Neuropathic PainPhase 2NCT02673866
Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
A Phase 2 study testing DS-1971a and pregabalin in people with Neuropathic Pain and Diabetes, run by Daiichi Sankyo.
Trial summary
The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will be generally well tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Diabetes
- What is being tested?
- DS-1971a and pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age.
- Body mass index (BMI) ≤ 40 kg/m2 at screening.
- Able to give written informed consent.
- Type 1 or 2 diabetes.
- HbA1c ≥ 7.0% and < 9% at screening.
- On a stable anti-diabetic medication regimen (unchanged dose over the last 3 months for diabetes) prior to screening (insulin therapy is acceptable); no recent (i.e., within the previous 6 months) hospitalizations due to noncompliance or uncontrolled diabetes or introduction of new medications.
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- ADPS of ≥ 4 on the 11-point numeric rating scale (NRS) over the past 7 days prior to randomization (based on completion of at least 4 daily pain diaries during the 7-day baseline period prior to randomization).
- Painful distal symmetrical sensorimotor polyneuropathy diagnosed for at least 6 months (positive Douleur Neuropathique 4 [DN4] questionnaire at screening).
- Women of child bearing potential (WOCBP) must be willing to use double-barrier contraception for the entire study.
- Subjects who, in the judgement of the Investigator, are likely to be compliant during the study.
Who cannot join
- Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g., severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the Investigator would interfere with study participation or assessment of safety and tolerability.
- Subjects who present with active cancer or human immunodeficiency virus (HIV) infection.
- Creatinine clearance rate < 60 mL/min.
- Current diagnosis of epilepsy or any seizure disorder requiring chronic therapy with anti-epileptics.
- Diagnosis of mononeuropathy.
- Subjects who are at risk of suicide as defined by their responses to the C-SSRS or in the opinion of the Investigator. Note: Subjects answering "yes" to any of the questions about suicidal ideation/intent/behaviors occurring within the past 12 months must be excluded (C-SSRS Suicide Ideation section-Questions 1, 2, 3, 4, or 5; C-SSRS Suicidal Behavior section, any of the suicide behaviors questions). Such subjects should be referred immediately to a mental health professional for appropriate evaluation.
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- Any major uncontrolled psychiatric disorders such as bipolar disorder, schizophrenia, or major depression.
- Abnormal liver function (aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 2.5 × upper limit of normal (ULN), bilirubin > 1.5 ULN).
- Subjects with history of gout, and/or urate nephrolithiasis, and/or with abnormally low serum uric acid (below the lowest laboratory reference range both in men and women) at baseline.
- Other sources of pain that may confound assessment or self-evaluation of DPNP such as disseminated osteoarthritis or rheumatoid arthritis.
- Neurologic disorders unrelated to diabetic peripheral neuropathy that may confound the assessment of DPNP.
- Amputation of lower extremity (including above- and below-knee amputation) due to diabetes mellitus.
- Unable or unwilling to discontinue current medications for chronic pain for the duration of the trial.
- Use of concomitant medications (i.e., opioids, tricyclic anti-depressives, and/or gamma retinoids) that may confound assessments of efficacy and/or safety.
- Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 5.6).
- Abuse or dependence on prescription medications, street drugs, or alcohol within the last year.
- Women who are pregnant or breast-feeding or intend to become pregnant during the study period.
- Known hypersensitivity to pregabalin or DS-1971a and/or known treatment failure on pregabalin.
- Subjects who are a family member of the Investigator or any associate, colleague, and employee assisting in the conduct of the study (secretary, nurse, technician).
- Subjects who cannot be contacted by phone in an emergency.
- Participated in another clinical study within 30 days prior to screening or is receiving other investigational agents.
- Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
About this study
Official title: A Randomized Double-Blind Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will be generally well tolerated.
- Conditions
- Neuropathic Pain, Diabetes
- Being tested
- DS-1971a, placebo, pregabalin
- Keywords
- Diabetic Peripheral Neuropathic Pain (DPNP), Diabetes, Pregabalin, Spontaneous Pain, Hyperalgesia, Allodynia, Average Daily Pain Score (ADPS), Pain Associated Sleep Interference
- Medical subject headings
- Neuralgia, Diabetes Mellitus, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DS-1971aDrug
placeboDrug
pregabalinDrug
pregabalin
| Study group | Role | What they receive |
|---|---|---|
| DS-1971a 400 mg TID | Experimental | DS-1971a 400 mg three times per day (TID) Receives: Drug: DS-1971a; Drug: placebo |
| DS1971a 400 mg BID | Experimental | DS1971a 400 mg twice per day (BID) Receives: Drug: DS-1971a; Drug: placebo |
| DS1971a 100 mg BID | Experimental | DS1971a 100 mg BID Receives: Drug: DS-1971a; Drug: placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
| Pregabalin | Active comparator | Pregabalin Receives: Drug: placebo; Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weekly Average Daily Pain Score (ADPS)
Measured: week 0 (Baseline) to Week 7
Secondary outcomes (12)
Response rate, proportion of subjects with ≥ 30% or ≥ 50% reduction
Response rate, defined as the proportion of subjects with ≥ 30% or ≥ 50% reduction
Measured: week 0 (Baseline) to Week 7
Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain
Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain
Measured: week 7
Effect of DS-1971a on pain intensity and severity
Effect of DS-1971a on pain intensity and severity as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Measured: week 7
