Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache

NCT07359248 | Active Not Recruiting

• 1 other identifier: 20251111TTH
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate whether Desvenlafaxine can reduce the frequency and severity of TTH attacks in patients.

Conditions

Tension Type Headache

Outcome Measures

Primary Outcomes (1)

• Days with tension-type headache (TTH) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

  Days with tension-type headache (TTH) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

  During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

Secondary Outcomes (6)

• Total headache index AUC (area under the curve) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

  during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

• Headache severity (VAS 0-10) and duration (hours per day) during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

  during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

• Acute analgesic consumption: number of days and dosage

  during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

• Treatment effectiveness criterion: reduction in headache days by ≥50% during the third 4-week intervention period compared to the screening period

  during the third 4-week intervention period

• Safety assessment and tolerability evaluation

  During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

Study Arms (2)

Desvenlafaxine

EXPERIMENTAL

Participants in this arm will receive oral Desvenlafaxine at a fixed dose of 50 mg once daily for 12 weeks.

Drug: Desvenlafaxine

placebo

PLACEBO COMPARATOR

Participants in this arm will receive an identical-appearing placebo tablet administered orally once daily for 12 weeks.

Drug: Placebo

Interventions

Desvenlafaxine DRUG

Desvenlafaxine

Desvenlafaxine

Placebo DRUG

Placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18-65 years
• Meeting the diagnostic criteria for tension-type headache (TTH) according to ICHD-3; with ≥6 but \<15 attack days per month in the past 3 months and MIDAS score \>21; onset of TTH before age 50, with a history exceeding 1 year
• Informed consent obtained from the patient

You may not qualify if:

• History of allergy to Desvenlafaxine, or use of Desvenlafaxine within 4 weeks prior to the start of the treatment period; currently taking or requiring concomitant administration of drugs contraindicated in the package insert, such as monoamine oxidase inhibitors (MAOIs);
• Diagnosable with chronic tension-type headache or medication overuse headache;
• Comorbid with other types of headaches, such as trigeminal autonomic cephalalgias, migraine attacks \>1 time/month within 3 months, or secondary headaches (e.g., those caused by intracranial infections, craniocerebral trauma, cerebrovascular diseases);
• Severe psychiatric disorders such as schizophrenia, moderate to severe anxiety-depression (Hamilton scale ≥12 points); poorly controlled epilepsy, cognitive impairments, and other chronic pain conditions; serious organic diseases that pose significant health risks, including uncontrolled hypertension, cardiac disease, hepatic dysfunction, renal insufficiency, infections; any medical condition or prior surgery likely to affect the absorption, metabolism, or excretion of the study drug;
• Concomitant use of venlafaxine analogues such as serotonin-norepinephrine reuptake inhibitors (SNRIs); unstable use of other preventive medications for TTH, including amitriptyline, mirtazapine (≤3 months); discontinuation of currently reported effective prophylactic drugs or overused analgesics for ≥3 months may allow re-enrollment;
• Alcohol dependence or substance abuse;
• Inability to comprehend the study protocol due to low education level, impaired verbal/language function, visual or auditory deficits; failure to accurately complete research materials like headache diaries or cooperate with scale assessments;
• Women who are planning pregnancy, pregnant, breastfeeding, or not using contraception;
• Participation in other interventional clinical studies that may influence outcome evaluations.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Tension-Type Headache

Interventions

Desvenlafaxine Succinate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Lipids

Study Officials

• Wensheng Qu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)