Diabetic Peripheral NeuropathyPhase 2NCT01496365
Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2 study testing DS-5565 tablet and pregabalin capsule in people with Diabetic Peripheral Neuropathy, run by Daiichi Sankyo at 78 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- DS-5565 tablet and pregabalin capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 452 participants
- Where
- 78 sitesUnited States
- Study dates
- 28 Nov 2011to 7 Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years of age
- Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
- Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
- At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
- At Randomization, a pain score of ≥ 40 mm on the SF-MPQ VAS and an ADPS of ≥ 4 on the 11-point NRS, the latter calculated from a minimum of 4 pain ratings in daily diaries obtained during the 1-week Baseline Period (prior to randomization)
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- Creatinine clearance > 60 mL/min (estimated using the Cockcroft-Gault equation)
- Antidiabetic and other medications anticipated to remain stable and constant during the study period
- Women of child bearing potential (WOCBP) must be using an adequate method of contraception as detailed in the protocol to avoid pregnancy during the study and for 4 weeks after study completion
Who cannot join
- Diagnosis of mononeuropathy
- Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
- Major psychiatric disorders
- Have had a malignancy other than basal cell carcinoma within the past 2 years
- At Visit 1, have a white blood cell count < 2500/mm3, neutrophil count < 1500/mm3, or platelet count < 100 x 103/mm3
- Clinically significant unstable diabetes mellitus, unstable hepatic, respiratory, or hematologic illness, unstable cardiovascular disease (including myocardial infarction in the 3 months prior to Visit 1), or symptomatic peripheral vascular disease
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- Clinically significant findings on the Screening ECG
- History of pernicious anemia, untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or human immunodeficiency virus infection
- Amputations of body parts other than toes
- Prior therapeutic failure of pregabalin or gabapentin (considered unresponsive or intolerant to treatment); therapeutic failure implies lack of efficacy following full titration to effective doses (eg, 300 mg/day for pregabalin)
- Known hypersensitivity to pregabalin or gabapentin
- Requirement for concomitant anticonvulsant and antidepressant therapy, with the exception of stable doses of SSRIs
- Neurologic disorders unrelated to DPN that may confound the assessment of pain associated with DPN
- Skin conditions that could alter sensation
- Other sources of pain that may confound assessment or self-evaluation of the pain due to DPN
- Abuse of prescription medications, street drugs or alcohol (including alcohol dependence) within the last 1 year
- Current enrollment in another investigational study, participation in another investigational study with the past 30 days, or other current or recent use of any investigational drug
- Pregnancy (as based on lab test results) or breast feeding
- Laboratory values exceeding limits listed in Table 4.1 of the protocol
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Study site
Albany, New York, 12205
Study site
Austin, Texas, 78731
Study site
Birmingham, Alabama, 35242
Study site
Boulder, Colorado, 80304
Study site
Bradenton, Florida, 34208
Study site
Brockton, Massachusetts, 02301
Study site
Brooksville, Florida, 34601
Study site
Buena Park, California, 90620
Study site
Burbank, California, 91505
Study site
Charleston, South Carolina, 29407
Study site
Chattanooga, Tennessee, 37411
Study site
Chino, California, 91710
Study site
Cincinnati, Ohio, 45245
Study site
Clearwater, Florida, 33756
Study site
Colorado Springs, Colorado, 80920
Study site
Columbus, Georgia, 31909
Study site
Cromwell, Connecticut, 06416
Study site
Dallas, Texas, 75230
Study site
Dallas, Texas, 75231
Study site
Dayton, Ohio, 45439
Study site
Denver, Colorado, 80209
Study site
Duncansville, Pennsylvania, 16635
Study site
El Paso, Texas, 79925
Study site
Evansville, Indiana, 44714
Study site
Fairfield, Connecticut, 06824
Study site
Farmington Hills, Michigan, 48025
Study site
Florissant, Missouri, 63031
Study site
Fresno, California, 93726
Study site
Gainesville, Georgia, 30501
Study site
Golden, Colorado, 80401
Study site
Greensburg, Pennsylvania, 15601
Study site
Greer, South Carolina, 29561
Study site
Greer, South Carolina, 29651
Study site
Hallandale, Florida, 33009
Study site
Hot Springs, Arkansas, 71913
Study site
Houston, Texas, 77030
Study site
Huntington Beach, California, 92648
Study site
Huntsville, Alabama, 35801
Study site
Hyattsville, Maryland, 20782
Study site
Kansas City, Missouri, 64114
Study site
Lakewood, California, 90712
Study site
Las Vegas, Nevada, 89106
Study site
Las Vegas, Nevada, 89119
Study site
Las Vegas, Nevada, 89123
Study site
Little Rock, Arkansas, 72205
Study site
Lomita, California, 90717
