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

7. Mai 2014 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

63

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Sonstiges: Pramipexole
Arzneimittel: pramipexole immediate release (IR)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: baseline and Week 6
baseline and Week 6

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2008

Primärer Abschluss (Tatsächlich)

1. Juni 2009

Studienanmeldedaten

Zuerst eingereicht

14. November 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. November 2007

Zuerst gepostet (Schätzen)

15. November 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

16. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2014

Zuletzt verifiziert

1. März 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 248.644

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