Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
2014년 5월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
63
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Hannover, 독일
- 248.644.49001 Boehringer Ingelheim Investigational Site
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Ulm, 독일
- 248.644.49004 Boehringer Ingelheim Investigational Site
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Florida
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Bradenton, Florida, 미국
- 248.644.0026 Boehringer Ingelheim Investigational Site
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Tampa, Florida, 미국
- 248.644.0025 Boehringer Ingelheim Investigational Site
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Georgia
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Columbus, Georgia, 미국
- 248.644.0006 Boehringer Ingelheim Investigational Site
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Illinois
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Chicago, Illinois, 미국
- 248.644.0012 Boehringer Ingelheim Investigational Site
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Massachusetts
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Cambridge, Massachusetts, 미국
- 248.644.0005 Boehringer Ingelheim Investigational Site
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New York
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Manhasset, New York, 미국
- 248.644.0003 Boehringer Ingelheim Investigational Site
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New York, New York, 미국
- 248.644.0009 Boehringer Ingelheim Investigational Site
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New York, New York, 미국
- 248.644.0018 Boehringer Ingelheim Investigational Site
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Orangeburg, New York, 미국
- 248.644.0013 Boehringer Ingelheim Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, 미국
- 248.644.0029 Boehringer Ingelheim Investigational Site
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Rhode Island
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Providence, Rhode Island, 미국
- 248.644.0010 Boehringer Ingelheim Investigational Site
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Tennessee
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Memphis, Tennessee, 미국
- 248.644.0030 Boehringer Ingelheim Investigational Site
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Texas
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Houston, Texas, 미국
- 248.644.0008 Boehringer Ingelheim Investigational Site
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Virginia
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Norfolk, Virginia, 미국
- 248.644.0023 Boehringer Ingelheim Investigational Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
6년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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다른: Pramipexole
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
기간: baseline 6 weeks
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
기간: baseline 1 week
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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
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baseline 1 week
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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2
기간: baseline and 2 weeks
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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
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baseline and 2 weeks
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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3
기간: baseline and 3 weeks
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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
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baseline and 3 weeks
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Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4
기간: baseline and 4 weeks
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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
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baseline and 4 weeks
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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6
기간: baseline and 6 weeks
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Total Score is a rating of the overall impairment due to motor and phonic tics.
The scale ranges from 0 (None) to 50 (Severe)
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baseline and 6 weeks
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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1
기간: baseline 1 week
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Total Score is a rating of the overall impairment due to motor and phonic tics.
The scale ranges from 0 (None) to 50 (Severe)
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baseline 1 week
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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2
기간: baseline and 2 weeks
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Total Score is a rating of the overall impairment due to motor and phonic tics.
The scale ranges from 0 (None) to 50 (Severe)
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baseline and 2 weeks
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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3
기간: baseline and 3 weeks
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Total Score is a rating of the overall impairment due to motor and phonic tics.
The scale ranges from 0 (None) to 50 (Severe)
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baseline and 3 weeks
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Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4
기간: baseline 4 weeks
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Total Score is a rating of the overall impairment due to motor and phonic tics.
The scale ranges from 0 (None) to 50 (Severe)
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baseline 4 weeks
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Clinical Global Impressions - Improvement at 1 Week
기간: baseline and Week 1
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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.
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baseline and Week 1
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Clinical Global Impressions - Improvement at Week 2
기간: baseline and Week 2
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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.
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baseline and Week 2
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Clinical Global Impressions - Improvement at Week 3
기간: 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.
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baseline and Week 3
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Clinical Global Impressions - Improvement at Week 4
기간: baseline and Week 4
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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.
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baseline and Week 4
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Clinical Global Impressions - Improvement at Week 6
기간: 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
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Clinical Global Impressions - Severity of Illness at Week 1
기간: baseline and Week 1
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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.
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baseline and Week 1
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Clinical Global Impressions - Severity of Illness at Week 2
기간: baseline and Week 2
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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.
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baseline and Week 2
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Clinical Global Impressions - Severity of Illness at Week 3
기간: 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.
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baseline and Week 3
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Clinical Global Impressions - Severity of Illness at Week 4
기간: baseline and Week 4
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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.
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baseline and Week 4
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Clinical Global Impressions - Severity of Illness at Week 6
기간: baseline and Week 6
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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.
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baseline and Week 6
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Patient Global Impression at Week 1
기간: baseline and Week 1
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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).
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baseline and Week 1
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Patient Global Impression at Week 2
기간: baseline and Week 2
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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
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Patient Global Impression at Week 3
기간: 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).
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baseline and Week 3
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Patient Global Impression at Week 4
기간: baseline and Week 4
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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).
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baseline and Week 4
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Patient Global Impression at Week 6
기간: baseline and Week 6
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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).
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baseline and Week 6
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Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.
기간: baseline and Week 6
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baseline and Week 6
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
유용한 링크
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 1월 1일
기본 완료 (실제)
2009년 6월 1일
연구 등록 날짜
최초 제출
2007년 11월 14일
QC 기준을 충족하는 최초 제출
2007년 11월 14일
처음 게시됨 (추정)
2007년 11월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 5월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 5월 7일
마지막으로 확인됨
2014년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .