Cervical PainTIPIC-UNVNCT03804112
TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up
An observational study of Cervical Pain and Vasculitis, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
Trial summary
TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Pain, Vasculitis
- What is being tested?
- Ultrasound exam with Doppler and Blood samples
- How many people
- 47 participants
- Where
- 6 sitesFrance
- Study dates
- 17 Dec 2018to 18 Feb 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patient previously identified with a TIPC syndrom
Who may be able to join
- Patients with at least one episode of TIPIC syndrome for more than 12 months
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Montpellier
Montpellier, 34295
Hôpital Pitié Salpêtrière
Paris, 75013
Centre Hospitalier de Saint-Anne
Paris, 75014
Fondation Ophtalmologique A. de Rothschild
Paris, 75019
CHU de Toulouse
Toulouse, 31059
CHU de TOURS
Tours, 37044
About this study
TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound
- Conditions
- Cervical Pain, Vasculitis
- Being tested
- Ultrasound exam with Doppler, Blood samples
- Medical subject headings
- Neck Pain, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound exam with DopplerDiagnostic test
Ultrasound exam of the neck to search a perivascular inflammation at the level of the carotid bifurcation.
Blood samplesBiological
blood count , CRP and viral serologies (herpes virus, chlamydia, mycoplasma),
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the incidence of recurrence of TIPIC syndrome after a first episode
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start17 Dec 2018
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
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 Cervical PainStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804112
- Sponsor's protocol ID
- MOA_2018_2
- Acronym
- TIPIC-UNV
- Status last verified
- Jun 2021
- First submitted
- 11 Jan 2019
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Obadia M, Nasr N, Volle G, Charbonneau F, Guillaume J, Naggara O, Sadik JC, Lecler A. Long-term clinical and ultrasound follow-up after transient perivascular inflammation of the carotid artery (TIPIC) syndrome: a multicenter study. Cephalalgia. 2024 Feb;44(2):3331024241230247. doi: 10.1177/03331024241230247.
PubMed 38318645
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransIent Perivascular Inflammation of the Carotid Artery (TIPIC) Syndrome: Clinical and Radiological Follow-up
- ClinicalTrials.gov ID
- NCT03804112
- Acronym / sponsor ID
- TIPIC-UNV / MOA_2018_2
- Conditions
- Cervical Pain, Vasculitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 15 Jan 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.
TIPIC syndrome (previously called carotidynia) is a rare entity of unknown cause, where the patient has a temporary cervical pain associated with a suggestive inflammation around the carotid artery. Usually considered as a unique and benign episode, some patients have recurrences and the follow-up is usually short. In this study the investigators aim to evaluate patients who presented a TIPIC episode at least 3 months before, clinically and with a cervical doppler ultrasound
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patient previously identified with a TIPC syndrom
Key inclusion criteria (1 listed)
- Patients with at least one episode of TIPIC syndrome for more than 12 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound exam with DopplerUltrasound exam of the neck to search a perivascular inflammation at the level of the carotid bifurcation. | Diagnostic test | – |
| Blood samplesblood count , CRP and viral serologies (herpes virus, chlamydia, mycoplasma), | Biological | – |
Primary outcome
Assess the incidence of recurrence of TIPIC syndrome after a first episode
Time frame: 1 year
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 22 Jun 2021.
- Derived from this study: PubMed 38318645Obadia M, Nasr N, Volle G, Charbonneau F, Guillaume J, Naggara O, Sadik JC, Lecler A. Long-term clinical and ultrasound follow-up after transient perivascular inflammation of the carotid artery (TIPIC) syndrome: a multicenter study. Cephalalgia. 2024 Feb;44(2):3331024241230247. doi: 10.1177/03331024241230247.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Pain and Vasculitis, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
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 1 inclusion and 0 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 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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 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?
Assess the incidence of recurrence of TIPIC syndrome after a first episode (time frame: 1 year). 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 NCT03804112, 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 22 Jun 2021.