Patients With Chronic MigraineNCT01096420
Acupuncture in Chronic Migraine: A Randomized Controlled Trial
A study testing acupuncture and topiramate in people with Patients With Chronic Migraine, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial summary
The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Chronic Migraine
- What is being tested?
- acupuncture and topiramate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Aug 2010
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old
- Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.
Who cannot join
- Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .
- The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).
- Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.
- Migraine onset after age 50 or the age at onset of CM > 60 years.
- History of hepatic disorder, nephrolithiasis or other severe illness.
- Cognitive impairment interfering with the subject's ability to follow instructions and describe symptoms.
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- Prior fearful experience of acupuncture.
- Bleeding diathesis or anticoagulation.
- Pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).
Read the detailed description
Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.
Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.
Written informed consent was obtained from all participants before entering the study.
- Conditions
- Patients With Chronic Migraine
- Being tested
- acupuncture, topiramate
- Keywords
- chronic migraine, acupuncture, Topiramate, Randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.
Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).
Sterile disposable and steel needle (3210) were used .
The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi.
topiramateDrug
The patients were submitted to the topiramate treatment also for 12 consecutive weeks.
The study phase consists of a 4-week titration and a 8-week maintenance period.
All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).
Study drug was administered daily in equally divided twice daily doses.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture | Experimental | Not described Receives: Procedure: acupuncture |
| topiramate | Active comparator | Not described Receives: Drug: topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean monthly number of headache days with moderate or severe intensity
a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot.
Measured: 3 months
Secondary outcomes (7)
≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity
Measured: 3 months
Mean monthly total headache days
Measured: 3 months
Reduction from baseline in the use of acute headache medications
Measured: 3 months
Short-Form 36-Item Health Survey(SF-36)
Measured: 3 months
Beck Depression Inventory(BDI)
Measured: 3 months
Migraine disability assessment questionnaire (MIDAS)
Measured: 3 months
Plasma CGRP level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients With Chronic MigraineStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chun-pai Yang, Kuang Tien General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096420
- Sponsor's protocol ID
- 9713
- Status last verified
- Aug 2013
- First submitted
- 29 Mar 2010
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21.
PubMed 22019576
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Chronic Migraine: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01096420
- Acronym / sponsor ID
- 9713
- Conditions
- Patients With Chronic Migraine
- Keywords
- chronic migraine, acupuncture, Topiramate, Randomized trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Mar 2010 (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 aim of this study was to investigate the efficacy and tolerance of acupuncture treatment compared with pharmacologic treatment in patients with chronic migraines.Besides, the investigators tested whether the clinical effects of acupuncture in chronic migraine prophylaxis are mediated by changes of the plasma CGRP (Calcitonin gene-related peptide).
Detailed description
Subjects who completed the prospective baseline periods and meet met the prespecified entry criteria will be randomized into 2 groups: acupuncture treatment, and topiramate treatment group.
Subjects will be allowed to continue taking acute migraine medications for the treatment of breakthrough attacks during the trial, but any migraine preventive medications will be prohibited.
Written informed consent was obtained from all participants before entering the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acupuncture | Experimental | Procedure: acupuncture |
| topiramate | Active comparator | Drug: topiramate |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 75 years old
- Patients were required to have a diagnosis of chronic migraine with or without medication overuse that satisfied the ICHD-2 criteria during the last 3 months prior to trial entry, with an established migraine history for at least 1 year.
Key exclusion criteria (9 listed)
- Patients did not fulfill the criteria of ≧ 15 days or response to triptans or ergots on at least 8 days in prospective baseline periods .
- The presence of headaches other than chronic migraine (such as another primary chronic headache or any secondary headache).
- Migraine prophylaxis agents during last 3 months including β-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents or cycle-modulating hormonal drugs.
- Migraine onset after age 50 or the age at onset of CM > 60 years.
- History of hepatic disorder, nephrolithiasis or other severe illness.
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 |
|---|---|---|
| acupunctureEach patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions. Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week). Sterile disposable and steel needle (3210) were used . The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi. | Procedure or surgery | acupuncture |
| topiramateThe patients were submitted to the topiramate treatment also for 12 consecutive weeks. The study phase consists of a 4-week titration and a 8-week maintenance period. All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose). Study drug was administered daily in equally divided twice daily doses. | Drug | topiramate |
Primary outcome
Mean monthly number of headache days with moderate or severe intensity
Time frame: 3 months
a day with headache pain that lasts ≧ 4 h with peak severity of moderate or severe intensity, or any severity or duration if the subject takes and response to a triptan or ergot.
7 secondary outcomes
≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity
Time frame: 3 months
Mean monthly total headache days
Time frame: 3 months
Reduction from baseline in the use of acute headache medications
Time frame: 3 months
Short-Form 36-Item Health Survey(SF-36)
Time frame: 3 months
Beck Depression Inventory(BDI)
Time frame: 3 months
Migraine disability assessment questionnaire (MIDAS)
Time frame: 3 months
Plasma CGRP level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Derived from this study: PubMed 22019576Yang CP, Chang MH, Liu PE, Li TC, Hsieh CL, Hwang KL, Chang HH. Acupuncture versus topiramate in chronic migraine prophylaxis: a randomized clinical trial. Cephalalgia. 2011 Nov;31(15):1510-21. doi: 10.1177/0333102411420585. Epub 2011 Oct 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and topiramate in people with Patients With Chronic Migraine, run by Kuang Tien 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 14 Aug 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean monthly number of headache days with moderate or severe intensity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096420, which also lists 1 linked publication.
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 14 Aug 2013.