Active — Not RecruitingNot Applicable

Desvenlafaxine for Preventive Treatment of Frequent Migraines

China440 participantsStarted 2026-01-01

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

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)

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

Trial details

NCT IDNCT07385755

SponsorTongji Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

View on ClinicalTrials.gov More Migraine trials