associated With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02345291
- Acronym / sponsor ID
- NRD135S.E1-201
- Conditions
- Diabetic Peripheral Neuropathic Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Novaremed Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following screening, eligible patients will be enrolled and go through a week of washout of analgesic treatment. Patients who are still eligible following the washout will be randomized to one of four treatment groups: NRD135S.E1 at 10, 40, or 150 mg per day or placebo (vehicle).
All four treatment groups will start study treatment with 1 week of single blind placebo (baseline week) followed by 3 weeks of the allocated double blind treatment (Weeks 1, 2, and 3). All patients will be followed for 30 days after the last study drug administration. The total study duration per patient is 9 to10 weeks.
Visit schedule: Screening (Days minus 14 to minus 8, Visit 1). Washout visit (Day minus 7, Visit 2). Randomization and start of placebo treatment (Day 1, Visit 3). Double blind treatment visits on Days 8 (Visit 4), 15 (Visit 5) and 29 (Visit 6). Follow up visit by telephone (Day 59, Visit 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NRD135S.E1 A | Experimental | Drug: NRD135S.E1A = 10 mg NRD135S.E1 once daily PO for 21 days |
| NRD135S.E1 B | Experimental | Drug: NRD135S.E1B = 40 mg NRD135S.E1 once daily PO for 21 days |
| NRD135S.E1 C | Experimental | Drug: NRD135S.E1C = 150 mg NRD135S.E1 once daily PO for 21 days |
| Placebo to match NRD135S.E1 D | Placebo comparator | Drug: Placebo to match NRD135S.E1D = Placebo once daily PO for 21 days |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- -Males agree to use condoms throughout treatment and follow up study periods.
- ≥ 62 years old and amenorrheic for ≥ 1 year
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRD135S.E1Also: E1A small chemical entity for treatment of neuropathic pain NRD135S.E1 | Drug | NRD135S.E1 A, NRD135S.E1 B, NRD135S.E1 C |
| Placebo to match NRD135S.E1Also: Placebo for E1Placebo capsule to match NRD135S.E1 capsules | Drug | Placebo to match NRD135S.E1 D |
Primary outcome
• 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)
Time frame: three weeks
7 secondary outcomes
Change from the baseline week to Week 3 in the weekly maximum daily pain intensity as measured on the NPS
Time frame: 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)
Time frame: 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
Time frame: three
Clinician's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)
Time frame: three weeks
Patient's Global Impression of Change from the baseline week at Day 29 (24 h after last study drug administration)
Time frame: three weeks
Change from the baseline week to Week 3 in the weekly Daily Sleep Interference Score
Time frame: three weeks
Incidence of treatment-emergent AEs (TEAEs)
Time frame: three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Peripheral Neuropathic Pain
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 2
Perineural Botulinum Toxin Injection Versus Oral Duloxetine in Relief of Foot Pain in Painful Peripheral Diabetic Neuropathy
Diabetic Peripheral Neuropathy, Painful Diabetic Neuropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Kaplan, MD study director
Novaremed Ltd.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NRD135S.E1 in people with Diabetic Peripheral Neuropathic Pain, run by Novaremed Ltd. at 10 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• 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) (time frame: three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.