Tourette SyndromeNCT04076852
Gilles de la Tourette Syndrome (TS) and Seasonality
An observational study of Tourette Syndrome, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette. Read more about this study
- Who is it for?
- Ages 6 to 50 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Administration of questionnaires
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 6 Apr 2018to 31 May 2019
- Phase
- Observational
- 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 6 to 50 years
- All sexes
- Child, Adult
Study population: Being a pilot study it was not possible to develop a sample study, but the sample number is designed based on the tourette center turnout
Who may be able to join
- Patients attending the Tourette Center since January 2012.
- Males and females.
- Age between 6 and 50 (completed).
- Diagnosis of Tourette syndrome ascertained
- Presence of a value equal to or greater than 15/40 of the Y-BOCS.
Who cannot join
- Presence of allergic pathology.
- Presence of significant psychiatric symptoms, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gilles de la Tourette Syndrome (TS) and Seasonality: a Pilot Study
This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette.
- Conditions
- Tourette Syndrome
- Being tested
- Administration of questionnaires
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of questionnairesOther
According to clinical practice, the following questionnaires are administered:
- Y-GTSS
- Y-BOCS or cY-BOCS
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Y-GTSS score at 6 months.
The primary objective is to investigate the correlation between seasons and different phenotypic variation through the administration of a specific questionnaire (Y-GTSS) and questions about the subjective perception of the ticcogenic variation.
Measured: 4, 8, 12 months.
Secondary outcomes (1)
Change from baseline Y-BOCS score at 6 months.
Secondary objective is to investigate the correlation between seasons and variation of severity of obsessive-compulsive disorder (OCD) through the administration of Y-BOCS, a questionnaire indicated to evaluate the severity of obsessive-compulsive disorder.
Measured: 4, 8, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start6 Apr 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Satisfactory results, in terms of both clinical and statistical, were achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Porta, Principal investigator, IRCCS Orthopedic Institute Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076852
- Sponsor's protocol ID
- Stagionalità TS (PI: M Porta)
- Other IDs
- L3036
- Status last verified
- Aug 2019
- First submitted
- 29 Dec 2018
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gilles de la Tourette Syndrome (TS) and Seasonality: a Pilot Study
- ClinicalTrials.gov ID
- NCT04076852
- Acronym / sponsor ID
- Stagionalità TS (PI: M Porta)
- Conditions
- Tourette Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Satisfactory results, in terms of both clinical and statistical, were achieved.
- Enrolment
- 39 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 3 Sep 2019 (actual)
- 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.
This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 6 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Being a pilot study it was not possible to develop a sample study, but the sample number is designed based on the tourette center turnout
Key inclusion criteria (5 listed)
- Patients attending the Tourette Center since January 2012.
- Males and females.
- Age between 6 and 50 (completed).
- Diagnosis of Tourette syndrome ascertained
- Presence of a value equal to or greater than 15/40 of the Y-BOCS.
Key exclusion criteria (2 listed)
- Presence of allergic pathology.
- Presence of significant psychiatric symptoms, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD)
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 |
|---|---|---|
| Administration of questionnairesAccording to clinical practice, the following questionnaires are administered: * Y-GTSS * Y-BOCS or cY-BOCS | Other | – |
Primary outcome
Change from baseline Y-GTSS score at 6 months.
Time frame: 4, 8, 12 months.
The primary objective is to investigate the correlation between seasons and different phenotypic variation through the administration of a specific questionnaire (Y-GTSS) and questions about the subjective perception of the ticcogenic variation.
1 secondary outcome
Change from baseline Y-BOCS score at 6 months.
Time frame: 4, 8, 12 months.
Results and safety
The study was stopped early (reason given: Satisfactory results, in terms of both clinical and statistical, were achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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.
Mauro Porta principal investigator
IRCCS Orthopedic Institute Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Satisfactory results, in terms of both clinical and statistical, were achieved.). Results are not available in the source record.
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?
Change from baseline Y-GTSS score at 6 months. (time frame: 4, 8, 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2023.