- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00558467
Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria
7. maj 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
63
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Florida
-
Bradenton, Florida, Forenede Stater
- 248.644.0026 Boehringer Ingelheim Investigational Site
-
Tampa, Florida, Forenede Stater
- 248.644.0025 Boehringer Ingelheim Investigational Site
-
-
Georgia
-
Columbus, Georgia, Forenede Stater
- 248.644.0006 Boehringer Ingelheim Investigational Site
-
-
Illinois
-
Chicago, Illinois, Forenede Stater
- 248.644.0012 Boehringer Ingelheim Investigational Site
-
-
Massachusetts
-
Cambridge, Massachusetts, Forenede Stater
- 248.644.0005 Boehringer Ingelheim Investigational Site
-
-
New York
-
Manhasset, New York, Forenede Stater
- 248.644.0003 Boehringer Ingelheim Investigational Site
-
New York, New York, Forenede Stater
- 248.644.0009 Boehringer Ingelheim Investigational Site
-
New York, New York, Forenede Stater
- 248.644.0018 Boehringer Ingelheim Investigational Site
-
Orangeburg, New York, Forenede Stater
- 248.644.0013 Boehringer Ingelheim Investigational Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forenede Stater
- 248.644.0029 Boehringer Ingelheim Investigational Site
-
-
Rhode Island
-
Providence, Rhode Island, Forenede Stater
- 248.644.0010 Boehringer Ingelheim Investigational Site
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater
- 248.644.0030 Boehringer Ingelheim Investigational Site
-
-
Texas
-
Houston, Texas, Forenede Stater
- 248.644.0008 Boehringer Ingelheim Investigational Site
-
-
Virginia
-
Norfolk, Virginia, Forenede Stater
- 248.644.0023 Boehringer Ingelheim Investigational Site
-
-
-
-
-
Hannover, Tyskland
- 248.644.49001 Boehringer Ingelheim Investigational Site
-
Ulm, Tyskland
- 248.644.49004 Boehringer Ingelheim Investigational Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
|
Andet: Pramipexole
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Clinical Global Impressions - Improvement at Week 2
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: baseline and Week 6
|
baseline and Week 6
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først indsendt
14. november 2007
Først indsendt, der opfyldte QC-kriterier
14. november 2007
Først opslået (Skøn)
15. november 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
16. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. maj 2014
Sidst verificeret
1. marts 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Genetiske sygdomme, medfødte
- Basal Ganglia Sygdomme
- Bevægelsesforstyrrelser
- Neurodegenerative sygdomme
- Heredodegenerative lidelser, nervesystem
- Neuroudviklingsforstyrrelser
- Tic lidelser
- Tourettes syndrom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Beskyttelsesagenter
- Dopaminagonister
- Dopaminmidler
- Antioxidanter
- Antiparkinson-midler
- Midler mod dyskinesi
- Pramipexol
Andre undersøgelses-id-numre
- 248.644
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Tourettes syndrom
-
University of Colorado, DenverRekrutteringKlinefelters syndrom | Trisomi X | XYY syndrom | XXXY og XXXXY syndrom | Xxyy syndrom | Xyyy syndrom | Xxxx syndrom | Xxxxx syndrom | Xxxyy syndrom | Xxyyy syndrom | Xyyyy syndrom | Mand med sexkromosommosaicismeForenede Stater
-
Riphah International UniversityAfsluttet
-
Riphah International UniversityAfsluttet
-
Shaare Zedek Medical CenterUkendtPræmenstruelt syndrom - PMS
-
Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.AfsluttetTidligere behandlet myelodysplastisk syndrom | Myelodysplastisk syndrom | Terapi-relateret myelodysplastisk syndrom | Sekundært myelodysplastisk syndrom | Refraktært højrisiko myelodysplastisk syndromForenede Stater
-
Esra ÖZERKTO Karatay UniversityRekrutteringEffekten af aromaterapiapplikation med bergamot og grapefrugt æteriske olier på PMS (Aromatherapy)Præmenstruelt syndrom - PMSKalkun
-
Hrain Biotechnology Co., Ltd.Shanghai Changzheng HospitalAktiv, ikke rekrutterendePOMES syndrom | Tilbagefaldende og refraktær POMES-syndromKina
-
Riphah International UniversityRekrutteringNedre kors syndromPakistan
-
Foundation University IslamabadRekruttering
-
University of CalgaryUkendtNefrotisk syndrom hos børn | Nefrotisk syndrom, minimal ændring | Nefrotisk syndrom, idiopatiskCanada
Kliniske forsøg med Placebo
-
SamA Pharmaceutical Co., LtdUkendtAkut bronkitis | Akut øvre luftvejsinfektionKorea, Republikken
-
National Institute on Drug Abuse (NIDA)AfsluttetBrug af cannabisForenede Stater
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyAfsluttetMandlige forsøgspersoner med type II-diabetes (T2DM)Tyskland
-
Heptares Therapeutics LimitedAfsluttetFarmakokinetik | SikkerhedsproblemerDet Forenede Kongerige
-
Regado Biosciences, Inc.AfsluttetSund frivilligForenede Stater
-
Texas A&M UniversityNutraboltAfsluttetGlucose and Insulin Response
-
Longeveron Inc.AfsluttetHypoplastisk venstre hjerte syndromForenede Stater
-
ItalfarmacoAfsluttetBeckers muskeldystrofiHolland, Italien
-
Universidade Estadual de LondrinaConselho Nacional de Desenvolvimento Científico e Tecnológico; Coordination...AfsluttetSund og rask | Kropssammensætning