Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03176472|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Painful Diabetic Peripheral Neuropathy||Drug: ricolinostat Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||274 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy|
|Actual Study Start Date :||December 7, 2020|
|Estimated Primary Completion Date :||December 30, 2021|
|Estimated Study Completion Date :||June 15, 2022|
Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
120 mg per dose in 12 mL liquid formulation
Other Name: ACY-1215
Placebo Comparator: placebo
Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
12 mL liquid formulation placebo
- 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
- Mean Average Pain Intensity (NRS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Week 4 ]Difference between mean average pain intensity
- Non-pain Neuropathic Signs (UENS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Week 12 ]Change in non-pain neuropathic signs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176472
|Contact: David Michelson, MDfirstname.lastname@example.org|