Central Nervous System IndicationPhase 2NCT03749252

Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

A Phase 2 study testing P03277 in people with Central Nervous System Indication and Pediatric Patients, run by Guerbet at 16 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS… Read more about this study

Who is it for?: Ages 2 to 17 years
Conditions the study is for: Central Nervous System Indication, Pediatric Patients, Body Indication
What is being tested?: P03277
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 16 sitesin 5 countries
Study dates: 6 Nov 2018to 10 Aug 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

To be included in the study, the patient had to meet all the following criteria:
Female or male pediatric patient aged 2 to 17 years,
Patient with known or suspected lesion(s) scheduled to undergo routine contrast-enhanced MRI of CNS or of other organs including at least one organ among head and neck, thorax, abdomen, pelvis or musculoskeletal system (including extremities),
Patient whose parent(s) or legal guardian having read the information, provided their consent to patient's participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted,
Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial (as required by national regulations),
Patient affiliated to national health insurance according to local regulatory requirements.

Show all 30Show fewer

Non-inclusion Criteria:
Patients could not be included in the study if they presented with one or more of the following non-inclusion criteria:
Patient planned for treatment or procedure (e.g., surgery) that would prevent obtaining the required blood samples or performing other trial procedures between the screening visit and up to 1 day after gadopiclenol administration,
Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol PK parameters,
Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal ranges (eGFR calculated with bedside Schwartz equation),
Patients referred for MR Angiography,
Patient with history of bleeding disorder,
Patient with known severe liver disease,
Patient with known cardiac disease (e.g., heart rhythm anomalies, long QT syndrome),
Patient with any clinically significant abnormal 12-lead ECG that in the Investigator's opinion would affect the safety evaluation or place the patient at risk,
Patient with electrolyte or fluid imbalance that at Investigator's judgment presents undue risk assessed within 1 month prior to gadopiclenol administration,
Patient undergoing a change in chemotherapy within 1 day prior to or 1 day after gadopiclenol administration,
Patient who received any other contrast agent for CT and/or MRI within 1 week prior to or 1 week after gadopiclenol administration,
Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker),
Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs,
Patient with history of hypersensitivity caused by any contrast media / agents (iodinated or gadolinium-based),
Patient with known contraindication(s) to the use of any GBCA,
Pregnant or breast-feeding female patient (female patient with childbearing potential [who experienced menarche] must have a negative urine pregnancy test within 24 hours prior to gadopiclenol administration and must be using medically approved contraception* if sexually active),
Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient's safety or her/his ability to participate to the whole trial,
Patient unlikely to comply with the protocol, e.g., uncooperative attitude of parent(s) or legal guardian, inability to return for follow-up visits and unlikelihood of completing the trial,
Having participated in a clinical trial and having received any investigational product within 7 days prior to gadopiclenol administration or planned during the trial,
Patient previously included in this trial,
Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
medically approved contraception methods include: female sterilization, use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception, placement of an Intrauterine Device (IUD) or Intrauterine System (IUS), barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository).

Who cannot join

None listed.

Trial locations and contacts

16 sites in 5 countries.

Country

City, postcode or hospital

16 sites in 5 countries

Poland6 sites

Szpital Uniwersytecki nr 1 w Bydgoszczy im. dr Jurasza, Oddział Kliniczny Chirurgii Ogólnej i Onkologicznej Dzieci i Młodzieży
Bydgoszcz
Instytut Centrum Zdrowia Matki Polki
Lodz
Uniwersytecki Szpital Dziecięcy w Lublinie
Lublin
Klinika Chirurgii Dziecięcej
Rzeszów
Instytut "Pomnik -Centrum Zdrowia Dziecka"
Warsaw
Zakład Radiologii PediatrycznejSamodzielny Publ. Dziecięcy Szp. Kliniczny w Warszawie
Warsaw

Other trials in Poland

Bulgaria3 sites

MHAT Central Onco Hospital Ltd
Plovdiv
Acibadem City Clinic Tokuda Hospital
Sofia
MHAT Dr. Stoyan Kirkovich
Stara Zagora

Other trials in Bulgaria

Hungary3 sites

Semmelweis Egyetem II. sz Gyermekgyogyaszati Klinika
Budapest
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger
B.-A.-Z. Megyei Korhaz Gyermek-Egeszsegugyi Kozpont
Miskolc

