Tourette SyndromePhase 1NCT00952601
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
A Phase 1 study testing Modified Atkins diet in people with Tourette Syndrome, run by Johns Hopkins University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Modified Atkins diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Tourette Syndrome
- Being tested
- Modified Atkins diet
- Keywords
- Tourette, Atkins, Ketosis, Tic
- Medical subject headings
- Tourette Syndrome, Ketosis, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Atkins dietDietary supplement
Low carbohydrate diet
| Study group | Role | What they receive |
|---|---|---|
| Modified Atkins Diet | Experimental | Patients are started on the modified Atkins diet at 15 grams per day. Receives: Dietary Supplement: Modified Atkins diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tic frequency
Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)
Measured: 2 months
Secondary outcomes (1)
Ketosis
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Insufficient interest and recruitment - study ended prematurely by investigators
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952601
- Sponsor's protocol ID
- AtkinsTourette
- Status last verified
- Jul 2010
- First submitted
- 3 Aug 2009
- Last updated
- 15 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19049584
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Modified Atkins Diet for Tourette Syndrome
- ClinicalTrials.gov ID
- NCT00952601
- Acronym / sponsor ID
- AtkinsTourette
- Conditions
- Tourette Syndrome
- Keywords
- Tourette, Atkins, Ketosis, Tic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient interest and recruitment - study ended prematurely by investigators
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Modified Atkins Diet | Experimental | Dietary Supplement: Modified Atkins dietPatients are started on the modified Atkins diet at 15 grams per day. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Secondary tics
- Underweight (BMI < 5%)
- Prior use of the Atkins diet for over 2 days
- High cholesterol or triglycerides
- Major depression or anxiety disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Atkins dietLow carbohydrate diet | Dietary supplement | Modified Atkins Diet |
Primary outcome
Tic frequency
Time frame: 2 months
Number of tics per day, intensity, severity, will be compared to baseline (pre-diet)
1 secondary outcome
Ketosis
Time frame: 2 months
Results and safety
The study was stopped early (reason given: Insufficient interest and recruitment - study ended prematurely by investigators). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2010.
- Background: PubMed 19049584Kossoff EH, Dorward JL. The modified Atkins diet. Epilepsia. 2008 Nov;49 Suppl 8:37-41. doi: 10.1111/j.1528-1167.2008.01831.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Modified Atkins diet in people with Tourette Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient interest and recruitment - study ended prematurely by investigators). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tic frequency (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2010.