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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00952601
Other study ID # AtkinsTourette
Secondary ID
Status Terminated
Phase Phase 1
First received August 3, 2009
Last updated July 14, 2010
Start date September 2008
Est. completion date July 2010

Study information

Verified date July 2010
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Pharmacotherapy has long been considered the primary approach for tic suppression in Tourette syndrome (TS). Unfortunately, medications are often ineffective and frequently have significant side-effects. This is a pilot therapeutic study using a dietary approach, the modified Atkins diet (MAD). The goal of this study is to establish the safety, tolerability, and efficacy of dietary therapy in patients with TS ("proof of concept") and to determine whether this intervention is worthy of evaluation in large-scale clinical trials. The modified Atkins diet mimics the well established ketogenic diet, but in a less-restrictive dietary manner. Dietary approaches using the MAD/ketogenic diet are currently under investigation for neurological conditions other than epilepsy, including Alzheimer disease, headaches, autism, narcolepsy, brain tumors, traumatic brain injury, Parkinson's disease, and depression.


Recruitment information / eligibility

Status Terminated
Enrollment 20
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 65 Years
Eligibility Inclusion Criteria:

- Ages 12-65 years

- Tourette syndrome (vocal and motor tics for over a year)

- > 20 score on the Yale Global Tic Severity Scale

- Ability to follow instructions and comply with the dietary changes

Exclusion Criteria:

- Secondary tics

- Underweight (BMI < 5%)

- Prior use of the Atkins diet for over 2 days

- High cholesterol or triglycerides

- Major depression or anxiety disorder

- Pregnancy

- Substance abuse

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Modified Atkins diet
Low carbohydrate diet

Locations

Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Tic frequency Number of tics per day, intensity, severity, will be compared to baseline (pre-diet) 2 months No
Secondary Ketosis 2 months No
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