Tourette Syndrome
Conditions
Brief 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. The primary efficacy measure will be the Total Tic Score (TTS) of the Yale Global Tic Severity Scale (YGTSS) at 6 weeks.
Interventions
DRUGpramipexole immediate release (IR)
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions - Severity of Illness at Week 3 | baseline and 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. |
| Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 | baseline 1 week | 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 Tic Score of the Yale Global Tic Severity Scale at Week 2 | baseline and 2 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 |
| Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3 | baseline and 3 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 |
| Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4 | baseline and 4 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 |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6 | baseline and 6 weeks | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1 | baseline 1 week | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2 | baseline and 2 weeks | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3 | baseline and 3 weeks | Total Score is a rating of the overall impairment due to motor and phonic tics. The scale ranges from 0 (None) to 50 (Severe) |
| Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4 | baseline 4 weeks | 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 - Improvement at 1 Week | baseline and Week 1 | 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 at Week 2 | baseline and 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. |
| Clinical Global Impressions - Severity of Illness at Week 2 | baseline and 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. |
| Clinical Global Impressions - Improvement at Week 4 | baseline and 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. |
| Clinical Global Impressions - Improvement at Week 6 | baseline and 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. |
| Clinical Global Impressions - Severity of Illness at Week 1 | baseline and 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. |
| Clinical Global Impressions - Severity of Illness at Week 4 | baseline and 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. |
| Clinical Global Impressions - Severity of Illness at Week 6 | baseline and 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. |
| Patient Global Impression at Week 1 | baseline and 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). |
| Patient Global Impression at Week 2 | baseline and 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). |
| Patient Global Impression at Week 3 | baseline and 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). |
| Patient Global Impression at Week 4 | baseline and 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). |
| Patient Global Impression at Week 6 | baseline and 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). |
| Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | baseline and Week 6 | — |
| Clinical Global Impressions - Improvement at Week 3 | baseline and 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. |
Countries
Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablets matching the Pramipexole tablets to be taken per os | 20 |
| Pramipexole Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid. | 43 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Patient moving out of state | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Pramipexole | Total |
|---|---|---|---|
| Age, Continuous | 11.1 Years STANDARD_DEVIATION 3.2 | 12.2 Years STANDARD_DEVIATION 2.4 | 11.8 Years STANDARD_DEVIATION 2.7 |
| Attention Deficit Hyperactive Disorder Intermediate | 3 Number of Patients | 6 Number of Patients | 9 Number of Patients |
| Attention Deficit Hyperactive Disorder Negative | 9 Number of Patients | 22 Number of Patients | 31 Number of Patients |
| Attention Deficit Hyperactive Disorder Positive | 8 Number of Patients | 15 Number of Patients | 23 Number of Patients |
| Body Mass Index | 20.085 kilograms/(meters squared) STANDARD_DEVIATION 5.324 | 22.575 kilograms/(meters squared) STANDARD_DEVIATION 5.656 | 21.784 kilograms/(meters squared) STANDARD_DEVIATION 5.632 |
| Duration of Tourettes syndrome 1-5 years | 10 participants | 19 participants | 29 participants |
| Duration of Tourettes syndrome Less than 1 years | 6 participants | 12 participants | 18 participants |
| Duration of Tourettes syndrome More than 5 years | 4 participants | 12 participants | 16 participants |
| Ethnicity, Customized Hispanic/Latino | 2 Number of Patients | 5 Number of Patients | 7 Number of Patients |
| Ethnicity, Customized Not Hispanic/Latino | 18 Number of Patients | 38 Number of Patients | 56 Number of Patients |
| Height | 150.7 centimeters STANDARD_DEVIATION 21.6 | 155.3 centimeters STANDARD_DEVIATION 16.2 | 153.8 centimeters STANDARD_DEVIATION 18 |
| Obsessive Compulsive Disorder Intermediate | 1 participants | 3 participants | 4 participants |
| Obsessive Compulsive Disorder Negative | 16 participants | 37 participants | 53 participants |
| Obsessive Compulsive Disorder Positive | 3 participants | 3 participants | 6 participants |
| Race, Customized Black/African American | 2 participants | 4 participants | 6 participants |
| Race, Customized White | 18 participants | 39 participants | 57 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 10 Participants |
| Sex: Female, Male Male | 18 Participants | 35 Participants | 53 Participants |
| Weight | 47.48 kilograms STANDARD_DEVIATION 21.29 | 55.87 kilograms STANDARD_DEVIATION 20.64 | 53.21 kilograms STANDARD_DEVIATION 21.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 20 | 25 / 43 |
| serious Total, serious adverse events | 1 / 20 | 0 / 43 |
Outcome results
Primary
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.
