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CIPNNCT06711978

Comparison of the Efficacy and Safety of Mirogabalin and Duloxetine in Chemotherapy-induced Peripheral Neuropathy in a Randomized Controlled Trial: a Quality of Life Study in Cancer Survivors

A study testing Mirogabalin and Duloxetine in people with CIPN and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Mirogabalin and Duloxetine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2024to 15 Apr 2026
Phase
Interventional
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cancer survivors aged 19 years or older.
  • Peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination).
  • Patients experiencing at least grade 2 peripheral neuropathy as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with an average pain intensity of 4 or higher on the Numerical Rating Scale (NRS) during the past week, following the completion of chemotherapy.
  • Concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs [NSAIDs]) is permitted if the following conditions are met:
  • No new analgesics are introduced.
  • Current analgesics are not discontinued.
  • The total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment.
  • Ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization

Who cannot join

  • Patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (Patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.)
  • Patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation.
  • Pregnant or breastfeeding patients.
  • Patients with a history of prior treatment with other neurotoxic chemotherapeutic agents.
  • Patients with renal impairment (creatinine clearance < 30 mL/min) or hepatic dysfunction.
  • Patients with planned surgical procedures within 4 weeks of enrollment.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Yangsan Pusan National University Hospital

    Yangsan, 50612

Other trials in South Korea

About this study

To conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (CIPN).

There will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (CIPN).

Participants will:

  • Take drug duloxetine or a mirogabalin every day for 4 weeks.
  • Visit the clinic once every 2 weeks for checkups and tests
Being tested
Mirogabalin, Duloxetine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MirogabalinDrug

    Participants will receive Mirogabalin at a dose of twice daily for 4 weeks to manage CIPN pain.

  • DuloxetineDrug

    Participants will receive Duloxetine at a dose of once daily for 4 weeks to manage CIPN pain.

Study groups in NCT06711978
Study groupRoleWhat they receive
Drug: MirogabalinExperimentalNot described
Receives: Drug: Mirogabalin
Drug: DuloxetineActive comparatorNot described
Receives: Drug: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brief Pain Inventory-Short Form (BPI-SF)

    The Brief Pain Inventory-Short Form (BPI-SF) assesses pain severity and pain interference. Pain severity is assessed using four items and pain interference using seven items. Each item is rated from 0 to 10. The pain severity and pain interference scores each range from 0 to 10, with higher scores indicating greater pain severity or greater pain-related interference and therefore a worse outcome.

    Measured: Baseline, 2 weeks, and 4 weeks

Secondary outcomes (7)

  1. NCI-CTCAE v5.0

    Chemotherapy-induced peripheral neuropathy (CIPN) severity was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0. Severity is graded from Grade 1 to Grade 5, with higher grades indicating greater severity; Grade 5 represents death related to the adverse event.

    Measured: Baseline, 2 weeks, and 4 weeks

  2. EORTC-QLQ-CIPN20

    The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20-item module (EORTC QLQ-CIPN20) assesses sensory, motor, and autonomic symptoms associated with chemotherapy-induced peripheral neuropathy. Each item is rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much). Scale scores are linearly transformed to a range of 0 to 100, with higher scores indicating greater neuropathic symptom burden and a worse outcome.

    Measured: Baseline, 2 weeks, and 4 weeks

  3. EORTC QLQ-C30

    Most items are rated on a 4-point Likert scale ranging from 1 (not at all) to 4 (very much), while the two global health status/quality-of-life items are rated on a 7-point scale. All scale scores are linearly transformed to a range of 0 to 100. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning or quality of life, whereas higher scores on the symptom scales indicate greater symptom severity and a worse outcome.

    Measured: Baseline and 4 weeks

  4. Korean Neuropathic Pain Questionnaire (KNPQ)

    The Korean Neuropathic Pain Questionnaire (KNPQ) consists of 25 items assessing various characteristics of neuropathic pain. Twenty-two items are scored on an 11-point numerical rating scale ranging from 0 (no pain) to 10 (the most severe pain imaginable) and are summed to calculate the total score, ranging from 0 to 220. Higher scores indicate a greater neuropathic pain symptom burden.

    Measured: Baseline, 2 weeks, and 4 weeks

  5. sural SNAP amplitude

    Measured: At Baseline

  6. peroneal cMAP amplitude

    Measured: At Baseline

  7. Medication compliance & ADRs

    Measured: 2 weeks and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2024
  2. Study start1 Dec 2024
  3. Primary completion15 Apr 2026
  4. Study completion15 Apr 2026

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06711978
Sponsor's protocol ID
11-2024-072
Status last verified
Apr 2026
First submitted
26 Nov 2024
Last updated
26 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.

    PubMed 28119855

  • Misawa S, Denda T, Kodama S, Suzuki T, Naito Y, Kogawa T, Takada M, Suichi T, Shiosakai K, Kuwabara S; MiroCIP study group. Efficacy and safety of mirogabalin for chemotherapy-induced peripheral neuropathy: a prospective single-arm trial (MiroCIP study). BMC Cancer. 2023 Nov 11;23(1):1098. doi: 10.1186/s12885-023-11560-4.

    PubMed 37951905

  • Jordan B, Jahn F, Sauer S, Jordan K. Prevention and Management of Chemotherapy-Induced Polyneuropathy. Breast Care (Basel). 2019 Apr;14(2):79-84. doi: 10.1159/000499599. Epub 2019 Apr 10.

    PubMed 31798378

  • Seretny M, Currie GL, Sena ES, Ramnarine S, Grant R, MacLeod MR, Colvin LA, Fallon M. Incidence, prevalence, and predictors of chemotherapy-induced peripheral neuropathy: A systematic review and meta-analysis. Pain. 2014 Dec;155(12):2461-2470. doi: 10.1016/j.pain.2014.09.020. Epub 2014 Sep 23.

    PubMed 25261162

  • Hertz DL, Childs DS, Park SB, Faithfull S, Ke Y, Ali NT, McGlown SM, Chan A, Grech LB, Loprinzi CL, Ruddy KJ, Lustberg M. Patient-centric decision framework for treatment alterations in patients with Chemotherapy-induced Peripheral Neuropathy (CIPN). Cancer Treat Rev. 2021 Sep;99:102241. doi: 10.1016/j.ctrv.2021.102241. Epub 2021 Jun 9.

    PubMed 34174668

  • Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Lavoie Smith EM, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. J Clin Oncol. 2020 Oct 1;38(28):3325-3348. doi: 10.1200/JCO.20.01399. Epub 2020 Jul 14.

    PubMed 32663120

Questions about this trial

What is this clinical trial studying?

A study testing Mirogabalin and Duloxetine in people with CIPN and CIPN - Chemotherapy-Induced Peripheral Neuropathy, run by Pusan National University Yangsan Hospital at 1 site in South Korea.

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 8 inclusion and 6 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 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Brief Pain Inventory-Short Form (BPI-SF) (time frame: Baseline, 2 weeks, and 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06711978, which also lists 6 linked publications.

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 26 Aug 2026.

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