Tic DisorderPhase 35LGrNCT01501695

Phase III Study of 5LGr to Treat Tic Disorder

A Phase 3 study testing 5LGr and tiapride in people with Tic Disorder and Tourette Syndrome, run by Tasly Pharmaceuticals, Inc..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders. Read more about this study

Who is it for?: Ages 5 to 18 years
Conditions the study is for: Tic Disorder, Tourette Syndrome, Chronic Tic Disorder
What is being tested?: 5LGr and tiapride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 603 participants
Where: No sites listed yet
Study dates: Jan 2008to Oct 2011
Phase: Phase 3
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 5 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

>1 year history of diagnosed tic disorder;
age:5-18 yrs;
YGTSS score>=30 at baseline.

Who cannot join

Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.
Any indefinite tic disorder or tic disorders caused by medication.
Participation to other studies.
Patients with loose stool.

About this study

Official title: A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder

The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.

Read the detailed description

5LGr is a kind of traditional Chinese medicine(TCM) which under the direction of TCM theory.The aim of this study is prove the effective and safety of 5LGr in children and adolescence of Tic syndrome sub-population with specific TCM syndrome differentiation, when compared with tiapride and placebo.

Conditions: Tic Disorder, Tourette Syndrome, Chronic Tic Disorder
Being tested: 5LGr, tiapride, placebo
Keywords: tic disorder, pediatric
Medical subject headings: Tic Disorders, Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5LGrDrug
Also called Wuling Granule
Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.
tiaprideDrug
Also called Tiapridel, Tiapridax
dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.
Total duration:8 weeks.
placeboDrug
Also called Blank tablet
mimetic granule: same with 5LGr mimetic tablet: same with tiapride

Study groups in NCT01501695
Study group	Role	What they receive
5LGr, granule and placebo tablet	Experimental	Drug:5LGr; Dosage form:Granule;Strength:5 gram/sack;Mimic Tablet:0 mg/tablet. Dosage: 5LGr Granule: 1 sack, t.i.d. for patients less than 12 yrs,whereas 1.5 sacks, t.i.d. for patients 13-18 yrs. Mimic tablet:For patients 5-12 yrs: 0.5 tablet, b.i.d for first 2 weeks, then 1 tablet, bid for next 6 weeks; for patients 13-18 yrs: tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks. Receives: Drug: 5LGr
tiapride tabletand mimic 5LGr granule	Active comparator	Tiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo. Dosage: Tiaptride tablet: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks. Mimic 5LGr Granule:Strength:0 gram/sack.Dosage:1 sack for patients less than 12 yrs,while 1.5 sacks for patients 13-18 yrs.Frequency: T.i.d. Duration: 8 weeks. Receives: Drug: tiapride
placebo, granule and tablet	Placebo comparator	This arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients. Dosage form: Mimic Granule:Strength:0 gram/sack Dosage:1 sack, t.i.d for patients less than 12 yrs,while 1.5 sacks, t.i.d for patients 13-18 yrs. Mimic tablet:Strength:0 mg/tablet.For patients 5-12 yrs: 0.5 tablets b.i.d for first 2 weeks, then 1 tablet,b.i.d for next 6 weeks; for patients 13-18 yrs:1 tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks. Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
The outcome will be assessed at 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks.
Measured: Within 8 weeks of completion intervention.

Secondary outcomes (3)

Change of syndrome scales from baseline at 8 weeks;
Measured: Within 8 weeks of completion intervention.
Change of YGTSS scores from baseline at 2 weeks;
Measured: within 2 weeks of intervention
Change of syndrome scales from baseline at 2 weeks;
Measured: Within 2 weeks of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Oct 2011

First posted29 Dec 2011 (estimated)
Study startJan 2008
Primary completionNov 2010
Study completionOct 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tic DisorderStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 603 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01501695
Sponsor's protocol ID: NCT00797953
Acronym: 5LGr
Status last verified: Dec 2012
First submitted: 26 Dec 2011
Last updated: 12 Dec 2012
Results posted: No
Data monitoring committee: Yes

Publications

Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.
PubMed 26072932

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease

All Tic Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 3-arm Phase III Study of 5LGr, Tiapride or Placebo in Pediatric Patients With Tic Disorder
ClinicalTrials.gov ID: NCT01501695
Acronym / sponsor ID: 5LGr / NCT00797953
Conditions: Tic Disorder, Tourette Syndrome, Chronic Tic Disorder
Keywords: tic disorder, pediatric
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 603 participants (actual)
Lead sponsor: Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Nov 2010 (actual)
Study completion: Oct 2011 (actual)
First posted: 29 Dec 2011 (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.

