Study to Evaluate the Efficacy and Safety of DS-1971a for the Treatment of Diabetic Peripheral Neuropathic Pain (DPNP)

NCT02673866 | Withdrawn Phase 2

• 1 other identifier: DS1971-A-U202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• Change in weekly Average Daily Pain Score (ADPS)

  week 0 (Baseline) to Week 7

Secondary Outcomes (12)

• Response rate, proportion of subjects with ≥ 30% or ≥ 50% reduction

  week 0 (Baseline) to Week 7

• Effect of DS-1971a on Patient Global Impression of Change (PGIC) in neuropathic pain

  week 7

• Effect of DS-1971a on pain intensity and severity

  week 7

• Effect of DS-1971a on pain intensity and severity

  week 7

• Change in Hospital Anxiety and Depression Scale (HADS)

  week 0 (Baseline) to Week 7

Study Arms (5)

DS-1971a 400 mg TID

EXPERIMENTAL

DS-1971a 400 mg three times per day (TID)

Drug: DS-1971a; Drug: placebo

DS1971a 400 mg BID

EXPERIMENTAL

DS1971a 400 mg twice per day (BID)

Drug: DS-1971a; Drug: placebo

DS1971a 100 mg BID

EXPERIMENTAL

DS1971a 100 mg BID

Drug: DS-1971a; Drug: placebo

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Pregabalin

ACTIVE COMPARATOR

Pregabalin

Drug: placebo; Drug: pregabalin

Interventions

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

pregabalin DRUG

pregabalin

Pregabalin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Daiichi Sankyo: lead

MeSH Terms

Conditions

Neuralgia; Diabetes Mellitus; Hyperalgesia

Interventions

DS-1971a; Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Somatosensory Disorders; Sensation Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2016
• First Posted: February 4, 2016
• Study Start: February 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: July 27, 2016

Record last verified: 2016-07