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Completed

NCT Number: NCT04094662

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

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Key information

Conditions

Diabetic Peripheral Neuropathic Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

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About this study

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 or type 2 diabetes mellitus at screening
  • Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Exclusion criteria

  • HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
  • Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
  • Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Major psychiatric disorders at screening or randomization
  • Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening

Treatment and study plan

Mirogabalin

Drug

Mirogabalin tablets for oral administration

Other names: DS-5565

Placebo

Drug

Matching placebo tablets for oral administration

Primary outcomes

  1. Average Daily Pain Score (ADPS)

    Time frame: Baseline to Week 14

    The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.

Secondary outcomes

  1. ADPS responder rate

    Time frame: at Week 14

    Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.

  2. Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)

    Time frame: at Week 14

    The VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.

  3. Patient Global Impression of Change

    Time frame: at Week 14

    Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates.

  4. Average Daily Sleep Interference score (ADSIS)

    Time frame: at Week 14

    The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.

  5. Medical Outcome Study (MOS) sleep scale

    Time frame: at Week 14

    Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire:

    Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5.

    Part 2 - The participants give the number of hours per night for the average hours of sleep per night.

    Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep.

  6. Five Level EuroQol-5D (EQ-5D) version

    Time frame: at Week 14

    Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health.

Other outcomes

  1. Actigraphy signal collected from a wrist-worn medical-grade sensor

    Time frame: at Week 14

    Result of physical activity during waking hours and participants' sleep will be evaluated to explore a relationship between participants reported outcomes and actigraphy signal collected from a wrist-worn medical-grade sensor (ActiGraph GT9X Link). Only participants who signed a separate informed consent form for wearing medical-grade sensor will be included in this evaluation.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 19, 2019
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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