The purpose of this study is to evaluate the effective and safety of 5LGr in pediatric patients with tic disorders.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
5LGr, granule and placebo tablet	Experimental	Drug: 5LGrDrug:5LGr; Dosage form:Granule;Strength:5 gram/sack;Mimic Tablet:0 mg/tablet. Dosage: 5LGr Granule: 1 sack, t.i.d. for patients less than 12 yrs,whereas 1.5 sacks, t.i.d. for patients 13-18 yrs. Mimic tablet:For patients 5-12 yrs: 0.5 tablet, b.i.d for first 2 weeks, then 1 tablet, bid for next 6 weeks; for patients 13-18 yrs: tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks.
tiapride tabletand mimic 5LGr granule	Active comparator	Drug: tiaprideTiapride are 100 mg scored tablets. Mimic 5LGr granule are preparation that contain no active ingredient, and act as placebo. Dosage: Tiaptride tablet: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks. Mimic 5LGr Granule:Strength:0 gram/sack.Dosage:1 sack for patients less than 12 yrs,while 1.5 sacks for patients 13-18 yrs.Frequency: T.i.d. Duration: 8 weeks.
placebo, granule and tablet	Placebo comparator	Drug: placeboThis arm includes mimic preparation of 5LGr granule and tiapride tablets , which doesn't contain active ingredients. Dosage form: Mimic Granule:Strength:0 gram/sack Dosage:1 sack, t.i.d for patients less than 12 yrs,while 1.5 sacks, t.i.d for patients 13-18 yrs. Mimic tablet:Strength:0 mg/tablet.For patients 5-12 yrs: 0.5 tablets b.i.d for first 2 weeks, then 1 tablet,b.i.d for next 6 weeks; for patients 13-18 yrs:1 tablet b.i.d for first 2 weeks, then 2 tablets b.i.d for next 6 weeks. Duration: 8 weeks.

Who may qualify

Ages: 5 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

>1 year history of diagnosed tic disorder;
age:5-18 yrs;
YGTSS score>=30 at baseline.

Key exclusion criteria (4 listed)

Diagnosed with hyperactivity disorder,epilepsy,chorea,autism,obsessive-compulsive disorder,mental retardation,athetosis,Wilson's disease.
Any indefinite tic disorder or tic disorders caused by medication.
Participation to other studies.
Patients with loose stool.

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
5LGrAlso: Wuling GranuleDosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.	Drug	5LGr, granule and placebo tablet
tiaprideAlso: Tiapridel, Tiapridaxdosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks. Total duration:8 weeks.	Drug	tiapride tabletand mimic 5LGr granule
placeboAlso: Blank tabletmimetic granule: same with 5LGr mimetic tablet: same with tiapride	Drug	placebo, granule and tablet

Primary outcome

Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks
Time frame: Within 8 weeks of completion intervention.
The outcome will be assessed at 8th weeks. And patients who judged as effective by investigator will be included in a follow-up period up to 4 weeks.

3 secondary outcomes

Change of syndrome scales from baseline at 8 weeks;
Time frame: Within 8 weeks of completion intervention.
Change of YGTSS scores from baseline at 2 weeks;
Time frame: within 2 weeks of intervention
Change of syndrome scales from baseline at 2 weeks;
Time frame: Within 2 weeks of intervention

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 12 Dec 2012.
Derived from this study: PubMed 26072932Zheng Y, Zhang ZJ, Han XM, Ding Y, Chen YY, Wang XF, Wei XW, Wang MJ, Cheng Y, Nie ZH, Zhao M, Zheng XX. A proprietary herbal medicine (5-Ling Granule) for Tourette syndrome: a randomized controlled trial. J Child Psychol Psychiatry. 2016 Jan;57(1):74-83. doi: 10.1111/jcpp.12432. Epub 2015 Jun 13.
ManufacturerLink provided by the sponsor.

Related trials for Tic Disorder

RecruitingObservational study
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
Tics, Functional Tics
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation for Chronic Tic Disorders/Tourette's Syndrome in Children and Adolescents
Tourette Syndrome, Chronic Tic Disorder
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Recruiting
Deep Brain Stimulation Therapy in Movement Disorders
Parkinson's Disease

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.

Xinmin Han, M.D. principal investigator

Nanjing University of TCM affiliated hospital

Yi zheng principal investigator

Capital Medical University

Minjie Wang, M.D. principal investigator

Nanjing Medical college Attached Brain Branch Hospital

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 5LGr and tiapride in people with Tic Disorder and Tourette Syndrome, run by Tasly Pharmaceuticals, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. 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 12 Dec 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

What does the primary outcome measure?

Yale Global Tic Severity Scale(YGTSS) score change from baseline at 8 weeks (time frame: Within 8 weeks of completion intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01501695, which also lists 1 linked publication.

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 12 Dec 2012.