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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 18 January 2016
Main ID:  NCT02188394
Date of registration: 10/07/2014
Prospective Registration: No
Primary sponsor: César Fernández-de-las-Peñas
Public title: Anesthetic Blockades and Migraine
Scientific title: Effects of Anesthetic Blockades on Pain Modulation in Migraine
Date of first enrolment: July 2014
Target sample size: 36
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02188394
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Spain
Contacts
Name:     Maria Luz Cuadrado, MD; PhD
Address: 
Telephone:
Email:
Affiliation:  Hospital Clinico San Carlos-Universidad Complutense de Madrid
Key inclusion & exclusion criteria

Inclusion Criteria:

- Chronic migraine

Exclusion Criteria:

- Other primary headaches

- Other secondary headaches

- Co-morbid medical diseases



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Chronic Migraine
Pain
Intervention(s)
Drug: Anesthetic blockades with bupivacaine
Drug: Isotonic saline injection
Primary Outcome(s)
Changes in the number of days with moderate/intense migraine [Time Frame: Baseline (1 week before) and 1 week after intervention]
Secondary Outcome(s)
Changes in the number of days with mild/moderate migraine [Time Frame: Baseline (1 week before) and 1 week after intervention]
Changes in the number of symptomatic medication drugs [Time Frame: Baseline (1 week before) and 1 week after intervention]
Changes in pressure pain thresholds [Time Frame: Baseline, 1 hour after and 1 week after intervention]
Secondary ID(s)
HCSC11/263
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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