Study site
Long Beach, California, 90806
Study site
Madisonville, Kentucky, 42431
Study site
Marietta, Georgia, 30060
Study site
Mesa, Arizona, 85206
Study site
Miami, Florida, 33143
Study site
Miami, Florida, 33169
Study site
Mt. Pleasant, South Carolina, 29464
Study site
New Port Richey, Florida, 34217
Study site
New Port Richey, Florida, 34652
Study site
Norfolk, Virginia, 23507
Study site
Norfolk, Virginia, 23510
Study site
Olive Branch, Mississippi, 38654
Study site
Omaha, Nebraska, 68131
Study site
Orlando, Florida, 32806
Study site
Paducah, Kentucky, 42003
Study site
Phoenix, Arizona, 85023
Study site
Phoenix, Arizona, 85028
Study site
Renton, Washington, 98057
Study site
Richmond, Virginia, 23249
Study site
San Antonio, Texas, 78154
Study site
San Antonio, Texas, 78229
Study site
Santa Monica, California, 90404
Study site
Spokane, Washington, 99207
Study site
St Louis, Missouri, 63141
Study site
Sugar Land, Texas, 77478
Study site
Sunrise, Florida, 33351
Study site
Toledo, Ohio, 43623
Study site
Tucson, Arizona, 85712
Study site
Tulsa, Oklahoma, 74104
Study site
Virginia Beach, Virginia, 23454
Study site
Walnut Creek, California, 94598
Study site
Warwick, Rhode Island, 02886
About this study
Official title: A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Read the detailed description
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.
There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- DS-5565 tablet, pregabalin capsule, Placebo tablet, placebo capsule
- Keywords
- Keywords: pain, diabetes, neuropathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-5565 tabletDrug
5mg and 10mg tablets
pregabalin capsuleDrug
Also called Lyrica
75mg and 150mg over-encapsulated
Placebo tabletDrug
Also called placebo tablet matching DS-5565 tablet
placebo capsuleDrug
Also called placebo capsule matching over-encapsulated pregabalin
| Study group | Role | What they receive |
|---|---|---|
| DS-5565 5mg nighttime | Experimental | DS-5565 5 mg/day (one 5 mg tablet at bedtime) Receives: Drug: DS-5565 tablet; Drug: placebo capsule |
| DS-5565 10 mg at bedtime | Experimental | DS-5565 10 mg/day (one 10 mg tablet at bedtime) Receives: Drug: DS-5565 tablet; Drug: placebo capsule |
| DS-5565 15 mg at bedtime | Experimental | DS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime) Receives: Drug: DS-5565 tablet; Drug: placebo capsule |
| DS-5565 20 mg total per day | Experimental | DS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime) Receives: Drug: DS-5565 tablet; Drug: placebo capsule |
| DS-5565 30 mg total per day | Experimental | DS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime) Receives: Drug: DS-5565 tablet; Drug: placebo capsule |
| Pregabalin 300 mg total per day | Active comparator | Pregabalin 300 mg/day (two 150 mg capsules, in the morning and at bedtime) Receives: Drug: pregabalin capsule; Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Secondary outcomes (12)
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The least square means of ADPS (assessed by MMRM) are reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Average Daily Sleep Interference Score (ADSIS) is the weekly average of patient-reported sleep interference (rated every morning on a numerical scale of 0 = "pain did not interfere with sleep" to 10 = "pain completely interfered with sleep" over the past 24 h), where higher scores indicate worse outcome.The change from baseline to Week 5 in ADSIS is being reported as the average of the last 7 available daily scores. The greater the negative value, the greater the improvement in sleep.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3:
throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ sensory and affective scores are being reported. The greater the negative value, the greater the improvement in sensory and affective scores.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ sensory score is the sum of 11 pain descriptors each scored from 0 to 3: throbbing, shooting, stabbing, sharp cramping, gnawing, hot-burning, aching, heavy, tender, and splitting. Thus, the SF-MPQ sensory score ranges from 0 to 33, where lower scores indicate a better outcome. The SF-MPQ affective score is the sum of four pain descriptors each scored from 0 to 3: tiring-exhausting, sickening, fearful, and punishing cruel. Thus, SF-MPQ affective score ranges from 0 to 12, where lower scores indicate a better outcome. The SF-MPQ total score comprises the sum of the sensory and affective scores. The SF-MPQ VAS ranges from 0 (no pain) to 100 (worst possible pain), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ total score and VAS are being reported. The greater the negative value, the greater the improvement in total score (sensory and affective scores) and VAS pain.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The SF-MPQ present pain intensity ranges from 0 (no pain) to 5 (excruciating), where lower scores indicate a better outcome. The change from baseline to Week 5 in SF-MPQ present pain intensity is being reported. The greater the negative value, the greater the improvement in present pain intensity.