Tourette SyndromePhase 2NCT00558467

Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

A Phase 2 study testing pramipexole immediate release (IR) in people with Tourette Syndrome, run by Boehringer Ingelheim at 16 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A randomized, double-blind, placebo-controlled, flexible dose study to evaluate efficacy and safety of Pramipexole versus placebo for 6 weeks in children (age 6-17) diagnosed with Tourette Disorder according to DSM IV criteria. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Tourette Syndrome
What is being tested?: pramipexole immediate release (IR)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 16 sitesin 2 countries
Study dates: Jan 2008to Jun 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Child

Who may be able to join

Male of female patients 6-17 yrs.
Written informed consent.
Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline.
Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children.
Having at least 1 tic/day.
Women of childbearing age must have a negative serum pregnancy test at screening and must use a medically accepted contraceptive method.
Either a newly diagnosed patient or a patient diagnosed with Tourette's Disorder who can safely discontinue treatment.
Having a body weight of > or equal to 20 kg (44 lbs).

Who cannot join

Any women of childbearing age having a positive serum pregnancy test at screening.
Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening.
Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs.
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study.
History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy.
History of/or clinical signs of epilepsy or seizures other than fever related seizures in early childhood.

Show all 17Show fewer

History of/or clinical signs of any malignant neoplasm.
Allergic response to pramipexole.
Had previous treatment with dopamine agonists other than pramipexole within 14 days prior to baseline visit.
Had any other medical treatment for Tourette's Disorder besides the study medication within 28 days prior to baseline visit.
Had withdrawal symptoms of any medication at screening or at the baseline visit.
Having a Kaufman Brief Intelligence Test (KBIT IQ) score <70 at screening.
Having a children's Yale-Brown obsessive-compulsive scale (CY-BOCS) score of >15 at baseline.
Patients who meet criteria for Restless Legs Syndrome and or Periodic Limb Movement disorder.
Patients with severe asthma.
Patients that have initiated psychotherapy for Tourette's Disorder, OCD or ADHD within 3 mths of starting the trial.
Patients receiving psychological, cognitive and/or behavioral treatments greater than 3 mths prior to start of trial for Tourette's Disorder, OCD, and/or ADHD who will have changes in treatment plan.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

United States14 sites

248.644.0026 Boehringer Ingelheim Investigational Site
Bradenton, Florida
248.644.0005 Boehringer Ingelheim Investigational Site
Cambridge, Massachusetts
248.644.0012 Boehringer Ingelheim Investigational Site
Chicago, Illinois
248.644.0006 Boehringer Ingelheim Investigational Site
Columbus, Georgia
248.644.0008 Boehringer Ingelheim Investigational Site
Houston, Texas
248.644.0003 Boehringer Ingelheim Investigational Site
Manhasset, New York
248.644.0030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
248.644.0009 Boehringer Ingelheim Investigational Site
New York, New York
248.644.0018 Boehringer Ingelheim Investigational Site
New York, New York
248.644.0023 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
248.644.0029 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
248.644.0013 Boehringer Ingelheim Investigational Site
Orangeburg, New York
248.644.0010 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
248.644.0025 Boehringer Ingelheim Investigational Site
Tampa, Florida

Other trials in United States

Germany2 sites

248.644.49001 Boehringer Ingelheim Investigational Site
Hanover
248.644.49004 Boehringer Ingelheim Investigational Site
Ulm

Other trials in Germany

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.

Conditions: Tourette Syndrome
Being tested: pramipexole immediate release (IR), Placebo
Medical subject headings: Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pramipexole immediate release (IR)Drug
PlaceboDrug

Study groups in NCT00558467
Study group	Role	What they receive
Pramipexole	Other	Not described Receives: Drug: pramipexole immediate release (IR)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50.
Analysis was adjusted for baseline total tic score and age as linear covariates.
Measured: baseline 6 weeks

Secondary outcomes (25)

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Measured: baseline 1 week
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Measured: baseline and 2 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Measured: baseline and 3 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50
Measured: baseline and 4 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Measured: baseline and 6 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Measured: baseline 1 week
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Measured: baseline and 2 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Measured: baseline and 3 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe)
Measured: baseline 4 weeks
Clinical Global Impressions - Improvement at 1 Week
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Measured: baseline and Week 1
Clinical Global Impressions - Improvement at Week 2
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Measured: baseline and Week 2
Clinical Global Impressions - Improvement at Week 3
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Measured: baseline and Week 3
Clinical Global Impressions - Improvement at Week 4
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Measured: baseline and Week 4
Clinical Global Impressions - Improvement at Week 6
Overall improvement during the last week compared to baseline ranging from 1 (very much improved), 2 (much improved), to 7 (very much worse). Responder has 'very much' or 'much' improvement. Non responder has less improvement than 'much' improvement.
Measured: baseline and Week 6
Clinical Global Impressions - Severity of Illness at Week 1
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Measured: baseline and Week 1
Clinical Global Impressions - Severity of Illness at Week 2
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Measured: baseline and Week 2
Clinical Global Impressions - Severity of Illness at Week 3
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Measured: baseline and Week 3
Clinical Global Impressions - Severity of Illness at Week 4
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Measured: baseline and Week 4
Clinical Global Impressions - Severity of Illness at Week 6
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (the most extremely ill patients). Improved, Unchanged and Worsened responses correspond to changes from baseline of: -2 or less, -1 to +1, and 2 or greater.
Measured: baseline and Week 6
Patient Global Impression at Week 1
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Measured: baseline and Week 1
Patient Global Impression at Week 2
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Measured: baseline and Week 2
Patient Global Impression at Week 3
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Measured: baseline and Week 3
Patient Global Impression at Week 4
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Measured: baseline and Week 4
Patient Global Impression at Week 6
Assessment of the change of the patient's overall condition during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much better) to 7 (very much worse). A responder is defined as having a response of very much (1) or much better (2).
Measured: baseline and Week 6
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
Measured: baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2009