Time frame: baseline 6 weeks
Population: The Full Analysis Set (FAS) with last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale | -7.17 score on a scale | Standard Error 2.02 |
| Pramipexole | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale | -7.16 score on a scale | Standard Error 1.38 |
p-value: 0.99695% CI: [-4.95, 4.97]ANCOVA
Secondary
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.
Time frame: baseline and Week 1
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Improvement at 1 Week | Not Responder | 20 Number of Patients |
| Placebo | Clinical Global Impressions - Improvement at 1 Week | Responder | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at 1 Week | Responder | 5 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at 1 Week | Not Responder | 37 Number of Patients |
p-value: 0.1052Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 2
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Improvement at Week 2 | Responder | 1 Number of Patients |
| Placebo | Clinical Global Impressions - Improvement at Week 2 | Not Responder | 19 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 2 | Responder | 6 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 2 | Not Responder | 36 Number of Patients |
p-value: 0.2274Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 3
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Improvement at Week 3 | Not Responder | 18 Number of Patients |
| Placebo | Clinical Global Impressions - Improvement at Week 3 | Responder | 2 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 3 | Not Responder | 37 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 3 | Responder | 5 Number of Patients |
p-value: 0.7691Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 4
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Improvement at Week 4 | Responder | 7 Number of Patients |
| Placebo | Clinical Global Impressions - Improvement at Week 4 | Not Responder | 13 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 4 | Responder | 6 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 4 | Not Responder | 36 Number of Patients |
p-value: 0.0674Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 6
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Improvement at Week 6 | Responder | 7 Number of Patients |
| Placebo | Clinical Global Impressions - Improvement at Week 6 | Not Responder | 13 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 6 | Responder | 11 Number of Patients |
| Pramipexole | Clinical Global Impressions - Improvement at Week 6 | Not Responder | 31 Number of Patients |
p-value: 0.4944Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 1
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Severity of Illness at Week 1 | Improved | 0 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 1 | Worsened | 0 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 1 | Unchanged | 20 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 1 | Worsened | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 1 | Improved | 4 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 1 | Unchanged | 38 Number of Patients |
p-value: 0.162Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 2
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Severity of Illness at Week 2 | Improved | 1 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 2 | Unchanged | 19 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 2 | Worsened | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 2 | Improved | 4 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 2 | Unchanged | 37 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 2 | Worsened | 1 Number of Patients |
p-value: 0.6375Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 3
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Severity of Illness at Week 3 | Improved | 3 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 3 | Unchanged | 17 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 3 | Worsened | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 3 | Improved | 4 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 3 | Unchanged | 37 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 3 | Worsened | 1 Number of Patients |
p-value: 0.6625Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 4
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Severity of Illness at Week 4 | Unchanged | 16 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 4 | Worsened | 0 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 4 | Improved | 4 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 4 | Unchanged | 38 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 4 | Worsened | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 4 | Improved | 4 Number of Patients |
p-value: 0.2664Cochran-Mantel-Haenszel
Secondary
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.
Time frame: baseline and Week 6
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinical Global Impressions - Severity of Illness at Week 6 | Improved | 4 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 6 | Unchanged | 16 Number of Patients |
| Placebo | Clinical Global Impressions - Severity of Illness at Week 6 | Worsened | 0 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 6 | Improved | 10 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 6 | Unchanged | 32 Number of Patients |
| Pramipexole | Clinical Global Impressions - Severity of Illness at Week 6 | Worsened | 0 Number of Patients |
p-value: 0.7302Cochran-Mantel-Haenszel
Secondary
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
Time frame: baseline and Week 6
Population: Full Analysis Set (FAS).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Phosphate - increase | 2 participants |
| Placebo | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Bilirubin, total - increase | 0 participants |
| Placebo | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Tachycardia | 0 participants |
| Placebo | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Orthostatic hypotension | 1 participants |
| Pramipexole | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Orthostatic hypotension | 4 participants |
