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

NCT ID: NCT07230197

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• 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. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Conditions

Fibromyalgia; Pregabalin; Dexmedetomidine

Study Design

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

Study Groups

Monotherapy group

Pregabalin

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.

Combination therapy group

Pregabalin with dexmedetomidine

Group Type: EXPERIMENTAL

Pregabalin with dexmedetomidine

Intervention Type: DRUG

In the pregabalin with dexmedetodimine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. The dose of dexmedetomidine administered via nasal spray is 4 sprays per day, with 1 spray in each nostril on both sides. The spray should be held for about 30 seconds before another 1 spray is administered in each nostril. A total of 4 sprays are given. The total dosage is 100 μg.

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 dexmedetomidine

In the pregabalin with dexmedetodimine group, the dose titration of pregabalin is identical with pregabalin monotherapy group. The dose of dexmedetomidine administered via nasal spray is 4 sprays per day, with 1 spray in each nostril on both sides. The spray should be held for about 30 seconds before another 1 spray is administered in each nostril. A total of 4 sprays are given. The total dosage is 100 μg.

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, venlafaxine 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

KY2025-217-03-07

Identifier Type: -

Identifier Source: org_study_id