First posted15 Nov 2007 (estimated)
Study startJan 2008
Primary completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tourette SyndromeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558467
Sponsor's protocol ID: 248.644
Status last verified: Mar 2014
First submitted: 14 Nov 2007
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
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Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
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Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Active, not recruiting
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All Tourette Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
ClinicalTrials.gov ID: NCT00558467
Acronym / sponsor ID: 248.644
Conditions: Tourette Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jun 2009 (actual)
First posted: 15 Nov 2007 (estimated)
Results: Posted 20 Oct 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pramipexole	Other	Drug: pramipexole immediate release (IR)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male of female patients 6-17 yrs.
Written informed consent.
Diagnosed with Tourette's Disorder with a > or equal to 22 on the Total Tic Score at baseline.
Diagnosed with Tourette's Disorder when administering the Diagnostic Interview Schedule for Children.
Having at least 1 tic/day.

Key exclusion criteria (17 listed)

Any women of childbearing age having a positive serum pregnancy test at screening.
Patients who have clinically significant renal disease or serum creatinine greater than 1.0 mg/dL at screening.
Lab results at screening: hemoglobin below lower limit of normal which is determined to be clinically significant; Thyroid Stimulating Hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant; clinically significant abnormalities in labs.
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease which would preclude the patient from participating in this study.
History of Schizophrenia or any psychotic disorder, history of mental disorders or any present Axis I psychiatric disorder according to Diagnostic and Statistic Manual of Mental Disorders Fourth Edition (DSM-IV) requiring any medical therapy except for patients with a diagnosis of attention deficit hyperactivity disorder (ADHD) or obsessive-compulsive disorder (OCD) who are not on therapy.

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
pramipexole immediate release (IR)	Drug	Pramipexole
Placebo	Drug	Placebo

Primary outcome

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Time frame: baseline 6 weeks
Total Tic Score is the sum of ten individual ratings of the impairment due to tics. Each scale ranges from 0 (None/Absent) to 5 (Severe) and total score ranges from 0 to 50. Analysis was adjusted for baseline total tic score and age as linear covariates.

25 secondary outcomes

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Time frame: baseline 1 week
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
Time frame: baseline and 2 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
Time frame: baseline and 3 weeks
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
Time frame: baseline and 4 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
Time frame: baseline and 6 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
Time frame: baseline 1 week
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
Time frame: baseline and 2 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
Time frame: baseline and 3 weeks
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
Time frame: baseline 4 weeks
Clinical Global Impressions - Improvement at 1 Week
Time frame: baseline and Week 1
Clinical Global Impressions - Improvement at Week 2
Time frame: baseline and Week 2
Clinical Global Impressions - Improvement at Week 3
Time frame: baseline and Week 3
Clinical Global Impressions - Improvement at Week 4
Time frame: baseline and Week 4
Clinical Global Impressions - Improvement at Week 6
Time frame: baseline and Week 6
Clinical Global Impressions - Severity of Illness at Week 1
Time frame: baseline and Week 1
Clinical Global Impressions - Severity of Illness at Week 2
Time frame: baseline and Week 2
Clinical Global Impressions - Severity of Illness at Week 3
Time frame: baseline and Week 3
Clinical Global Impressions - Severity of Illness at Week 4
Time frame: baseline and Week 4
Clinical Global Impressions - Severity of Illness at Week 6
Time frame: baseline and Week 6
Patient Global Impression at Week 1
Time frame: baseline and Week 1
Patient Global Impression at Week 2
Time frame: baseline and Week 2
Patient Global Impression at Week 3
Time frame: baseline and Week 3
Patient Global Impression at Week 4
Time frame: baseline and Week 4
Patient Global Impression at Week 6
Time frame: baseline and Week 6
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
Time frame: baseline and Week 6

Results and safety

Results posted to the registry on 20 Oct 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	20	19
Pramipexole	43	39

Primary outcome: Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale

Time frame: baseline 6 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Placebo n = 20	Pramipexole n = 42
Value	-7.17 (2.02)	-7.16 (1.38)

Placebo vs Pramipexole: Least Squares mean difference: 0.01 (95% CI -4.95 to 4.97), p = 0.996, ANCOVA

Population analysed: The Full Analysis Set (FAS) with last observation carried forward (LOCF).

25 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events with an onset after the first dose of study medication and up to a period of 48 hours after the last dose of study medication were assigned to the treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 20 (5%)	13 of 20 (65%)	Not reported
Pramipexole	0 of 43 (0%)	25 of 43 (58.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tourette Syndrome

Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
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Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
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Recruiting
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Recruiting
Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Active, not recruiting
Tourette Deep Brain Stimulation (DBS) Target Detection & Suppression
Tourette Syndrome

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pramipexole immediate release (IR) in people with Tourette Syndrome, run by Boehringer Ingelheim at 16 sites in 2 countries.

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 8 inclusion and 17 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: finished, as of the sponsor's last update on 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale (time frame: baseline 6 weeks). 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 NCT00558467.

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 16 May 2014.