Efficacy and Safety of Pregabalin/Tizanidine vs. Pregabalin in Patients With Fibromyalgia

NCT07382921 | Not Yet Recruiting DMC

• 1 other identifier: KY2025-217-03-08
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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.Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.we carried out an open-label clinical trial in order to evaluate the efficacy and safety of combined treatment with tizanidine and pregabalin for pain in FM.

Conditions

Fibromyalgia; Pregabalin; Pain

Outcome Measures

Primary Outcomes (1)

• Average pain intensity

  The primary outcome is change from baseline to 12 weeks of treatment in average pain intensity during the last 7 days on an 11-point rating scale (ranging from 0 = "no pain" to 10 = "unbearable pain") using the first item from the symptom part of the Fibromyalgia Impact Questionnaire Revised (FIQR)

  baseline , 12 weeks

Secondary Outcomes (9)

• Fibromyalgia Impact Questionnaire Revised

  weekly(from baseline to 24 weeks)

• Medical Outcome Study Short Form 36 Health Survey (SF-36)

  baseline , 4, 8, 12, 16, 20, and 24 weeks

• The Patient's Global Assessment

  baseline , 4, 8, 12, 16, 20, and 24 weeks

• The Beck II Depression Inventory

  baseline , 4, 8, 12, 16, 20, and 24 weeks

• The Pittsburgh Sleep Quality Index

  baseline , 4, 8, 12, 16, 20, and 24 weeks

Study Arms (2)

Pregabalin monotherapy group

ACTIVE COMPARATOR

Drug: Pregabalin

Pregabalin with tizanidine group

EXPERIMENTAL

Drug: Pregabalin with tizanidine

Interventions

Pregabalin DRUG

The patients receive open-label pregabalin (Pfizer Pharmaceutical Co. Ltd, New York) titration therapy. In the first week, patients receive the starting dose of 150 mg/day (75 mg twice daily) escalated, based on efficacy and tolerability, at weekly visits to increase by 150 mg per week. A final dose of 450 mg/day (225 mg twice daily). However, during this flexible dose titration, the final dose arrived at during the maximal tolerated dose week (week 3 of the treatment period) could be lower than the ceiling dose of 450 mg, if the patient could not tolerate the dose increase, it is reduce to the pre-escalation dose. Thus, this trial will not use a forced titration to the ceiling dose of 450 mg/day.

Pregabalin monotherapy group

Pregabalin with tizanidine DRUG

All patients receive tizanidine in an open-label fashion. The tizanidine dose is slowly escalated over approximately 3 weeks. The initial dosage is 2 mg/d at bedtime. The dosage is increased by 2 mg every 2 days in the first week in 3 divided doses. The dosage is then increased more rapidly by 4 mg every 2 days in the second week divided 3 times a day. During the third week, the dose was further escalated by 6 mg every 2 days to a maximum of 24 mg/d divided 3 times a day. If a patient could not tolerate a particular current specific dosage increase because of side effects, he or she is maintain at the previous dosage during the trial period. The patients receive open-label pregabalin (Pfizer Pharmaceutical Co. Ltd, New York) titration therapy. In the first week, patients receive the starting dose of 150 mg/day (75 mg twice daily) escalated, based on efficacy and tolerability, at weekly visits to increase by 150 mg per week. A final dose of 450 mg/day (225 mg twice daily).

Pregabalin with tizanidine group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years. 2.Fulfill the 2016 updated American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia.
• Sufficient cognitive function, visual acuity and language skills to complete questionnaires and pain diaries and to participate in telephone communication with study nurses to permit titration of the study drugs.
• Experienced daily pain (≥4/10 on a numerical rating scale) for at least 3 months.

You may not qualify if:

• Presence of a painful condition, including inflammatory rheumatic disease, more than 50% as severe as but distinct from fibromyalgia.
• Women who are pregnant or lactating. 3.Women of childbearing potential not using adequate contraceptives. 4.End-stage kidney or liver disease. 5.Unstable cardiovascular disease (myocardial infarction within the preceding year, unstable angina, or congestive heart failure) or clinically relevant abnormal 12-lead electrocardiogram.
• Any poorly controlled medical condition that, in the opinion of the investigator, would interfere with proper conduct of the trial.
• Severe depression, as determined by a Beck Depression Inventory-II score of 29 or more suicidal ideation, as determined by a Beck Depression Inventory-II item 9 score of 2 or more any current major psychiatric disorder (e.g., schizophrenia, bipolar disorder) that is not well controlled.
• Hypersensitivity to any of the study medications. 9.Any current alcohol or drug abuse or dependence (except nicotine and caffeine).
• Those taking more than 90 mg morphine equivalents per day.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• Sichuan Provincial People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University in Beijing

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Pregabalin; tizanidine

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Fang Luo

CONTACT

13611326978; 13211326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: January 30, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)