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Study of Mirogabalin for Central Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03901352
Recruitment Status : Completed
First Posted : April 3, 2019
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Study Description
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Brief Summary:
Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Condition or disease Intervention/treatment Phase
Central Neuropathic Pain Drug: Placebo Drug: Mirogabalin Phase 3

Detailed Description:

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

During the Double-blind Phase, participants will be randomized into parallel treatment arms.

During the Open Extension Phase, all participants will be assigned to a single group.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: During the Double-blind Phase, masking will be triple (as shown above). During the Open Extension Phase, there will be no masking - the allocation is not applicable.
Primary Purpose: Treatment
Official Title: An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension
Actual Study Start Date : March 12, 2019
Actual Primary Completion Date : December 28, 2020
Actual Study Completion Date : December 28, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Mirogabalin

The patients with creatinine clearance (CLcr) ≥ 60 mL/min: Mirogabalin 20 mg or 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.

The patients with creatinine clearance (CLcr) 30 to < 60 mL/min: Mirogabalin 10 mg or 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose

 Drug: Mirogabalin
Mirogabalin tablets for oral administration
Other Name: DS-5565
Placebo Comparator: Placebo
Placebo (14-weeks)
 Drug: Placebo
Matching placebo tablets for oral administration
Other Name: Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Average Daily Pain Score (ADPS) Response 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) [ Time Frame: Baseline to Week 14 ]

    Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:

    Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe)

    Part 2 - a 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

    Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense 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: Baseline to 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spinal cord injury (SCI) due to trauma
  • American Spinal Injury Association impairment scale A, B, C, or D

Exclusion Criteria:

  • Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
  • Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI
  • Major psychiatric disorders within 1 year prior to screening
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03901352


Locations
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Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo, Inc.
More Information
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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03901352    
Other Study ID Numbers: DS5565-A-J314
194653 ( Registry Identifier: JAPIC CTI )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: http://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Central neuropathic pain
Developmental phase III
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Pain
Neurologic Manifestations