Effect of DS-1971a on pain intensity and severity
Effect of DS-1971a on pain interference with daily activities as assessed by a modified Brief Pain Inventory Short Form (BPI-SF)
Measured: week 7
Change in Hospital Anxiety and Depression Scale (HADS)
Change as assessed by the Hospital Anxiety and Depression Scale (HADS)
Measured: week 0 (Baseline) to Week 7
Change in pain-associated sleep interference score (ADSIS)
Change in pain-associated sleep interference as assessed by average daily sleep interference score (ADSIS)
Measured: week 0 (Baseline) to Week 7
Changes in subject general health status
Changes in subject general health status as assessed by the Short Form 36 (SF-36) questionnaire
Measured: week 0 (Baseline) to Week 7
number and severity of Adverse Events (AEs), clinical laboratory abnormalities, physical examinations, ECGs, vital signs
number and severity of AEs, clinical laboratory abnormalities, physical examinations, 12-lead electrocardiograms (ECGs), and vital signs
Measured: week 0 (Baseline) to Week 7
change in Columbia-Suicide Severity Rating Scale (C SSRS)
change in Columbia-Suicide Severity Rating Scale (C SSRS)
Measured: week 0 (Baseline) to Week 7
Effects of treatments on neuropathic pain components
Effects of treatments on neuropathic pain components assessed with the Neuropathic Pain Symptom Inventory (NPSI)
Measured: week 7
change in weekly ADPS responder rate
Effects of DS-1971a versus pregabalin (titrated to 300 mg daily) in weekly ADPS responder rate at Week 7
Measured: week 7
Rescue medication usage
Rate of rescue medication usage
Measured: week 0 through week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: reassessment of phase 2 study indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673866
- Sponsor's protocol ID
- DS1971-A-U202
- Status last verified
- Jul 2016
- First submitted
- 28 Jan 2016
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Placebo and Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
- ClinicalTrials.gov ID
- NCT02673866
- Acronym / sponsor ID
- DS1971-A-U202
- Conditions
- Neuropathic Pain, Diabetes
- Keywords
- Diabetic Peripheral Neuropathic Pain (DPNP), Diabetes, Pregabalin, Spontaneous Pain, Hyperalgesia, Allodynia, Average Daily Pain Score (ADPS), Pain Associated Sleep Interference
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: reassessment of phase 2 study indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 4 Feb 2016 (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.
The hypothesis of this Phase 2 study is that at least 1 dose regimen of DS-1971a will demonstrate clinical superiority to placebo in managing pain associated with DPNP, and will be generally well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DS-1971a 400 mg TID | Experimental | Drug: DS-1971a, Drug: placeboDS-1971a 400 mg three times per day (TID) |
| DS1971a 400 mg BID | Experimental | Drug: DS-1971a, Drug: placeboDS1971a 400 mg twice per day (BID) |
| DS1971a 100 mg BID | Experimental | Drug: DS-1971a, Drug: placeboDS1971a 100 mg BID |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
| Pregabalin | Active comparator | Drug: placebo, Drug: pregabalinPregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female ≥ 18 years of age.
- Body mass index (BMI) ≤ 40 kg/m2 at screening.
- Able to give written informed consent.
- Type 1 or 2 diabetes.
- HbA1c ≥ 7.0% and < 9% at screening.
Key exclusion criteria (22 listed)
- Clinically significant unstable neurologic, psychiatric, ophthalmologic, hepatobiliary, respiratory, or hematologic illness or unstable cardiovascular disease (e.g., severe hypotension, uncontrolled cardiac arrhythmia, or myocardial infarction) or any other concurrent disease within 12 months prior to screening that in the opinion of the Investigator would interfere with study participation or assessment of safety and tolerability.
- Subjects who present with active cancer or human immunodeficiency virus (HIV) infection.
- Creatinine clearance rate < 60 mL/min.
- Current diagnosis of epilepsy or any seizure disorder requiring chronic therapy with anti-epileptics.
- Diagnosis of mononeuropathy.
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-1971a | Drug | DS-1971a 400 mg TID, DS1971a 100 mg BID, DS1971a 400 mg BID |
| placebo | Drug | DS-1971a 400 mg TID, DS1971a 100 mg BID, DS1971a 400 mg BID, Placebo, Pregabalin |
| pregabalinpregabalin | Drug | Pregabalin |
Primary outcome
Change in weekly Average Daily Pain Score (ADPS)
Time frame: week 0 (Baseline) to Week 7
12 secondary outcomes
Response rate, proportion of subjects with ≥ 30% or ≥ 50% reduction
Time frame: week 0 (Baseline) to Week 7
Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain
Time frame: week 7
Effect of DS-1971a on pain intensity and severity
Time frame: week 7
Effect of DS-1971a on pain intensity and severity
Time frame: week 7
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: week 0 (Baseline) to Week 7
Change in pain-associated sleep interference score (ADSIS)
Time frame: week 0 (Baseline) to Week 7
Changes in subject general health status
Time frame: week 0 (Baseline) to Week 7
number and severity of Adverse Events (AEs), clinical laboratory abnormalities, physical examinations, ECGs, vital signs
Time frame: week 0 (Baseline) to Week 7
change in Columbia-Suicide Severity Rating Scale (C SSRS)
Time frame: week 0 (Baseline) to Week 7
Effects of treatments on neuropathic pain components
Time frame: week 7
change in weekly ADPS responder rate
Time frame: week 7
Rescue medication usage
Time frame: week 0 through week 7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DS-1971a and pregabalin in people with Neuropathic Pain and Diabetes, run by Daiichi Sankyo.
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 10 inclusion and 22 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: withdrawn, as of the sponsor's last update on 27 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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 weekly Average Daily Pain Score (ADPS) (time frame: week 0 (Baseline) to Week 7). 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 27 Jul 2016.