NCT01096420

Brief 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 (Calcitonin gene-related peptide).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

March 29, 2010

Last Update Submit

August 12, 2013

Conditions

Patients With Chronic Migraine

Keywords

chronic migraineacupunctureTopiramateRandomized trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (7)

  • ≥ 30% or ≥ 50% reduction in mean monthly headache days with moderate or severe intensity

    3 months

  • Mean monthly total headache days

    3 months

  • Reduction from baseline in the use of acute headache medications

    3 months

  • Short-Form 36-Item Health Survey(SF-36)

    3 months

  • Beck Depression Inventory(BDI)

    3 months

  • +2 more secondary outcomes

Study Arms (2)

acupuncture

EXPERIMENTAL
Procedure: acupuncture

topiramate

ACTIVE COMPARATOR
Drug: topiramate

Interventions

acupuncturePROCEDURE

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.

acupuncture
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.

topiramate

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Prior fearful experience of acupuncture.
  • Bleeding diathesis or anticoagulation.
  • Pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuang Tien General Hospital

Taichung, Taiwan, 433, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 22019576DERIVED

MeSH Terms

Interventions

Acupuncture TherapyTopiramate

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsFructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 31, 2010

Study Start

August 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

TW(1)