MigraineNCT07385755
Desvenlafaxine for Preventive Treatment of Frequent Migraines
A study testing Desvenlafaxine in people with Migraine, run by Tongji Hospital at 1 site in China.
Trial summary
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Desvenlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
About this study
Official title: Efficacy of Desvenlafaxine in the Preventive Treatment of Frequent Migraines -- Multicenter, Prospective, Randomized, Controlled Study
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
- Conditions
- Migraine
- Being tested
- Desvenlafaxine, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesvenlafaxineDrug
Desvenlafaxine
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Desvenlafaxine | Experimental | Not described Receives: Drug: Desvenlafaxine |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
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)
Measured: 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)
Moderate/severe headache days during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wensheng Qu, Tongji Hospital
- Investigators
- Wensheng Qu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385755
- Sponsor's protocol ID
- 20251111migraine
- Status last verified
- Nov 2025
- First submitted
- 13 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No immediate plans exist for IPD sharing, but controlled access may be considered post-study completion
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Desvenlafaxine in the Preventive Treatment of Frequent Migraines -- Multicenter, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07385755
- Acronym / sponsor ID
- 20251111migraine
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate whether Desvenlafaxine can reduce the frequency and severity of migraine attacks in patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desvenlafaxine | Experimental | Drug: Desvenlafaxine |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesvenlafaxineDesvenlafaxine | Drug | Desvenlafaxine |
| Placeboplacebo | Drug | placebo |
Primary outcome
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)
Time frame: 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)
7 secondary outcomes
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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: During the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No. No immediate plans exist for IPD sharing, but controlled access may be considered post-study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wensheng Qu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desvenlafaxine in people with Migraine, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: during the 12-week intervention period (reported in 4-week intervals: Weeks 0-4, 5-8, and 9-12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.