Tourette's SyndromeNCT00282139
Aripiprazole in the Treatment of Tourette's Syndrome
A study testing Aripiprazole in people with Tourette's Syndrome, run by University of Florida at 1 site in United States.
Trial summary
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Tourette's Syndrome
- What is being tested?
- Aripiprazole
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Oct 2006
- Phase
- Interventional
- 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 6 to 17 years
- All sexes
- Child
Who may be able to join
- DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder;
- "Moderate" severity as reflected on the CGI or the YGTSS;
- Normal ECG; and,
- Written informed consent/assent.
Who cannot join
- Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence);
- Subjects who are pregnant or nursing women;
- Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold;
- Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified;
- Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months);
- Subjects with known allergy or hypersensitivity to aripiprazole;
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- Subjects who have any depot neuroleptic within one treatment cycle or any other changes in psychoactive medications (with the exception of antidepressants) in one month and two months for antidepressants prior to study entry for first administration of study medication;
- Subjects who have clinically significant abnormalities based on physical examination, medical history, ECG, or laboratory tests; and,
- Subjects on medication that pose drug interaction potential with aripiprazole such as carbamazepine, ketoconazole, paroxetine, and fluoxetine.
Trial locations and contacts
1 site in 1 country.
About this study
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Read the detailed description
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
- Conditions
- Tourette's Syndrome
- Being tested
- Aripiprazole
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AripiprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Global improvement in severity of symptoms (tic behaviors)
Secondary outcomes (1)
Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2006 (estimated)
- Study startJan 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette's SyndromeStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Tanya K Murphy, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00282139
- Sponsor's protocol ID
- TSARIP703 / WIRB #20031378
- Other IDs
- 00040256/00042966
- Status last verified
- Oct 2011
- First submitted
- 23 Jan 2006
- Last updated
- 5 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aripiprazole in the Treatment of Tourette's Syndrome
- ClinicalTrials.gov ID
- NCT00282139
- Acronym / sponsor ID
- TSARIP703 / WIRB #20031378
- Conditions
- Tourette's Syndrome
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 25 Jan 2006 (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.
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Detailed description
This is an open-label, flexible dose study designed to evaluate the safety and efficacy of aripiprazole in TS (or chronic tic disorder) subjects with or without associated OC symptoms and with or without ADHD symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (4 listed)
- DSM-IV primary diagnosis of Tourette's syndrome or chronic tic disorder;
- "Moderate" severity as reflected on the CGI or the YGTSS;
- Normal ECG; and,
- Written informed consent/assent.
Key exclusion criteria (9 listed)
- Female subjects of childbearing potential who are not practicing an effective method of birth control (including abstinence);
- Subjects who are pregnant or nursing women;
- Subjects with known seizure disorder, a history or seizures or with conditions that lower seizure threshold;
- Subjects who currently meet DSM-IV criteria for: Schizophrenia, Schizoaffective Disorder, Delusional Disorder, or Psychotic Disorder Not Otherwise Specified;
- Subjects with a Psychoactive Substance Abuse disorder (within the past 3 months);
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 |
|---|---|---|
| Aripiprazole | Drug | – |
Primary outcome
Global improvement in severity of symptoms (tic behaviors)
1 secondary outcome
Assessment of behavior (improvement and severity) for co-morbid conditions, OCD and/or ADHD
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
Tanya K Murphy, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aripiprazole in people with Tourette's Syndrome, run by University of Florida 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 9 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 5 Oct 2011. 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.
Are results available for this study?
The study was stopped early. 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?
Global improvement in severity of symptoms (tic behaviors). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2011.