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

keskiviikko 7. toukokuuta 2014 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

63

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

6 vuotta - 17 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Nelinkertaistaa

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Plasebo
Lääke: Plasebo
Muut: Pramipexole
Lääke: pramipexole immediate release (IR)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: baseline and Week 6
baseline and Week 6

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Boehringer Ingelheim

Julkaisuja ja hyödyllisiä linkkejä

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Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Tiistai 1. tammikuuta 2008

Ensisijainen valmistuminen (Todellinen)

Maanantai 1. kesäkuuta 2009

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 14. marraskuuta 2007

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 14. marraskuuta 2007

Ensimmäinen Lähetetty (Arvio)

Torstai 15. marraskuuta 2007

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Perjantai 16. toukokuuta 2014

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 7. toukokuuta 2014

Viimeksi vahvistettu

Lauantai 1. maaliskuuta 2014

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 248.644

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