Tourette SyndromePhase 3NCT00681863
Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome
A Phase 3 study testing pramipexole 0.125 mg BID, pramipexole 0.0625 mg QD and pramipexole 0.125 mg TID in people with Tourette Syndrome, run by Boehringer Ingelheim at 14 sites in 2 countries.
Trial summary
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)… 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 0.125 mg BID, pramipexole 0.0625 mg QD and pramipexole 0.125 mg TID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 14 sitesin 2 countries
- Study dates
- May 2008to Oct 2009
- Phase
- Phase 3
- 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 or female patients aged 6-17 years at the time of enrollment into study 248.641 or 248.644 and who have completed study 248.641 or 248.644.
- Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and local Institutional Review Board (IRB) requirements for children obtained prior to any study procedures being performed.
- Ability and willingness to comply with study treatment regimen and to complete study assessments.
- Females of childbearing potential having a negative serum pregnancy test at Visit 1.
- Females of childbearing potential must be using a medically accepted contraceptive method throughout the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives or estrogen patch, double barrier method (spermicide + diaphragm), or abstinence at the discretion of the investigator
Who cannot join
- Breastfeeding females.
- Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole.
- Clinically significant renal disease or serum creatinine out of this range: 0.3 1.0 mg/dL for patients aged 3-12 years and 0.5-1.4 mg/dL for patients aged 13+ years.
- Any of the following lab results at screening:
- Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion) Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion.
- Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, or pulmonary disease (such as severe asthma) in the opinion of the investigator that would preclude the patient from participating in this study.
Show all 15Show fewer
- History or presence of schizophrenia or any psychotic disorder. History or presence of any psychiatric disorder requiring medical therapy with the exception for patients with a diagnosis of Tourette Syndrome (TS), Attention Deficit Hyperactivity Disorder (ADHD) or Obsessive Compulsive Disorder (OCD) who are not on therapy other than pramipexole.
- History or presence of clinical signs of epilepsy or seizures other than fever-related seizures in early childhood.
- History or presence of clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma.
- History of any other medical treatment for TS besides the study medication within 28 days prior to the baseline visit (14 days prior to baseline for guanfacine, 14 days prior to baseline for dopamine agonists, 14 days prior to baseline for L-Dopa, 35 days prior to baseline for fluoxetine).
- Patients receiving psychotherapy are excluded unless they started the treatment at least 3 months prior to starting the trial and no changes in treatment are planned for the duration of the study.
- Allergic response to pramipexole or the inactive ingredients in its tablet formulation.
- Non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding Study 248.641 or 248.644.
- Concurrent participation in another clinical trial using any investigational drug since completion of the preceding Study 248.641 or 248.644.
- Any other conditions, that in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
248.642.0026 Boehringer Ingelheim Investigational Site
Bradenton, Florida
248.642.0005 Boehringer Ingelheim Investigational Site
Cambridge, Massachusetts
248.642.0006 Boehringer Ingelheim Investigational Site
Columbus, Georgia
248.642.0008 Boehringer Ingelheim Investigational Site
Houston, Texas
248.642.0003 Boehringer Ingelheim Investigational Site
Manhasset, New York
248.642.0030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
248.642.0009 Boehringer Ingelheim Investigational Site
New York, New York
248.642.0018 Boehringer Ingelheim Investigational Site
New York, New York
248.642.0023 Boehringer Ingelheim Investigational Site
Norfolk, Virginia
248.642.0029 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
248.642.0013 Boehringer Ingelheim Investigational Site
Orangeburg, New York
248.642.0010 Boehringer Ingelheim Investigational Site
Providence, Rhode Island
248.642.0025 Boehringer Ingelheim Investigational Site
Tampa, Florida
About this study
Official title: Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).
