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

7. mai 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

63

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Legemiddel: Placebo
Annen: Pramipexole
Legemiddel: pramipexole immediate release (IR)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2008

Primær fullføring (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først innsendt

14. november 2007

Først innsendt som oppfylte QC-kriteriene

14. november 2007

Først lagt ut (Anslag)

15. november 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2014

Sist bekreftet

1. mars 2014

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Andre studie-ID-numre

  • 248.644

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