Desvenlafaxine for Preventive Treatment of Frequent Migraines

NCT07385755 | Active Not Recruiting

• 1 other identifier: 20251111migraine
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• the change from baseline in monthly migraine days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)

  the change from baseline in monthly migraine days 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 (7)

• Days with migraine every 4 weeks 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)

• Moderate/severe headache days 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)

• The rate of effective responders 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 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)

• Cumulative headache duration 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)

Study Arms (2)

Desvenlafaxine

EXPERIMENTAL

Drug: Desvenlafaxine

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Desvenlafaxine DRUG

Desvenlafaxine

Desvenlafaxine

Placebo DRUG

placebo

placebo

Eligibility Criteria

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

You may qualify if:

• Eligible participants must be males or females aged 18 years or older
• Headache meets the diagnostic criteria for episodic migraine according to ICHD-3; with at least a one-year history of migraines and onset before age 50. During the three months prior to the screening visit (one month defined as four weeks), participants must have experienced≥4 and \<15 episodes of moderate to severe headaches per month, and had at least ≥6 migraine days within a 4-week run-in period.
• Obtain the patient's informed consent.

You may not qualify if:

• Have a history of allergy to Desvenlafaxine, or have used Desvenlafaxine within 4 weeks prior to the start of the treatment period
• Are currently taking or require concomitant administration of contraindicated medications as stated in the package insert, such as monoamine oxidase inhibitors (MAOIs).
• Comorbid with other types of headaches, such as trigeminal autonomic cephalalgias, more than one episode of tension-type headache per month, or secondary headaches (e.g., those caused by intracranial infections, craniocerebral trauma, cerebrovascular diseases)
• Severe psychiatric disorders, such as schizophrenia; poorly controlled epilepsy, cognitive impairments, and other chronic pain conditions; serious concomitant medical illnesses 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 medication
• Use of venlafaxine analogues, such as serotonin-norepinephrine reuptake inhibitors (SNRIs); unstable use of other types of preventive medications for migraine, including calcitonin gene-related peptide (CGRP) antagonists, topiramate, etc. (≥3 months)
• Meet the diagnostic criteria for chronic migraine and medication overuse (MO); alcohol dependence or substance use
• Inability to comprehend the study protocol due to factors including but not limited to low educational attainment, impaired verbal/language function, visual or auditory deficits; failure to accurately complete research documentation (e.g., headache diaries) or incapacity to engage with assessment instruments
• Female subjects who are trying to conceive, pregnant or breastfeeding, and those not using contraception

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

Migraine Disorders

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: January 13, 2026
• First Posted: February 4, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)