Chronic Cluster Headache Clinical Trial
— CCHDOfficial title:
Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache. A Prospective Case Series
Verified date | August 2017 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Atkins diet is a nutritional regimen characterized by ad libitum protein and fat intake, but
carbohydrate restriction. It is followed by millions of people around the word as a
life-style, but in the last years was proposed as a treatment for the epilepsy, by its
capacity to induce the state of ketosis.
Since Authors observed that ketosis could be also useful in migraine, and migraine shares
some pathophysiological features with cluster headache, The aim of the study is to test the
efficacy of Atkins diet in Cluster Headache by an open label one harm observational study.
Status | Completed |
Enrollment | 18 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of CCH (less than 30 consecutive days of attacks remission in the last year) - kept a headache diary for at least 1 month - CH onset before the age of 50 Exclusion Criteria: - over consumption of acute pain-killers (triptan, analgesic, or ergotamine) - pregnancy or lactation - type I diabetes - serious organic or psychiatric disorders that the investigators judged as having the potential to influence the trial evaluation. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Umberto I | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Di Lorenzo C, Coppola G, Sirianni G, Rossi P, Pierelli F. O045. Cluster headache improvement during Ketogenic Diet. J Headache Pain. 2015 Dec;16(Suppl 1):A99. doi: 10.1186/1129-2377-16-S1-A99. Erratum in: J Headache Pain. 2017 Dec;18(1):11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attack frequency | Reduction of at least 50% of number of attacks per month | 3 months |
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