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Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria

7 maggio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

63

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Germania
      • Hannover, Germania
        • 248.644.49001 Boehringer Ingelheim Investigational Site
      • Ulm, Germania
        • 248.644.49004 Boehringer Ingelheim Investigational Site
  • Stati Uniti
    • Florida
      • Bradenton, Florida, Stati Uniti
        • 248.644.0026 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, Stati Uniti
        • 248.644.0025 Boehringer Ingelheim Investigational Site
    • Georgia
      • Columbus, Georgia, Stati Uniti
        • 248.644.0006 Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, Stati Uniti
        • 248.644.0012 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Cambridge, Massachusetts, Stati Uniti
        • 248.644.0005 Boehringer Ingelheim Investigational Site
    • New York
      • Manhasset, New York, Stati Uniti
        • 248.644.0003 Boehringer Ingelheim Investigational Site
      • New York, New York, Stati Uniti
        • 248.644.0009 Boehringer Ingelheim Investigational Site
      • New York, New York, Stati Uniti
        • 248.644.0018 Boehringer Ingelheim Investigational Site
      • Orangeburg, New York, Stati Uniti
        • 248.644.0013 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti
        • 248.644.0029 Boehringer Ingelheim Investigational Site
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
        • 248.644.0010 Boehringer Ingelheim Investigational Site
    • Tennessee
      • Memphis, Tennessee, Stati Uniti
        • 248.644.0030 Boehringer Ingelheim Investigational Site
    • Texas
      • Houston, Texas, Stati Uniti
        • 248.644.0008 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, Stati Uniti
        • 248.644.0023 Boehringer Ingelheim Investigational Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Altro: Pramipexole
Droga: pramipexole immediate release (IR)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: baseline and Week 6
baseline and Week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Boehringer Ingelheim

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2008

Completamento primario (Effettivo)

1 giugno 2009

Date di iscrizione allo studio

Primo inviato

14 novembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

14 novembre 2007

Primo Inserito (Stima)

15 novembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2014

Ultimo verificato

1 marzo 2014

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 248.644

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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