Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desvenlafaxine | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine | Drug | Desvenlafaxine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wensheng Qu | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
No immediate plans exist for IPD sharing, but controlled access may be considered post-study completion
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
placebo |
|
| Moderate/severe headache days 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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. | during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) |
| Changes in daily life behavioral capabilities | 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). | During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12) |
| D009422 | Nervous System Diseases |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |