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Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care

NCT01701245 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2016-04-25

Study results available
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Summary

Subjects enrolled into this 10 week study will for the first two weeks document the number of cluster headaches and the means of treating (medication) of these attacks. Subjects will then be randomized to into either two groups. The first group is continuing with standard of care and the second group is treatment with the investigational device (GammaCore) for a period of 4 weeks. After this 4 week period, all subjects will treat with the GammaCore for another 4 week period. It is hypothesized the the treatment group will have a reduction in mean cluster headaches per week by 50% compared to the standard of care group.

Conditions

  • Chronic Cluster Headache

Interventions

DEVICE

GammaCore

vagal stimulation

Sponsors & Collaborators

  • ElectroCore INC

    lead INDUSTRY

Principal Investigators

  • Charly Gaul, Dr med · Migräne- und Kopfschmerzklinik Königstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-03-31
Completion
2014-10-31

Countries

  • Belgium
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701245 on ClinicalTrials.gov