Tourette Syndrome
Conditions
Brief 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) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).
Interventions
DRUGpramipexole 0.125 mg BID
titrated dose for those patients whose symptoms were not controlled on the 0.0625 mg BID dose
DRUGpramipexole 0.0625 mg QD
dose down titrated for those patients unable to tolerate the 0.0625 mg BID dosing
DRUGpramipexole 0.125 mg TID
titrated up for those patients whose symptoms were not adequately controlled on 0.125 mg BID dose
DRUGpramipexole 0.25 mg BID
titrated for those patients whose symptoms were not adequately controlled on 0.125 mg TID dose
DRUGpramipexole 0.0625 mg BID
0.0625 mg BID given for first 4 wks of treatment
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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. 3. Ability and willingness to comply with study treatment regimen and to complete study assessments. 4. Females of childbearing potential having a negative serum pregnancy test at Visit 1. 5. 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
Exclusion criteria
1. Breastfeeding females. 2. Development of any clinical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with pramipexole. 3. 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. 4. 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. 5. 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. 6. 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. 7. History or presence of clinical signs of epilepsy or seizures other than fever-related seizures in early childhood. 8. 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. 9. 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). 10. 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. 11. Allergic response to pramipexole or the inactive ingredients in its tablet formulation. 12. Non-compliance with study medication (defined as less than 80% or more than 120%) during the preceding Study 248.641 or 248.644. 13. Concurrent participation in another clinical trial using any investigational drug since completion of the preceding Study 248.641 or 248.644. 14. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Adverse Events Leading to Discontinuation of Trial Drug | 24 Weeks | Number of patients with Adverse Events leading to discontinuation of trial drug |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | baseline and week 24 | 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. |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | baseline and Week 24 (end of treatment visit) | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe). |
| Clinical Global Impressions - Severity of Illness | week 24 | 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. |
| Clinical Global Impressions - Severity of Illness, Categorized | week 24 | 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. |
| Clinical Global Impressions - Improvement | week 1 | 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). |
| Patient Global Impression - Improvement | 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). |
| Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Baseline and 24 weeks | 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) |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pramipexole 4 weeks individual dose titration starting with 0.0625 mg BID, down-titration to 0.0625 QD if not tolerated, and next steps 0.125 mg BID, 0.125 mg TID and 0.25 mg BID, according to efficacy assessment; established optimal dose for the remainder of the 24-week treatment period. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Other | 18 |
Baseline characteristics
| Characteristic | Pramipexole |
|---|---|
| Age, Continuous | 11.8 Years STANDARD_DEVIATION 2.8 |
| Attention Deficit Hyperactive Disorder Intermediate | 6 participants |
| Attention Deficit Hyperactive Disorder Negative | 22 participants |
| Attention Deficit Hyperactive Disorder Positive | 17 participants |
| Body mass index | 22.064 kilograms/square meter STANDARD_DEVIATION 5.93 |
| Body temperature | 36.752 Degrees centigrade STANDARD_DEVIATION 0.718 |
| Duration of Tourettes Syndrome 1 to 5 years | 20 Participants |
| Duration of Tourettes Syndrome Less than 1 year | 15 Participants |
| Duration of Tourettes Syndrome More than 5 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 152.6 centimeters STANDARD_DEVIATION 19.4 |
| Obsessive Compulsive Disorder Intermediate | 4 Participants |
| Obsessive Compulsive Disorder Negative | 37 Participants |
| Obsessive Compulsive Disorder Positive | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 5 participants |
| Race/Ethnicity, Customized White | 40 participants |
| Respiration | 17.4 breaths/minute STANDARD_DEVIATION 2 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 36 Participants |
| Treatment received in previous trial (NCT00558467) Received placebo | 14 Participants |
| Treatment received in previous trial (NCT00558467) Received pramipexole | 31 Participants |
| Weight | 53.01 kilograms STANDARD_DEVIATION 21.58 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 45 |
| serious Total, serious adverse events | 1 / 45 |
Outcome results
Primary
Patients With Adverse Events Leading to Discontinuation of Trial Drug
Number of patients with Adverse Events leading to discontinuation of trial drug
Time frame: 24 Weeks
Population: Treated set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pramipexole | Patients With Adverse Events Leading to Discontinuation of Trial Drug | 1 participants |
Secondary
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).
