The Efficacy and Safety of Pregabalin Combined With Toludesvenlafaxine in Patients With Fibromyalgia

NCT ID: NCT07208357

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2027-08-31

Brief Summary

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of toludesvenlafaxine in FM. We hypothesize that the combination of pregabalin with toludesvenlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Conditions

Pain; Fibromyalgia; Pregabalin; Duloxetine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pregabalin monotherapy group

Group Type: ACTIVE_COMPARATOR

Pregabalin

Intervention Type: DRUG

In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.

Pregabalin with toludesvenlafaxine group

Group Type: EXPERIMENTAL

Pregabalin with toludesvenlafaxine

Intervention Type: DRUG

In the pregabalin with toludesvenlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Toludesvenlafaxine will be administered at 40 mg daily initially. If the initial dose is well-tolerated, the dose could be further escalated by 40 mg per day after 7 days, up to a maximum of 160 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be maintained, with the expectation that tolerance to AEs will develop. If AEs become intolerable, the dose will be decreased back to the previous dose, which was defined as the maximum tolerated dose. In the combination group, dose titration of both pregabalin and toludesvenlafaxine will be conducted simultaneously. If AEs occur, the next dose regimen should be determined in consultation with a clinical physician.

Interventions

Pregabalin

In the pregabalin monotherapy group, pregabalin will be initiated at 150 mg daily, divided into 2 or 3 doses per day, and increased to 300 mg per day after 3 to 7 days, subsequent increases of 150 mg daily may occur every 3 to 7 days, based on individual patient response and tolerability, with a maximum dose of 600 mg daily.

Intervention Type: DRUG

Pregabalin with toludesvenlafaxine

In the pregabalin with toludesvenlafaxine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. Toludesvenlafaxine will be administered at 40 mg daily initially. If the initial dose is well-tolerated, the dose could be further escalated by 40 mg per day after 7 days, up to a maximum of 160 mg per day. With each dose increase, AEs will be assessed and categorized as mild, moderate, or severe. If participants tolerate the current dose for 2 to 3 days, it will be maintained, with the expectation that tolerance to AEs will develop. If AEs become intolerable, the dose will be decreased back to the previous dose, which was defined as the maximum tolerated dose. In the combination group, dose titration of both pregabalin and toludesvenlafaxine will be conducted simultaneously. If AEs occur, the next dose regimen should be determined in consultation with a clinical physician.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
• Aged 18 years or older;
• Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
• Numeric rating scale (NRS) score ≥ 4 at baseline;
• Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
• Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
• Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.

Exclusion Criteria

• History of hypersensitivity to pregabalin, toludesvenlafaxine or any of its excipients;
• History of epilepsy, or depression requiring antidepressant medications;
• Pregnancy or breastfeeding;
• Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
• With acute or chronic pain conditions other than FM.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fang Luo

Director, Department of Pain Management, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Beijing, Beijing 100070

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Fang Luo

Role: CONTACT

13611326978@163.com

+8613611326978

Facility Contacts

Fang Luo

Role: primary

13611326978@163.com

+8613611326978

Related Links

https://pubmed.ncbi.nlm.nih.gov/32345589/

Mathieson S, Lin C-WC, Underwood M, Eldabe S. Pregabalin and gabapentin for pain. BMJ. 2020;369:m1315. doi: 10.1136/bmj.m1315

https://pubmed.ncbi.nlm.nih.gov/37461044/

Migliorini F, Maffulli N, Eschweiler J, Baroncini A, Bell A, Colarossi G. Duloxetine for fibromyalgia syndrome: a systematic review and meta-analysis. J Orthop Surg Res. 2023;18(1):504. doi: 10.1186/s13018-023-03995-z.

https://pubmed.ncbi.nlm.nih.gov/26982602/

Gilron I, Chaparro LE, Tu D, Holden RR, Milev R, Towheed T, et al. Combination of pregabalin with duloxetine for fibromyalgia: a randomized controlled trial. Pain. 2016;157(7):1532-40. doi: 10.1097/j.pain.0000000000000558.

Other Identifiers

KY2025-217-03-05

Identifier Type: -

Identifier Source: org_study_id