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of interference subscale is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in interference with daily functions.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of worst pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of least pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The range of average pain intensity in the last 24 hours is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. The greater the negative value, the greater the improvement in worst, least, and average pain intensity.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of pain right now is 0-10, where lower scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For pain right now, the greater the negative value, the greater the improvement.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
The Modified Brief Pain Inventory (BPI) includes Interference with Daily Functions Subscale, Worst Pain Intensity, Least Pain Intensity, Average Pain Intensity, Pain Right Now, and Relief From Pain. The range of % relief from pain is 0-100, where higher scores indicate a better outcome. The change from baseline to Week 5 in Modified Brief Pain Inventory is being reported. For relief from pain, the higher the score, the greater the improvement in pain relief.
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Patient Global Impression of Change (PGIC) has a range of 7 possible responses for overall status since start of the study, where 0 was defined as 'Very much improved' and 7 was defined as 'Very much worse'. Lower scores indicate a better outcome. PGIC was analyzed based on the following definitions: Participant's overall status was minimally improved or better (ie, score ≤3) or Participant's overall status was much improved or better (ie, score ≤ 2).
Measured: Baseline up to Week 5 postdose, up to 10 months total follow up
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) which began or worsened in severity after the first administration of study drug. Drug-related TEAEs included AEs that were considered related to the study drug as judged by the Investigator. TEAEs were classified according to MedDRA 14.1.
Measured: From the time of signing the informed consent form (ICF) up to 10 months postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study start28 Nov 2011
- Primary completion7 Sep 2012
- Study completion7 Sep 2012
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 Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Domenico Merante, MD, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496365
- Sponsor's protocol ID
- DS5565-A-U201
- Status last verified
- Dec 2020
- First submitted
- 19 Dec 2011
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT01496365
- Acronym / sponsor ID
- DS5565-A-U201
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Keywords: pain, diabetes, neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 28 Nov 2011 (actual)
- Primary completion
- 7 Sep 2012 (actual)
- Study completion
- 7 Sep 2012 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability and effectiveness of DS-5565 compared to placebo (inactive substance) and pregabalin in diabetic subjects with DPN.
Detailed description
Diabetic peripheral neuropathy (DPN) affects up to 50% of patients who have diabetes for at least 25 years. Up to 26% of all patients with DPN experience neuropathic pain. DPN pain contributes to sleep disorders, depression, and anxiety, which together may have an impact on a patient's well-being and quality of life.
There are currently several drugs used to treat painful DPN. For example, Lyrica® (pregabalin) is approved by the United States Food and Drug Administration (FDA) to treat neuropathic pain associated with DPN and is commonly prescribed. The dosage of the FDA-approved drugs is limited by side-effects such as dizziness, sleepiness, weight gain and swelling of the hands, legs, and feet. As a result, many patients suffering from DPN pain do not get satisfactory pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| DS-5565 5mg nighttime | Experimental | Drug: DS-5565 tablet, Drug: placebo capsuleDS-5565 5 mg/day (one 5 mg tablet at bedtime) |
| DS-5565 10 mg at bedtime | Experimental | Drug: DS-5565 tablet, Drug: placebo capsuleDS-5565 10 mg/day (one 10 mg tablet at bedtime) |
| DS-5565 15 mg at bedtime | Experimental | Drug: DS-5565 tablet, Drug: placebo capsuleDS-5565 15 mg/day (one 5 mg tablet plus one 10 mg tablet at bedtime) |
| DS-5565 20 mg total per day | Experimental | Drug: DS-5565 tablet, Drug: placebo capsuleDS-5565 20 mg/day (one 10 mg tablet in the morning and one 10 mg tablet at bedtime) |
| DS-5565 30 mg total per day | Experimental | Drug: DS-5565 tablet, Drug: placebo capsuleDS-5565 30 mg/day (one 5 mg tablet plus one 10 mg tablet in the morning and one 5 mg tablet plus one 10 mg tablet at bedtime) |
| Pregabalin 300 mg total per day | Active comparator | Drug: pregabalin capsule, Drug: Placebo tabletPregabalin 300 mg/day (two 150 mg capsules, in the morning and at bedtime) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years of age
