Desvenlafaxine for Preventive Treatment of Frequent Migraines

Tongji Hospital

Status: Active, not recruiting

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Desvenlafaxine

Study type: Interventional

Funder types: Other

Identifiers

NCT07385755

20251111migraine

Details and patient eligibility

About

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

Enrollment: 440 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Eligible participants must be males or females aged 18 years or older
2. 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.
3. Obtain the patient's informed consent.

Exclusion criteria

1. Have a history of allergy to Desvenlafaxine, or have used Desvenlafaxine within 4 weeks prior to the start of the treatment period
2. Are currently taking or require concomitant administration of contraindicated medications as stated in the package insert, such as monoamine oxidase inhibitors (MAOIs).
3. 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)
4. 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
5. 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)
6. Meet the diagnostic criteria for chronic migraine and medication overuse (MO); alcohol dependence or substance use
7. 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
8. Female subjects who are trying to conceive, pregnant or breastfeeding, and those not using contraception

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups, including a placebo group

Desvenlafaxine

Experimental group

Treatment:

Drug: Desvenlafaxine

placebo

Placebo Comparator group

Treatment:

Drug: Placebo