Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

NCT06896994 | Recruiting DMC

• 1 other identifier: KY-2024-332-02-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the 1-week effects and safety of esketamine in combination with pregabalin and duloxetine to relieve pain in patients with postherpetic Neuralgia(PHN).

Conditions

Postherpetic Neuralgia

Keywords

Postherpetic Neuralgia; esketamine

Outcome Measures

Primary Outcomes (1)

• the mean of daily pain scores

  the mean of daily pain scores collected during week 1 of treatment measured using the Numerical Pain Rating Scale (NRS,, 0 represents no pain, and 10 represents the most severe pain.A higher score indicates more severe pain).

  during 1 week

Secondary Outcomes (8)

• Averaged weekly NRS score

  1 week, 2 weeks, 3 weeks, and 1 month after treatment

• percentages of patients having >50% reductions in 24-hour average pain severity during the first week

  during the first week

• the 12-item Short-Form Health Survey (SF-12) score

  1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

• the Pittsburgh Sleep Quality Index (PSQI) score

  1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

• the Patient Global Impression of Change scale (PGIC)

  1 day, 3 days, 7 days, 2 weeks, 3 weeks, and 1 month after treatment

Study Arms (2)

the esketamine group

EXPERIMENTAL

In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine. A total of 0.5 mg/kg of esketamine will be diluted in 50 mL of normal saline. The infusion will commence with an intravenous injection of 10 mg of esketamine over 1 minute, followed by a maintenance dose of 8 mg/h. The infusion rate will be adjusted based on the patients' tolerance levels.

Drug: esketamine group

the control group

PLACEBO COMPARATOR

In the control group, patients will receive pregabaline combined with duloxetine. Pregabaline will be administered at a dose of 50-75 mg, twice daily during the first 3 days of treatment, and increase to 300mg daily after 3-7days, then by an additional 150mg daily every 3-7 days as tolerated, up to a maximum daily dose of 600mg. Meanwhile, duloxetine will be prescribed at an initial daily dose of 30mg, and then gradually increased to 60 mg daily after one week if patients tolerate it well.

Drug: control group

Interventions

esketamine group DRUG

In the esketamine group, in addition to receiving the combination of pregabalin and duloxetine, patients will also undergo a single intravenous infusion of esketamine.

Also known as: pregabalin+duloxetine+esketamine

the esketamine group

control group DRUG

receiving the combination of pregabalin and duloxetine

Also known as: pregabalin+duloxetine

the control group

Eligibility Criteria

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

You may qualify if:

• Ages more than 18 years;
• Pain present for more than 3 months after healing of a herpes zoster skin rash;
• Has an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0= no pain, 10= worst possible pain)；
• Failed to respond to or tolerate the effective dose of pregabalin monotherapy.

You may not qualify if:

• Obstructive sleep apnoea syndrome;
• Those who receive interventional treatments;
• A history of systemic immune diseases, organ transplantation, or cancers;
• A history of severe cardiopulmonary, hepatic or renal dysfunction;
• A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
• Currently using monoamine oxidase inhibitors (MAOIs);
• Having untreated angle-closure glaucoma;
• Those suffering from increased intracranial pressure；
• Comorbid hyperthyroidism or phaeochromocytoma;
• Suspected or confirmed history of drug abuse;
• Having contraindications to esketamine, pregabaline or duloxetine;
• Communication difficulties;
• Women who are preparing for pregnancy, in the pregnancy or lactation period.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Xiaotangshan Hospital: collaborator
• The First Hospital of Fangshan District,Beijing: collaborator
• Beijing Ditan Hospital: collaborator
• Hengshui People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Fang Luo, M.D.

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo, M.D.

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Director of Department of Pain Management

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 26, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)