- Conditions
- Tourette Syndrome
- Being tested
- pramipexole 0.125 mg BID, pramipexole 0.0625 mg QD, pramipexole 0.125 mg TID, pramipexole 0.25 mg BID, pramipexole 0.0625 mg BID
- 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 0.125 mg BIDDrug
titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
pramipexole 0.0625 mg QDDrug
dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
pramipexole 0.125 mg TIDDrug
titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
pramipexole 0.25 mg BIDDrug
titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
pramipexole 0.0625 mg BIDDrug
0.0625 mg BID given for first 4 wks of treatment
| Study group | Role | What they receive |
|---|---|---|
| pramipexole 0.0625 mg BID (twice daily) | Active comparator | all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) Receives: Drug: pramipexole 0.0625 mg BID |
| pramipexole 0.0625 mg QD (once daily) | Active comparator | patients to receive one tablet of pramipexole 0.0625 mg QD Receives: Drug: pramipexole 0.0625 mg QD |
| pramipexole 0.125 mg BID | Active comparator | patients to receive one tablet of pramipexole 0.125 mg BID Receives: Drug: pramipexole 0.125 mg BID |
| pramipexole 0.125 mg TID (three times daily) | Active comparator | patients to receive one tablet of pramipexole 0.125 mg TID Receives: Drug: pramipexole 0.125 mg TID |
| pramipexole 0.25 mg BID | Active comparator | patients to receive one tablet of pramipexole 0.25 mg BID Receives: Drug: pramipexole 0.25 mg BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Adverse Events Leading to Discontinuation of Trial Drug
Number of patients with Adverse Events leading to discontinuation of trial drug
Measured: 24 Weeks
Secondary outcomes (40)
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and week 24
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 24 (end of treatment visit)
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 1
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 2
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 3
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and week 4
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 8
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 12
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 16
Mean Change From Baseline in Total Tic Score (TTS) 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.
Measured: baseline and Week 20
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 1
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 2
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 3
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 4
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 8
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 12
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 16
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 20
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
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 Week 24
Clinical Global Impressions - Severity of Illness
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: week 24
Clinical Global Impressions - Severity of Illness, Categorized
Assessment of the overall severity of illness on a scale ranging from 1 (not at all ill) to 7 (among the most extremely ill patients).
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: week 24
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 1
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 2
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 3
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 4
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 8
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 12
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 16
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 20
Clinical Global Impressions - Improvement
Assessment of the overall improvement during the last week compared to the patient's condition at baseline on a scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: week 24
Patient Global Impression - Improvement
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: week 1
Patient Global Impression - Improvement
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: week 2
Patient Global Impression - Improvement
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: week 3
Patient Global Impression - Improvement
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: week 4
Patient Global Impression - Improvement
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: week 8
Patient Global Impression - Improvement
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: week 12
Patient Global Impression - Improvement
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: week 16
Patient Global Impression - Improvement
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: week 20
Patient Global Impression - Improvement
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: week 24
Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
Frequency of patients with possible clinically significant abnormalities for laboratory parameters (blood hematology and electrolyte assessments, serum chemistry, including follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol for pubertal female patients, prolactin in all patients, testosterone in pubertal male patients, urine analysis)
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2009
Why it stopped: Terminated for slow enrollment.
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681863
- Sponsor's protocol ID
- 248.642
- Other IDs
- 2008-000342-32, 2008
- Status last verified
- May 2014
- First submitted
- 19 May 2008
- Last updated
- 23 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT00681863
- Acronym / sponsor ID
- 248.642
- Conditions
- Tourette Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for slow enrollment.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 17 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| pramipexole 0.0625 mg BID (twice daily) | Active comparator | Drug: pramipexole 0.0625 mg BIDall patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms) |
| pramipexole 0.0625 mg QD (once daily) | Active comparator | Drug: pramipexole 0.0625 mg QDpatients to receive one tablet of pramipexole 0.0625 mg QD |
| pramipexole 0.125 mg BID | Active comparator | Drug: pramipexole 0.125 mg BIDpatients to receive one tablet of pramipexole 0.125 mg BID |
| pramipexole 0.125 mg TID (three times daily) | Active comparator | Drug: pramipexole 0.125 mg TIDpatients to receive one tablet of pramipexole 0.125 mg TID |
| pramipexole 0.25 mg BID | Active comparator | Drug: pramipexole 0.25 mg BIDpatients to receive one tablet of pramipexole 0.25 mg BID |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female patients aged 6-17 years at the time of enrollment into study 248.641 or 248.644 and who have completed study 248.641 or 248.644.
