Migraine
Conditions
Brief summary
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
Interventions
DRUGDesvenlafaxine
Desvenlafaxine
DRUGPlacebo
placebo
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
| 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) | Moderate/severe headache days 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) | Treatment effectiveness criterion: reduction in headache days by ≥50% 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) | The VAS score reflects the severity of headache pain 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) | Based on the headache diary recordings, the cumulative duration of headache episodes will be summed to calculate the total headache time during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) |
| Change in Anxiety and Depression Scores | during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) | Change from baseline in anxiety and depression levels, assessed by the Hospital Anxiety and Depression Scale (HADS). Total score ranges from 0 to 21 for anxiety and 0 to 21 for depression subscales, where 0-7 = normal, 8-10 = borderline, 11-21 = abnormal. Higher scores indicate worse anxiety/depression. |
| Changes in daily life behavioral capabilities | During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) | The HIT-6 questionnaire measures the adverse impact of headache on daily functioning in six domains (pain, social functioning, role functioning, vitality, cognitive functioning, psychological distress). |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWensheng Qu
Tongji Hospital
Outcome results
None listed