MigrainePhase 1NCT02645370
Efficacy and Safety of Danzhen
A Phase 1 study testing Danzhen and Topiramate in people with Migraine, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Migraine
- What is being tested?
- Danzhen and Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,300 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than or equal to 18 years and less than 70 years.
- The diagnosis of migraine is made according to 2004 The International Classification of Headache Disorders: 2nd edition (ICHD-II) .
- Consent form signed by the participant or his/her authorized surrogate.
Who cannot join
- Patients had primary or secondary headache disorders other than migraine.
- Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control.
- Patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue.
- Patients used other preventive pharmacological agents during the 1 month prior to baseline period.
Trial locations and contacts
1 site in 1 country.
Yajie Wang, MM contact
Gang Zhao, MD contact
About this study
Official title: Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.
Read the detailed description
In adults between 18- and 65-years in China,the prevalence of migraine is 9.3% in general. Migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.The disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of Danzhen for the prophylaxis of migraine in a "real-world"setting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.
- Conditions
- Migraine
- Being tested
- Danzhen, Topiramate
- Keywords
- Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DanzhenDrug
TopiramateDrug
Also called TPM
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator:Topiramate | Active comparator | The treatment with TPM is initiated at a 50 mg daily dose and sequentially increase every 7 days, as tolerated, in 25 mg increments up to a target dose of 150 mg total/day. Receives: Drug: Topiramate |
| Experimental:Danzhen | Experimental | The treatment with Danzhen is 3 tablets triple daily. Receives: Drug: Danzhen |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.
Measured: at baseline phase/the third treatment month of maintenance phase
Secondary outcomes (6)
The decrease of disability days of migraine/month
Measured: at baseline phase/the third treatment month of maintenance phase
The decrease of numbers of rescue medication doses used/month
Measured: at baseline phase/the third treatment month of maintenance phase
A 30% or greater reduction in headache time
Measured: at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects
Measured: at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores
Measured: at the third treatment month of maintenance phase
Compliance
Measured: at the third treatment month of maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017 (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 Xijing 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ecion Pharmaceutical CO..LTD
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, MD, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645370
- Sponsor's protocol ID
- Xijing-APP-CER
- Status last verified
- Dec 2015
- First submitted
- 30 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Danzhen in the Preventive Treatment of Migraine:A Prospective "Real-World" Study.
- ClinicalTrials.gov ID
- NCT02645370
- Acronym / sponsor ID
- Xijing-APP-CER
- Conditions
- Migraine
- Keywords
- Migraine, Danzhen, Topiramate, Headache diary APP, preventive treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Ecion Pharmaceutical CO..LTD
- Study start
- Feb 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- 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.
The purpose is to evaluate the effectiveness and safety profile of Danzhen for the prophylaxis of migraine in a "real-world" setting.
Detailed description
In adults between 18- and 65-years in China,the prevalence of migraine is 9.3% in general. Migraine is a heterogeneous condition that may produce a range of symptom profiles and various degrees of disability.The disability resulting from migraine can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using topiramate as the control, is to evaluate the effectiveness and safety of Danzhen for the prophylaxis of migraine in a "real-world"setting.Patients are asked to maintain a detailed headache diary via headache diary APP throughout the treatment period.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator:Topiramate | Active comparator | Drug: TopiramateThe treatment with TPM is initiated at a 50 mg daily dose and sequentially increase every 7 days, as tolerated, in 25 mg increments up to a target dose of 150 mg total/day. |
| Experimental:Danzhen | Experimental | Drug: DanzhenThe treatment with Danzhen is 3 tablets triple daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than or equal to 18 years and less than 70 years.
- The diagnosis of migraine is made according to 2004 The International Classification of Headache Disorders: 2nd edition (ICHD-II) .
- Consent form signed by the participant or his/her authorized surrogate.
Key exclusion criteria (4 listed)
- Patients had primary or secondary headache disorders other than migraine.
- Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning apregnancy in the next year or if they were not using an adequate form of birth control.
- Patients will be excluded if they had significant medical or psychiatric disease,or taking another antidepressant for any reason and not able to discontinue.
- Patients used other preventive pharmacological agents during the 1 month prior to baseline period.
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 |
|---|---|---|
| Danzhen | Drug | Experimental:Danzhen |
| TopiramateAlso: TPM | Drug | Active Comparator:Topiramate |
Primary outcome
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs.
Time frame: at baseline phase/the third treatment month of maintenance phase
6 secondary outcomes
The decrease of disability days of migraine/month
Time frame: at baseline phase/the third treatment month of maintenance phase
The decrease of numbers of rescue medication doses used/month
Time frame: at baseline phase/the third treatment month of maintenance phase
A 30% or greater reduction in headache time
Time frame: at baseline phase/the third treatment month of maintenance phase
The percentage of discontinued the drug because of side effects
Time frame: at the third treatment month of maintenance phase
Beck Depression Inventory (BDI) scores
Time frame: at the third treatment month of maintenance phase
Compliance
Time frame: at the third treatment month of maintenance phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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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.
Yajie Wang, MM contact
Gang Zhao, MD contact
Gang Zhao, MD study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Danzhen and Topiramate in people with Migraine, run by Xijing 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 4 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: status not confirmed, as of the sponsor's last update on 1 Jan 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yajie Wang, MM (944759069@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A 50% or greater reduction in headache days/month during the third treatment month of maintenance phase relative to baseline phase with one of the study drugs. (time frame: at baseline phase/the third treatment month of maintenance phase). 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 1 Jan 2016.