Migraine Clinical Trial
Official title:
Study for Documentation of the Influence of a Specific Dietary Supplement Treatment of Migraine in Children and Adolescents
Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Status | Recruiting |
Enrollment | 76 |
Est. completion date | April 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Years to 17 Years |
Eligibility |
Inclusion Criteria: - at least 3 days of migraine per month Exclusion Criteria: - not able to communicate in german or english language - any disease that forbids the participation in the trial according to the investigators assessment - pregnancy - no willingness to participate in the trial - known allergy to fish or soya |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universiätsklinikum Essen Neurologische Klinik, Westdeutsches Kopfschmerzzentrum, Hufelandstr.26, | Essen | Nordrhein-Westfalen |
Germany | Migräne und Kopfschmerzklinik Königstein | Königstein Im Taunus |
Lead Sponsor | Collaborator |
---|---|
Complen Health GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of days with headache before and after 12 weeks of daily treatment with a migraine specific dietary supplement | headaches before and after 12 weeks of treatment | No | |
Secondary | frequency, duration and intensity of the migraine | before and after 12 weeks of treatment | Yes |
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