Painful Diabetic Peripheral NeuropathyPhase 2NCT03176472
Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing ricolinostat in people with Painful Diabetic Peripheral Neuropathy, run by Regenacy Pharmaceuticals LLC at 35 sites in United States.
Trial summary
This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- ricolinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 282 participants
- Where
- 35 sitesUnited States
- Study dates
- 7 Dec 2020to 28 Apr 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetes of at least 6 months with optimized and stable glycemic control during the 3 months prior to Screening
- Painful distal symmetric sensorimotor polyneuropathy due to diabetes
- Douleur Neuropathique 4 (DN4) score of ≥4
- Satisfactory diary data during the 14-day Pain Observation period determined by an algorithm that includes diary compliance, overall level of pain and day-to-day variability in pain
Who cannot join
- Pregnant or lactating
- Body Mass Index (BMI) >40 kg/m2
- Presence of any neuropathy other than DPN and/or significant risk factors for neuropathy other than diabetes
- Other pain conditions that could confound the results of this study, or other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
- Painful DPN patients who have undergone lower limb amputations, are non-ambulatory, or whose walking is so impaired as to require a walker or other assistance for ambulation
- Have met Diagnostic and Statistical Manual of Mental Disorders V (DSM V) criteria for opioid use disorder or alcohol use disorder
Show all 15Show fewer
- Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month prior to Screening
- Suicidal ideation/behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- The use of marijuana or cannabidiol (CBD) during the 30 days prior to starting study drug
- Chronic use of over-the-counter capsaicin on extremities within 3 months of Screening and/or prescription Qutenza use within 6 months of Screening
- Corrected QT interval at Screening using QTcF of ≥450 msec (male) or ≥460 msec (female)
- Hemoglobin < 11.5 g/dL (female) or < 13 g/dL (male), total white blood cell count < 2500/mm3, neutrophil count < 1250/mm3, lymphocyte count < 1000/mm3, or platelet count < 100,000/mm3
- HIV positive and/or active hepatitis virus (A, B, or C) infection
- Current or previous (≤1 month of Screening) enrollment in a clinical trial involving treatment with an investigational product
- Any known recent exposure within the 14 days prior to initial Screening to coronavirus disease 2019 (COVID-19) or symptoms of COVID-19 infection or other reason to suspect COVID-19 infection as assessed by the Investigator at the time of initial Screening
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Pinnacle Research Group LLC
Anniston, Alabama, 36207
FutureSearch Trials of Neurology
Austin, Texas, 78731
Hassman Research Institute
Berlin, New Jersey, 08009
NY Scientific
Brooklyn, New York, 11235
Innovative Research of West Florida Inc
Clearwater, Florida, 33756
MediSphere Medical Research Center, LLC
Evansville, Indiana, 47714
Triad Clinical Trials
Greensboro, North Carolina, 27410
Nerve and Muscle Center of Texas
Houston, Texas, 77030
Diabetes/Lipid Management & Research Center
Huntington Beach, California, 92648
National Research Institute
Huntington Park, California, 90255
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
DeLand Clinical Research Unit
Lake Mary, Florida, 32746
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123
Physicians Research Associates, LLC
Lawrenceville, Georgia, 30046
Torrance Clinical Research Institute Inc
Lomita, California, 90717
ClinCloud LLC
Maitland, Florida, 32751
Tandem Clinical Research
Marrero, Louisiana, 70072
APF Research LLC
Miami, Florida, 33134
International Research Associates LLC
Miami, Florida, 33183
Coastal Carolina Research Center
North Charleston, South Carolina, 29405
Providence Clinical Research
North Hollywood, California, 91606
Sensible Healthcare LLC
Ocoee, Florida, 34761
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
Arizona Research Center
Phoenix, Arizona, 85053
Progressive Medical Research
Port Orange, Florida, 32127
Wasatch Clinical Research LLC
Salt Lake City, Utah, 84107
Sun Research Institute
San Antonio, Texas, 78215
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Center for Clinical Research Inc
San Francisco, California, 94115
Palmetto Clinical Research
Summerville, South Carolina, 29485
Meridien Research
Tampa, Florida, 33634
Diablo Clinical Research Inc
Walnut Creek, California, 94598
Metabolic Research Institute Inc
West Palm Beach, Florida, 33401
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.
Read the detailed description
The study includes an approximately 12 week randomized, double-blind, placebo controlled Treatment period in which patients will receive either ricolinostat or placebo, followed by an approximately 12 week open label Safety Extension period during which all patients will receive ricolinostat 120 mg daily.
Prior to randomization, patients will be enrolled in a baseline Pain Observation period from Day -14 to Day -1, during which the NRS (average and worst pain) will be recorded daily using an electronic daily diary that will be completed by patients to allow patients to familiarize themselves with the pain rating procedures, and to establish a baseline and confirm eligibility to participate. Patients will also initiate daily dosing during this time to evaluate compliance eligibility for participation. A daily diary will be used by the patient to record the pain assessments and rescue medication use. A follow-up phone contact will be conducted at Day -7 to Day -5 to review diary and dosing compliance.