- Able to give informed consent and willing to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- Type 1 or type 2 diabetes with a hemoglobin A1c (HbA1c) ≤ 10% at Screening and on a stable antidiabetic medication regimen for at least 30 days prior to Screening (insulin therapy is acceptable)
- Painful distal symmetrical sensorimotor polyneuropathy (as per American Society of Pain Educators guidelines ) diagnosed for at least 6 months, based on neurological history and/or examination; diagnosis includes absent or reduced deep tendon reflexes at both ankles
- At Screening, a pain score of ≥ 40 mm on the SF-MPQ VAS
Key exclusion criteria (19 listed)
- Diagnosis of mononeuropathy
- Use of concomitant medications that may confound assessments of efficacy and/or safety (see Section 5.2)
- Major psychiatric disorders
- Have had a malignancy other than basal cell carcinoma within the past 2 years
- At Visit 1, have a white blood cell count < 2500/mm3, neutrophil count < 1500/mm3, or platelet count < 100 x 103/mm3
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 |
|---|---|---|
| DS-5565 tablet5mg and 10mg tablets | Drug | DS-5565 10 mg at bedtime, DS-5565 15 mg at bedtime, DS-5565 20 mg total per day, DS-5565 30 mg total per day, DS-5565 5mg nighttime |
| pregabalin capsuleAlso: Lyrica75mg and 150mg over-encapsulated | Drug | Pregabalin 300 mg total per day |
| Placebo tabletAlso: placebo tablet matching DS-5565 tablet | Drug | Pregabalin 300 mg total per day |
| placebo capsuleAlso: placebo capsule matching over-encapsulated pregabalin | Drug | DS-5565 10 mg at bedtime, DS-5565 15 mg at bedtime, DS-5565 20 mg total per day, DS-5565 30 mg total per day, DS-5565 5mg nighttime |
Primary outcome
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Average daily pain score (ADPS) is a participant-reported instrument that measures pain intensity using an 11-point numeric rating scale (NRS) where 0 is defined as no pain and 10 is defined as worst possible pain. Higher scores indicate worse pain intensity level. The change from baseline to Week 5 is reported where a negative value is considered an improvement in pain intensity. A minimally meaningful effect was defined as a decrease of at least 1.0 point [scale of 0 to 10] versus placebo).
12 secondary outcomes
Least Square Means of Average Daily Pain Score by Week Mixed Effects Model for Repeated Measures (MMRM) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Average Daily Pain Score Responder Rates Based on ≥30% and ≥50% Decrease From Baseline at Endpoint) Following Treatment With DS-5565 or Placebo Compared to Pregabalin
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to End-of-Treatment in Average Daily Sleep Interference Score Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Sensory and Affective Scores Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score and Visual Analog Scale Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Short-Form McGill Pain Questionnaire (SF-MPQ) Present Pain Intensity Change From Baseline to Endpoint Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified Brief Pain Inventory (BPI) Subscale, Interference With Daily Functions, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscales, Worst, Least and Average Pain Intensity, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Pain Right Now, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Mean Change From Baseline to Endpoint of Modified BPI Subscale, Relief From Pain, Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Patient Global Impression of Change at End-of-Treatment or Early Termination Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: Baseline up to Week 5 postdose, up to 10 months total follow up
Drug-related Treatment-Emergent Adverse Events (n ≥2 Participants in Any Treatment Group) Following Treatment With DS-5565 Compared to Pregabalin and Placebo
Time frame: From the time of signing the informed consent form (ICF) up to 10 months postdose
Results and safety
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Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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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.
Domenico Merante, MD study director
Daiichi Sankyo
78 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 DS-5565 tablet and pregabalin capsule in people with Diabetic Peripheral Neuropathy, run by Daiichi Sankyo at 78 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 9 inclusion and 19 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 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. 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 5 Jan 2021). 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?
Mean Change From Baseline to Week 5 in Average Daily Pain Score (ADPS) Following Treatment With DS-5565 Compared to Pregabalin and Placebo (time frame: Baseline up to Week 5 postdose, up to 10 months total follow up). 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 5 Jan 2021.