Headache, MigraineNCT06584409
Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP
A study testing Laser Pen and Observation in people with Headache, Migraine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Aims: To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination. Methods: In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Laser Pen and Observation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Apr 2025to 1 Dec 2027
- 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
- Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria.
Who cannot join
- Age under 18 years old
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Taichang, 404
Yuan-Chen Liu, 886-4-2359-2525 ext. 82641
About this study
Official title: The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP: A Single Blind Randomized Sham-laser-acupuncture Controlled Study.
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
Read more
Methods:
In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.
In addition, patients' characteristics will be investigated as follows:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.
Importance:
In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
Read the detailed description
Headache is one of the most common complaints encountered in medical institution as known as an almost universal human experience. Approximately 65% of headaches are classified as primary, which was a composite of migraine, tension-type headache, trigeminal autonomic cephalalgia and other primary headaches according to the third edition of the International Classification of Headache Disorders (ICHD-3). Primary headaches encompass a heterogeneous group of neurologic disorders and might be bothersome for patients.
It's well established that acupuncture can be considered a treatment option for migraine prevention. The efficacy of laser-acupuncture is similar to acupuncture, and laser-acupuncture is a non-invasive therapeutic approach and safety. It could reduce the risk of hemorrhage, infection and needle phobia. However, the efficacy of laser-acupuncture in primary headache remains inconclusive.
MMP2, CGRP, substance P, beta-endorphin are new Lab examination for following up the patients suffered from migraine.
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
Methods:
In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.
In addition, patients' characteristics will be investigated as follows:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.
Importance:
In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
- Conditions
- Headache, Migraine
- Being tested
- Laser Pen, Observation
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser PenDevice
Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)
ObservationOther
Sham treatment with no laser output, stimulate the same acupoints as laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)
After 6 months followed up, the sham group received truely Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3), and followed up for another 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | CM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) Receives: Device: Laser Pen |
| Sham treatment | Sham comparator | CM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cGRP
change in cGRP from baasline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
MMP2
change in MMP2 from baasline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Secondary outcomes (10)
Difference in the number of headache days per month
change in monthly migraine days (MMD) from baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the of headache attacks lasting hours per month
change in acute headache medications usage days per month from baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the headache pain intensity (NRS)
changes in the headache severity (based on NRS) between baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the number of days with acute headache medication intake per month
change in acute headache medications usage days per month from baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the Migraine Disability Assessment
changes in the Migraine Disability Assessmen between baseline and each follow-up time point.
Title: Migraine Disability Assessmen Maximum value:450 Minimum value:0 Higher scores mean: worsen outcome
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the Beck's Depression Inventory
change in Beck's Depression Inventory between baseline and each follow-up time point
Title:Beck's Depression Inventory Maximum value:63 Minimum value:0 Higher scores mean: worsen outcome
Measured: 12 weeks, 24 weeks, 36 weeks
Difference in the Hospital Anxiety and Depression Scale
change in Hospital Anxiety and Depression Scale between baseline and each follow-up time point
Title:Hospital Anxiety and Depression Scale Maximum value:21/21 Minimum value:0/0 Higher scores mean:worsen outcome
Measured: 12 weeks, 24 weeks, 36 weeks
30% reduction in migraine days
≥ 30% reduction in migraine days between baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Substance P
change in Substance P from baasline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
beta-endorphin
change in beta-endorphin from baasline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start7 Apr 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The patients was divided to sham group or laser acupuncture group. After 1 months treatment, and followed up for 6 months., the sham group received complementary laser acupuncture for 1 months and followed up for another 3 months.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Hsiang Chou, M.D., Principal investigator, Taichung Veterans General HospitalChi Sheng Wang, M.D., Study director, Taichung Veterans General HospitalHuan Yun Wu, M.D., Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584409
- Sponsor's protocol ID
- CF24162B
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP: A Single Blind Randomized Sham-laser-acupuncture Controlled Study.
- ClinicalTrials.gov ID
- NCT06584409
- Acronym / sponsor ID
- CF24162B
- Conditions
- Headache, Migraine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 4 Sep 2024 (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.
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
Methods:
In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.
In addition, patients' characteristics will be investigated as follows:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.
Importance:
In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
Detailed description
Headache is one of the most common complaints encountered in medical institution as known as an almost universal human experience. Approximately 65% of headaches are classified as primary, which was a composite of migraine, tension-type headache, trigeminal autonomic cephalalgia and other primary headaches according to the third edition of the International Classification of Headache Disorders (ICHD-3). Primary headaches encompass a heterogeneous group of neurologic disorders and might be bothersome for patients.
It's well established that acupuncture can be considered a treatment option for migraine prevention. The efficacy of laser-acupuncture is similar to acupuncture, and laser-acupuncture is a non-invasive therapeutic approach and safety. It could reduce the risk of hemorrhage, infection and needle phobia. However, the efficacy of laser-acupuncture in primary headache remains inconclusive.
MMP2, CGRP, substance P, beta-endorphin are new Lab examination for following up the patients suffered from migraine.
Aims:
To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination.
Methods:
In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep.
In addition, patients' characteristics will be investigated as follows:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.
Importance:
In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients was divided to sham group or laser acupuncture group. After 1 months treatment, and followed up for 6 months., the sham group received complementary laser acupuncture for 1 months and followed up for another 3 months.
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Laser PenCM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) |
| Sham treatment | Sham comparator | Other: ObservationCM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria.
Key exclusion criteria (2 listed)
- Age under 18 years old
- Pregnancy
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 |
|---|---|---|
| Laser PenLaser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) | Device | Laser treatment |
| ObservationSham treatment with no laser output, stimulate the same acupoints as laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) After 6 months followed up, the sham group received truely Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3), and followed up for another 3 months. | Other | Sham treatment |
Primary outcome
cGRP
Time frame: 12 weeks, 24 weeks, 36 weeks
change in cGRP from baasline and each follow-up time point
MMP2
Time frame: 12 weeks, 24 weeks, 36 weeks
change in MMP2 from baasline and each follow-up time point
10 secondary outcomes
Difference in the number of headache days per month
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the of headache attacks lasting hours per month
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the headache pain intensity (NRS)
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the number of days with acute headache medication intake per month
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the Migraine Disability Assessment
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the Beck's Depression Inventory
Time frame: 12 weeks, 24 weeks, 36 weeks
Difference in the Hospital Anxiety and Depression Scale
Time frame: 12 weeks, 24 weeks, 36 weeks
30% reduction in migraine days
Time frame: 12 weeks, 24 weeks, 36 weeks
Substance P
Time frame: 12 weeks, 24 weeks, 36 weeks
beta-endorphin
Time frame: 12 weeks, 24 weeks, 36 weeks
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 30 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Headache, Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Chi-Hsiang Chou, M.D. principal investigator
Taichung Veterans General Hospital
Chi Sheng Wang, M.D. study director
Taichung Veterans General Hospital
Huan Yun Wu, M.D. study director
Taichung Veterans General 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 Laser Pen and Observation in people with Headache, Migraine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Sep 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 Taiwan. 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?
Contact Yuan-Chen Liu, M.D. (886-972199271, jordan810701@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cGRP (time frame: 12 weeks, 24 weeks, 36 weeks). The study lists 2 primary outcomes in all. 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 30 Sep 2026.