Tourette SyndromeNCT00004433
Randomized Study of Pergolide in Children With Tourette Syndrome
A study testing pergolide in people with Tourette Syndrome, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
OBJECTIVES: I. Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome (GTS). II. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- pergolide
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Dec 1994to Sep 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
DSM IV primary diagnosis of Tourette syndrome (GTS) Multiple Axis I and Axis II diagnoses allowed
Tourette symptom severity great enough to warrant medication (CGI severity index at least 4)
No chronic motor tic disorder or transient tic disorder, anorexia nervosa, pervasive developmental disorders, substance/alcohol abuse or dependence within the past year, schizophrenia or any psychotic disorder
--Prior/Concurrent Therapy--
At least 4 weeks since prior neuroleptic therapy
At least 2 weeks since all other prior medications
No concurrent neuroleptic therapy or psychotropic therapy (i.e., antidepressant or anticholinergic)
No concurrent medication that may alter or interact with pergolide
--Patient Characteristics--
Performance status: Outpatient status
Hematopoietic: Normal or clinically insignificant values
Hepatic: Normal or clinically insignificant values
Renal: Normal or clinically insignificant values
Cardiovascular: Normal electrocardiogram
Other: No serious or unstable medical illness (i.e., diabetes, seizure disorder); Must be able to perform required measurements (i.e., no low I.Q.); Effective contraception required by all fertile patients
About this study
OBJECTIVES:
- Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome (GTS).
II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics.
III. Determine efficacy of pergolide for tic control in these patients.
Read the detailed description
PROTOCOL OUTLINE:
This is a three part study: part I is a randomized, double blind, fixed single dose study; part II is a randomized, open label, stratified study; and part III is a randomized, double blind, placebo controlled study.
Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. Part II patients are randomized to receive either low or high dose pergolide for 4 weeks.
Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. Total treatment duration is 16 weeks.
Patients are followed at 6 months.
Completion date provided represents the completion date of the grant per OOPD records
- Conditions
- Tourette Syndrome
- Being tested
- pergolide
- Keywords
- Tourette syndrome, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Tourette Syndrome, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pergolideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startDec 1994
- Study completionSep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 74 participants
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Floyd R. Sallee, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004433
- Sponsor's protocol ID
- 199/13395
- Other IDs
- MUSC-6130, MUSC-FDR001111
- Status last verified
- Mar 2000
- First submitted
- 18 Oct 1999
- Last updated
- 25 Mar 2015
- Results posted
- No
Publications
Griesemer DA. Pergolide in the management of Tourette syndrome. J Child Neurol. 1997 Sep;12(6):402-3. No abstract available.
PubMed 9309526Lipinski JF, Sallee FR, Jackson C, Sethuraman G. Dopamine agonist treatment of Tourette disorder in children: results of an open-label trial of pergolide. Mov Disord. 1997 May;12(3):402-7. doi: 10.1002/mds.870120320.
PubMed 9159736
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Pergolide in Children With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT00004433
- Acronym / sponsor ID
- 199/13395
- Conditions
- Tourette Syndrome
- Keywords
- Tourette syndrome, neurologic and psychiatric disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Dec 1994
- Study completion
- Sep 2002
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- Evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at D2 sites in children 7 to 17 with tourette syndrome (GTS).
II. Compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics.
III. Determine efficacy of pergolide for tic control in these patients.
Detailed description
PROTOCOL OUTLINE:
This is a three part study: part I is a randomized, double blind, fixed single dose study; part II is a randomized, open label, stratified study; and part III is a randomized, double blind, placebo controlled study.
Part I patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. Part II patients are randomized to receive either low or high dose pergolide for 4 weeks.
Part III patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. Patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. Total treatment duration is 16 weeks.
Patients are followed at 6 months.
Completion date provided represents the completion date of the grant per OOPD records
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pergolide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Background: PubMed 9309526Griesemer DA. Pergolide in the management of Tourette syndrome. J Child Neurol. 1997 Sep;12(6):402-3. No abstract available.
- Background: PubMed 9159736Lipinski JF, Sallee FR, Jackson C, Sethuraman G. Dopamine agonist treatment of Tourette disorder in children: results of an open-label trial of pergolide. Mov Disord. 1997 May;12(3):402-7. doi: 10.1002/mds.870120320.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Floyd R. Sallee study chair
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing pergolide in people with Tourette Syndrome, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.