Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Baltimore, Maryland 21287


This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache improvement.

Study summary:

Patients are placed on the diet and followed with various measures for 3 months. If the diet is helpful it is continued. Patients are still being enrolled as of 9/6/06.


Inclusion Criteria: - Ages 12-19 - Minimum 15 headaches/month for at least 3 months - Tried 2 preventative medications previously Exclusion Criteria: - Prior use of the Atkins diet for more than 1 week - Pregnancy - Significant heart or kidney disease - Dangerously underweight - Using acute pain medications more than 11 days in the past month - Medications being changed

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

Atkins Diet for Difficult-to-Control Headaches in Teenagers

Official Title:

Use of the Atkins Diet for Adolescents With Chronic Daily Headache.

Overall Status:


Study Phase:

Phase 1



Minimum Age:

12 Years

Maximum Age:

19 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Johns Hopkins University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Non-Randomized, Endpoint Classificati

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Eric H Kossoff, MD
Principal Investigator
Johns Hopkins University

Study Dates

Start Date:September 2005
Completion Date:June 2009
Completion Type:Actual
Primary Completion Date:June 2009
Primary Completion Type:Actual
Verification Date:June 2009
Last Changed Date:July 1, 2009
First Received Date:September 9, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Quality of life (PedsMIDAS)
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Diet duration
Time Frame:as long as tolerated
Safety Issues:False
Outcome Type:Secondary Outcome
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Modified Atkins diet
Description:15 grams of carbohydrates per day - high fat diet

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Johns Hopkins University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Strahlman RS. Can ketosis help migraine sufferers? A case report. Headache. 2006 Jan;46(1):182. No abstract available.

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

This study is not currently recruiting Study Participants. The form below is not enabled.