Time frame: week 24
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Clinical Global Impressions - Improvement | Responder (Much improved or Very much improved) | 22 participants |
| Pramipexole | Clinical Global Impressions - Improvement | Not Responder | 23 participants |
Secondary
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).
Time frame: week 20
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 16
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 12
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 8
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 4
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 3
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 1
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 2
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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.
Time frame: week 24
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Clinical Global Impressions - Severity of Illness | -1.1 score on a scale | Standard Deviation 1.1 |
Secondary
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.
Time frame: week 24
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Clinical Global Impressions - Severity of Illness, Categorized | Improved (change score <= -2) | 11 participants |
| Pramipexole | Clinical Global Impressions - Severity of Illness, Categorized | Unchanged (change score of -1, 0, or +1) | 31 participants |
| Pramipexole | Clinical Global Impressions - Severity of Illness, Categorized | Worsened (change score >= +2) | 0 participants |
Secondary
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)
Time frame: Baseline and 24 weeks
Population: Observed Cases Treated set (OC TS). All participants in Treated Set having observed data at the particular timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Haemoglobin - decrease | 2 participants |
| Pramipexole | Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Eosinophils - increase | 3 participants |
| Pramipexole | Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Phosphate - increase | 2 participants |
| Pramipexole | Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters | Alkaline phosphatase - increase | 1 participants |
Secondary
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).
Time frame: baseline and Week 2
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -17.4 Score on a scale | Standard Deviation 17.6 |
Secondary
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).
Time frame: baseline and Week 3
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -18.4 Score on a scale | Standard Deviation 19.8 |
Secondary
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).
Time frame: baseline and Week 4
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -20.9 Score on a scale | Standard Deviation 21.5 |
Secondary
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).
Time frame: baseline and Week 8
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -22.4 Score on a scale | Standard Deviation 21.9 |
Secondary
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).
Time frame: baseline and Week 12
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -27.7 Score on a scale | Standard Deviation 20.9 |
Secondary
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).
Time frame: baseline and Week 16
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -28.3 Score on a scale | Standard Deviation 20.2 |
Secondary
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).
Time frame: baseline and Week 20
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -26.7 Score on a scale | Standard Deviation 24.9 |
Secondary
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).
Time frame: baseline and Week 24
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -22.0 Score on a scale | Standard Deviation 23.6 |
Secondary
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).
Time frame: baseline and Week 1
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -14.5 Score on a scale | Standard Deviation 18.2 |
Secondary
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).
Time frame: baseline and Week 24 (end of treatment visit)
Population: The Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale | -22.0 Score on a scale | Standard Deviation 21 |
Secondary
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.
Time frame: baseline and Week 20
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -11.7 Score on a scale | Standard Deviation 11.3 |
Secondary
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.
Time frame: baseline and Week 16
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -12.4 Score on a scale | Standard Deviation 9.3 |
Secondary
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.
Time frame: baseline and Week 12
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -12.3 Score on a scale | Standard Deviation 9 |
Secondary
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.
Time frame: baseline and Week 8
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -10.7 Score on a scale | Standard Deviation 9.4 |
Secondary
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.
Time frame: baseline and week 4
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -9.3 Score on a scale | Standard Deviation 9.7 |
Secondary
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.
Time frame: baseline and Week 3
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -8.6 Score on a scale | Standard Deviation 8.6 |
Secondary
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.
Time frame: baseline and Week 2
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -8.3 Score on a scale | Standard Deviation 7.7 |
Secondary
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.
Time frame: baseline and Week 1
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -7.2 Score on a scale | Standard Deviation 8.5 |
Secondary
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.
Time frame: baseline and week 24
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -9.8 Score on a scale | Standard Deviation 8.9 |
Secondary
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.
Time frame: baseline and Week 24
Population: Observed Cases Full Analysis Set (OC FAS). All participants in FAS having observed data at the particular timepoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pramipexole | Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale | -9.3 Score on a scale | Standard Deviation 10.4 |
Secondary
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).
Time frame: week 2
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 3
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 4
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 8
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 12
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 16
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 20
Population: This outcome measure was not analyzed due to the premature ending of the trial.
Secondary
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).
Time frame: week 24
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pramipexole | Patient Global Impression - Improvement | Responder (Much better or Very much better) | 17 participants |
| Pramipexole | Patient Global Impression - Improvement | Not Responder | 28 participants |
Secondary
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).
Time frame: week 1
Population: This outcome measure was not analyzed due to the premature ending of the trial.