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Completed

NCT Number: NCT00558467

Pramipexole Pilot Phase II Study in Children and Adolescents 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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

248.644.49001 Boehringer Ingelheim Investigational Site, Hanover, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

pramipexole immediate release (IR)

Drug

Placebo

Drug

Primary outcomes

  1. Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale

    Time frame: 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.

Secondary outcomes

  1. Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 1

    Time frame: 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

  2. Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 2

    Time frame: 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

  3. Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 3

    Time frame: 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

  4. Mean Change From Baseline in Total Tic Score of the Yale Global Tic Severity Scale at Week 4

    Time frame: 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

  5. Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 6

    Time frame: 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)

  6. Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 1

    Time frame: 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)

  7. Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 2

    Time frame: 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)

  8. Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 3

    Time frame: 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)

  9. Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale Due to Motor and Phonic Tics at Week 4

    Time frame: 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)

  10. Clinical Global Impressions - Improvement at 1 Week

    Time frame: 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.

  11. Clinical Global Impressions - Improvement at Week 2

    Time frame: 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.

  12. Clinical Global Impressions - Improvement at Week 3

    Time frame: 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.

  13. Clinical Global Impressions - Improvement at Week 4

    Time frame: 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.

  14. Clinical Global Impressions - Improvement at Week 6

    Time frame: 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.

  15. Clinical Global Impressions - Severity of Illness at Week 1

    Time frame: 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.

  16. Clinical Global Impressions - Severity of Illness at Week 2

    Time frame: 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.

  17. Clinical Global Impressions - Severity of Illness at Week 3

    Time frame: 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.

  18. Clinical Global Impressions - Severity of Illness at Week 4

    Time frame: 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.

  19. Clinical Global Impressions - Severity of Illness at Week 6

    Time frame: 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.

  20. Patient Global Impression at Week 1

    Time frame: 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).

  21. Patient Global Impression at Week 2

    Time frame: 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).

  22. Patient Global Impression at Week 3

    Time frame: 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).

  23. Patient Global Impression at Week 4

    Time frame: 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).

  24. Patient Global Impression at Week 6

    Time frame: 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).

  25. Clinically Significant Abnormalities in Vital Signs (Orthostatic Reaction and Pulse Rate), and Serum Chemistry.

    Time frame: baseline and Week 6

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2009
First posted
Nov 15, 2007
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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