Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
2014年5月7日 更新者：Boehringer Ingelheim
A Randomized, Double-blind, Placebo-controlled, Flexible Dose Study to Evaluate Efficacy and Safety of Pramipexole Immediate Release (0.125-0.5mg/Day) Versus Placebo for 6 Weeks in Children and Adolescents (Age 6-17 Inclusive) Diagnosed With Tourette Disorder According to DSM IV Criteria.
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.
調査の概要
研究の種類
介入
入学 (実際)
63
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Bradenton、Florida、アメリカ
- 248.644.0026 Boehringer Ingelheim Investigational Site
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Tampa、Florida、アメリカ
- 248.644.0025 Boehringer Ingelheim Investigational Site
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Georgia
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Columbus、Georgia、アメリカ
- 248.644.0006 Boehringer Ingelheim Investigational Site
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Illinois
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Chicago、Illinois、アメリカ
- 248.644.0012 Boehringer Ingelheim Investigational Site
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Massachusetts
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Cambridge、Massachusetts、アメリカ
- 248.644.0005 Boehringer Ingelheim Investigational Site
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New York
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Manhasset、New York、アメリカ
- 248.644.0003 Boehringer Ingelheim Investigational Site
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New York、New York、アメリカ
- 248.644.0009 Boehringer Ingelheim Investigational Site
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New York、New York、アメリカ
- 248.644.0018 Boehringer Ingelheim Investigational Site
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Orangeburg、New York、アメリカ
- 248.644.0013 Boehringer Ingelheim Investigational Site
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ
- 248.644.0029 Boehringer Ingelheim Investigational Site
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Rhode Island
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Providence、Rhode Island、アメリカ
- 248.644.0010 Boehringer Ingelheim Investigational Site
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Tennessee
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Memphis、Tennessee、アメリカ
- 248.644.0030 Boehringer Ingelheim Investigational Site
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Texas
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Houston、Texas、アメリカ
- 248.644.0008 Boehringer Ingelheim Investigational Site
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Virginia
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Norfolk、Virginia、アメリカ
- 248.644.0023 Boehringer Ingelheim Investigational Site
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Hannover、ドイツ
- 248.644.49001 Boehringer Ingelheim Investigational Site
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Ulm、ドイツ
- 248.644.49004 Boehringer Ingelheim Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6年～17年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：プラセボ
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|
|
他の：Pramipexole
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
時間枠：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. |
baseline 6 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
時間枠：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
|
baseline 1 week
|
|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
時間枠：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
|
baseline and 2 weeks
|
|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
時間枠：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
|
baseline and 3 weeks
|
|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
時間枠：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
|
baseline and 4 weeks
|
|
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
時間枠：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)
|
baseline and 6 weeks
|
|
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
時間枠：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)
|
baseline 1 week
|
|
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
時間枠：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)
|
baseline and 2 weeks
|
|
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
時間枠：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)
|
baseline and 3 weeks
|
|
Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
時間枠：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)
|
baseline 4 weeks
|
|
Clinical Global Impressions - Improvement at 1 Week
時間枠：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.
|
baseline and Week 1
|
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Clinical Global Impressions - Improvement at Week 2
時間枠：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.
|
baseline and Week 2
|
|
Clinical Global Impressions - Improvement at Week 3
時間枠：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.
|
baseline and Week 3
|
|
Clinical Global Impressions - Improvement at Week 4
時間枠：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.
|
baseline and Week 4
|
|
Clinical Global Impressions - Improvement at Week 6
時間枠：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.
|
baseline and Week 6
|
|
Clinical Global Impressions - Severity of Illness at Week 1
時間枠：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.
|
baseline and Week 1
|
|
Clinical Global Impressions - Severity of Illness at Week 2
時間枠：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.
|
baseline and Week 2
|
|
Clinical Global Impressions - Severity of Illness at Week 3
時間枠：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.
|
baseline and Week 3
|
|
Clinical Global Impressions - Severity of Illness at Week 4
時間枠：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.
|
baseline and Week 4
|
|
Clinical Global Impressions - Severity of Illness at Week 6
時間枠：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.
|
baseline and Week 6
|
|
Patient Global Impression at Week 1
時間枠：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).
|
baseline and Week 1
|
|
Patient Global Impression at Week 2
時間枠：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).
|
baseline and Week 2
|
|
Patient Global Impression at Week 3
時間枠：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).
|
baseline and Week 3
|
|
Patient Global Impression at Week 4
時間枠：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).
|
baseline and Week 4
|
|
Patient Global Impression at Week 6
時間枠：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).
|
baseline and Week 6
|
|
Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
時間枠：baseline and Week 6
|
baseline and Week 6
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年1月1日
一次修了 (実際)
2009年6月1日
試験登録日
最初に提出
2007年11月14日
QC基準を満たした最初の提出物
2007年11月14日
最初の投稿 (見積もり)
2007年11月15日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年5月16日
QC基準を満たした最後の更新が送信されました
2014年5月7日
最終確認日
2014年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。