Following the baseline Pain Observation period, patients who meet entry criteria will be randomized in a 1:1 ratio to receive either ricolinostat or placebo. During the 12-week double-blind, placebo-controlled Treatment period, patients will return for assessments in accordance with the schedule of assessments. At the conclusion of the approximately 12 week open label Safety Extension period, patients will enter a Follow-up safety washout and assessment period, which will incorporate 2 visits at approximately 2 and 4 weeks following the final Safety Extension visit, with assessments performed as outlined in the schedule of assessments.
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Being tested
- ricolinostat, Placebo
- Keywords
- Diabetic Neuropathic Pain, Neuropathic Pain, HDAC6, ricolinostat, Painful Diabetic Peripheral Neuropathy, DPN
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ricolinostatDrug
Also called ACY-1215
120 mg per dose in 12 mL liquid formulation
PlaceboDrug
12 mL liquid formulation placebo
| Study group | Role | What they receive |
|---|---|---|
| ricolinostat | Experimental | Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL) Receives: Drug: ricolinostat |
| placebo | Placebo comparator | Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Average Pain Intensity (NRS)
Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.
Measured: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]
Secondary outcomes (1)
Change in Non-pain Neuropathic Signs (UENS)
Change in non-pain neuropathic signs utilizing the Utah Early Neuropathy Score (UENS) which is a physical examination-based scale designed to assess early sensory predominant polyneuropathy. Compared with other scales, the UENS emphasizes severity and spatial distribution of pin (sharp) sensation loss in the foot and leg and focuses less on motor weakness. The UENS utilizes a numeric scale from 0-42, with higher scores indicating greater disease severity.
Measured: Baseline week [Day-7 to Day 1] compared to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start7 Dec 2020
- Primary completion31 Oct 2022
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies 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
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenacy Pharmaceuticals LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176472
- Sponsor's protocol ID
- REGY-DN-201
- Status last verified
- Sep 2023
- First submitted
- 18 May 2017
- Last updated
- 21 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT03176472
- Acronym / sponsor ID
- REGY-DN-201
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Keywords
- Diabetic Neuropathic Pain, Neuropathic Pain, HDAC6, ricolinostat, Painful Diabetic Peripheral Neuropathy, DPN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Regenacy Pharmaceuticals LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Posted 21 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.
Detailed description
The study includes an approximately 12 week randomized, double-blind, placebo controlled Treatment period in which patients will receive either ricolinostat or placebo, followed by an approximately 12 week open label Safety Extension period during which all patients will receive ricolinostat 120 mg daily.
Prior to randomization, patients will be enrolled in a baseline Pain Observation period from Day -14 to Day -1, during which the NRS (average and worst pain) will be recorded daily using an electronic daily diary that will be completed by patients to allow patients to familiarize themselves with the pain rating procedures, and to establish a baseline and confirm eligibility to participate. Patients will also initiate daily dosing during this time to evaluate compliance eligibility for participation. A daily diary will be used by the patient to record the pain assessments and rescue medication use. A follow-up phone contact will be conducted at Day -7 to Day -5 to review diary and dosing compliance.
Following the baseline Pain Observation period, patients who meet entry criteria will be randomized in a 1:1 ratio to receive either ricolinostat or placebo. During the 12-week double-blind, placebo-controlled Treatment period, patients will return for assessments in accordance with the schedule of assessments. At the conclusion of the approximately 12 week open label Safety Extension period, patients will enter a Follow-up safety washout and assessment period, which will incorporate 2 visits at approximately 2 and 4 weeks following the final Safety Extension visit, with assessments performed as outlined in the schedule of assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
| Arm | Type | Receives |
|---|---|---|
| ricolinostat | Experimental | Drug: ricolinostatRicolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL) |
| placebo | Placebo comparator | Drug: PlaceboPlacebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetes of at least 6 months with optimized and stable glycemic control during the 3 months prior to Screening
- Painful distal symmetric sensorimotor polyneuropathy due to diabetes
- Douleur Neuropathique 4 (DN4) score of ≥4
- Satisfactory diary data during the 14-day Pain Observation period determined by an algorithm that includes diary compliance, overall level of pain and day-to-day variability in pain
Key exclusion criteria (15 listed)
- Pregnant or lactating
- Body Mass Index (BMI) >40 kg/m2
- Presence of any neuropathy other than DPN and/or significant risk factors for neuropathy other than diabetes
- Other pain conditions that could confound the results of this study, or other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
- Painful DPN patients who have undergone lower limb amputations, are non-ambulatory, or whose walking is so impaired as to require a walker or other assistance for ambulation
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 |
|---|---|---|
| ricolinostatAlso: ACY-1215120 mg per dose in 12 mL liquid formulation | Drug | ricolinostat |
| Placebo12 mL liquid formulation placebo | Drug | placebo |
Primary outcome
Change in Mean Average Pain Intensity (NRS)
Time frame: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks]
Difference between mean average pain intensity using the 11-point numerical pain rating scale (NRS) consisting of pain measurement from 0-10 with 10 being the worst pain and 0 being no pain at all.
1 secondary outcome
Change in Non-pain Neuropathic Signs (UENS)
Time frame: Baseline week [Day-7 to Day 1] compared to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
35 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 ricolinostat in people with Painful Diabetic Peripheral Neuropathy, run by Regenacy Pharmaceuticals LLC at 35 sites in United States.
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 4 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Mean Average Pain Intensity (NRS) (time frame: Baseline week [Day-7 to Day 1] compared to Final week [12 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 21 Sep 2023.