| Pramipexole | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Phosphate - increase | 5 participants |
| Pramipexole | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Tachycardia | 1 participants |
| Pramipexole | Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry. | Bilirubin, total - increase | 1 participants |
Secondary
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)
Time frame: baseline 1 week
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1 | -6.2 score on a scale | Standard Deviation 13.3 |
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1 | -8.8 score on a scale | Standard Deviation 11.1 |
Secondary
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)
Time frame: baseline and 2 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2 | -9.5 score on a scale | Standard Deviation 16.1 |
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2 | -10.6 score on a scale | Standard Deviation 17.5 |
Secondary
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)
Time frame: baseline and 3 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3 | -14.1 score on a scale | Standard Deviation 17.2 |
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3 | -12.2 score on a scale | Standard Deviation 15.7 |
Secondary
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)
Time frame: baseline 4 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4 | -15.5 score on a scale | Standard Deviation 18.2 |
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4 | -13.9 score on a scale | Standard Deviation 15.7 |
Secondary
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)
Time frame: baseline and 6 weeks
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6 | -15.43 score on a scale | Standard Error 4.44 |
| Pramipexole | Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6 | -15.58 score on a scale | Standard Error 3.03 |
p-value: 0.97895% CI: [-11.05, 10.75]ANCOVA
Secondary
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
Time frame: baseline 1 week
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 | -3.7 score on a scale | Standard Deviation 4.1 |
| Pramipexole | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1 | -4.1 score on a scale | Standard Deviation 5.4 |
95% CI: [-5.81, -2.08]Repeated Measures
Secondary
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
Time frame: baseline and 2 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2 | -5.3 score on a scale | Standard Deviation 7.9 |
| Pramipexole | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2 | -5 score on a scale | Standard Deviation 7.4 |
95% CI: [-7.21, -3.39]Repeated measures
Secondary
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
Time frame: baseline and 3 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3 | -6.2 score on a scale | Standard Deviation 6.3 |
| Pramipexole | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3 | -5.4 score on a scale | Standard Deviation 6.3 |
Secondary
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
Time frame: baseline and 4 weeks
Population: The Full Analysis Set was composed of patients that provided a baseline and a post-baseline assessment in Total Tic Score. A total of 62 patients are included in the Full Analysis Set, 20 placebo patients and 42 pramipexole patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4 | -6 score on a scale | Standard Deviation 7.9 |
| Pramipexole | Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4 | -6.4 score on a scale | Standard Deviation 7.3 |
95% CI: [-7.88, -4.06]Repeated measures
Secondary
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).
Time frame: baseline and Week 1
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression at Week 1 | Responder | 4 Number of Patients |
| Placebo | Patient Global Impression at Week 1 | Not Responder | 16 Number of Patients |
| Pramipexole | Patient Global Impression at Week 1 | Responder | 7 Number of Patients |
| Pramipexole | Patient Global Impression at Week 1 | Not Responder | 35 Number of Patients |
p-value: 0.7723Cochran-Mantel-Haenszel
Secondary
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).
Time frame: baseline and Week 2
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression at Week 2 | Responder | 6 Number of Patients |
| Placebo | Patient Global Impression at Week 2 | Not Responder | 14 Number of Patients |
| Pramipexole | Patient Global Impression at Week 2 | Responder | 9 Number of Patients |
| Pramipexole | Patient Global Impression at Week 2 | Not Responder | 33 Number of Patients |
p-value: 0.4852Cochran-Mantel-Haenszel
Secondary
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).
Time frame: baseline and Week 3
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression at Week 3 | Responder | 5 Number of Patients |
| Placebo | Patient Global Impression at Week 3 | Not Responder | 15 Number of Patients |
| Pramipexole | Patient Global Impression at Week 3 | Responder | 7 Number of Patients |
| Pramipexole | Patient Global Impression at Week 3 | Not Responder | 35 Number of Patients |
p-value: 0.4607Cochran-Mantel-Haenszel
Secondary
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).
Time frame: baseline and Week 4
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression at Week 4 | Responder | 4 Number of Patients |
| Placebo | Patient Global Impression at Week 4 | Not Responder | 16 Number of Patients |
| Pramipexole | Patient Global Impression at Week 4 | Responder | 7 Number of Patients |
| Pramipexole | Patient Global Impression at Week 4 | Not Responder | 35 Number of Patients |
p-value: 0.7723Cochran-Mantel-Haenszel
Secondary
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).
Time frame: baseline and Week 6
Population: The Full Analysis Set with last observation carried forward (LOCF).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Patient Global Impression at Week 6 | Responder | 6 Number of Patients |
| Placebo | Patient Global Impression at Week 6 | Not Responder | 14 Number of Patients |
| Pramipexole | Patient Global Impression at Week 6 | Responder | 12 Number of Patients |
| Pramipexole | Patient Global Impression at Week 6 | Not Responder | 30 Number of Patients |
p-value: 0.9389Cochran-Mantel-Haenszel