- Written informed consent provided by the patient's parent (or legal guardian) and assent provided by the patient consistent with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) and local Institutional Review Board (IRB) requirements for children obtained prior to any study procedures being performed.
- Ability and willingness to comply with study treatment regimen and to complete study assessments.
- Females of childbearing potential having a negative serum pregnancy test at Visit 1.
- Females of childbearing potential must be using a medically accepted contraceptive method throughout the study. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, injectable contraceptives or estrogen patch, double barrier method (spermicide + diaphragm), or abstinence at the discretion of the investigator
Key exclusion criteria (15 listed)
- Breastfeeding females.
- Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole.
- Clinically significant renal disease or serum creatinine out of this range: 0.3 1.0 mg/dL for patients aged 3-12 years and 0.5-1.4 mg/dL for patients aged 13+ years.
- Any of the following lab results at screening:
- Hemoglobin (Hgb) below lower limit of normal (LLN) which is determined to be clinically significant Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significant (at the investigator's discretion) out of normal range at screening (if not caused by substitution therapy according the investigator's opinion) Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion.
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 0.125 mg BIDtitrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose | Drug | pramipexole 0.125 mg BID |
| pramipexole 0.0625 mg QDdose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing | Drug | pramipexole 0.0625 mg QD (once daily) |
| pramipexole 0.125 mg TIDtitrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose | Drug | pramipexole 0.125 mg TID (three times daily) |
| pramipexole 0.25 mg BIDtitrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose | Drug | pramipexole 0.25 mg BID |
| pramipexole 0.0625 mg BID0.0625 mg BID given for first 4 wks of treatment | Drug | pramipexole 0.0625 mg BID (twice daily) |
Primary outcome
Patients With Adverse Events Leading to Discontinuation of Trial Drug
Time frame: 24 Weeks
Number of patients with Adverse Events leading to discontinuation of trial drug
40 secondary outcomes
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and week 24
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 24 (end of treatment visit)
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 1
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 2
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 3
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and week 4
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 8
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 12
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 16
Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale
Time frame: baseline and Week 20
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 1
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 2
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 3
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 4
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 8
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 12
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 16
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 20
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale
Time frame: baseline and Week 24
Clinical Global Impressions - Severity of Illness
Time frame: week 24
Clinical Global Impressions - Severity of Illness, Categorized
Time frame: week 24
Clinical Global Impressions - Improvement
Time frame: week 1
Clinical Global Impressions - Improvement
Time frame: week 2
Clinical Global Impressions - Improvement
Time frame: week 3
Clinical Global Impressions - Improvement
Time frame: week 4
Clinical Global Impressions - Improvement
Time frame: week 8
Clinical Global Impressions - Improvement
Time frame: week 12
Clinical Global Impressions - Improvement
Time frame: week 16
Clinical Global Impressions - Improvement
Time frame: week 20
Clinical Global Impressions - Improvement
Time frame: week 24
Patient Global Impression - Improvement
Time frame: week 1
Patient Global Impression - Improvement
Time frame: week 2
Patient Global Impression - Improvement
Time frame: week 3
Patient Global Impression - Improvement
Time frame: week 4
Patient Global Impression - Improvement
Time frame: week 8
Patient Global Impression - Improvement
Time frame: week 12
Patient Global Impression - Improvement
Time frame: week 16
Patient Global Impression - Improvement
Time frame: week 20
Patient Global Impression - Improvement
Time frame: week 24
Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pramipexole 0.125 mg BID, pramipexole 0.0625 mg QD and pramipexole 0.125 mg TID in people with Tourette Syndrome, run by Boehringer Ingelheim at 14 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 5 inclusion and 15 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 23 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 14 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 17 Dec 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?
Patients With Adverse Events Leading to Discontinuation of Trial Drug (time frame: 24 Weeks). 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 23 May 2014.