Other trials in Hungary

Slovakia3 sites

II. Detská klinika SZU, Detská fakultná nemocnica s poliklinikou Banská Bystrica
Banská Bystrica
Klinika detí a dorastu JLF UK a UNM, Univerzitná nemocnica Martin
Martin
Faculty hospital Nitra, Clinic of neonates, children and adolescents
Nitra

Other trials in Slovakia

Ukraine1 site

Children's City Clinical Hospital
Dnipro

Other trials in Ukraine

About this study

Official title: Pharmacokinetics, Safety and Efficacy of a New Gadolinium-based Contrast Agent, P03277, in Pediatric Patients From 2 to 17 Years of Age Undergoing Central Nervous System Contrast-enhanced MRI

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach.

The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).

Read the detailed description

A population PK approach and an age-down staggered approach will be used. Patients will be recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and finally Young Children (2-6 years of age).

Conditions: Central Nervous System Indication, Pediatric Patients, Body Indication
Being tested: P03277

What participants receive

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

P03277Drug
Also called gadopiclenol
A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.

Study groups in NCT03749252
Study group	Role	What they receive
CNS Cohort 2-6 years	Experimental	Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI Receives: Drug: P03277
CNS Cohort 7-11 years	Experimental	Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI Receives: Drug: P03277
CNS Cohort 12-17 years	Experimental	Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI Receives: Drug: P03277
Body Cohort 2-6 years	Experimental	Pediatric patients aged 2-6 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) Receives: Drug: P03277
Body Cohort 7-11 years	Experimental	Pediatric patients aged 7-11 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) Receives: Drug: P03277
Body Cohort 12-17 years	Experimental	Pediatric patients aged 12-17 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system) Receives: Drug: P03277

What is being measured

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

Elimination Half-life
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Total Clearance
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Central Volume of Distribution
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Peripheral Volume of Distribution
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Area Under the Curve
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
Simulated Concentrations 10 Minutes Post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 10 minutes post-injection
Simulated Concentrations 20 Minutes Post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 20 minutes post-injection
Simulated Concentrations 30 Minutes Post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model.
This outcome was assessed only for the CNS cohort.
Measured: 30 minutes post-injection

Timeline

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

6 Nov 201810 Aug 2020

First posted21 Nov 2018
Study start6 Nov 2018
Primary completion18 Dec 2019
Study completion10 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Central Nervous System IndicationStudies 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 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03749252
Sponsor's protocol ID: GDX-44-007
Other IDs: 2018-001516-30, 2018
Status last verified: May 2022
First submitted: 20 Nov 2018
Last updated: 1 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Jurkiewicz E, Tsvetkova S, Grinberg A, Pasquiers B. Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. Invest Radiol. 2022 Aug 1;57(8):510-516. doi: 10.1097/RLI.0000000000000865. Epub 2022 Mar 2.
PubMed 35318970

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?

See locations

Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Not yet recruitingObservational study
Pediatric Von Hippel-Lindau Disease: Natural History, Predictive Factors, and Long-Term Functional Outcomes of Central Nervous System Hemangioblastomas
Von Hippel-Lindau Disease, Central Nervous System Hemangioblastoma
Recruiting
Stroke Alarm Efficacy Trial
Stroke Acute, Atrial Fibrillation
Recruiting
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
Chronic Subdural Hematomas, Cerebral Compression Due to Injury

All Central Nervous System Indication trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Efficacy of a New Gadolinium-based Contrast Agent, P03277, in Pediatric Patients From 2 to 17 Years of Age Undergoing Central Nervous System Contrast-enhanced MRI
ClinicalTrials.gov ID: NCT03749252
Acronym / sponsor ID: GDX-44-007
Conditions: Central Nervous System Indication, Pediatric Patients, Body Indication
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: 6 Nov 2018 (actual)
Primary completion: 18 Dec 2019 (actual)
Study completion: 10 Aug 2020 (actual)
First posted: 21 Nov 2018 (actual)
Results: Posted 1 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
CNS Cohort 2-6 years	Experimental	Drug: P03277Pediatric patients aged 2-6 years undergoing CNS contrast-enhanced MRI
CNS Cohort 7-11 years	Experimental	Drug: P03277Pediatric patients aged 7-11 years undergoing CNS contrast-enhanced MRI
CNS Cohort 12-17 years	Experimental	Drug: P03277Pediatric patients aged 12-17 years undergoing CNS contrast-enhanced MRI
Body Cohort 2-6 years	Experimental	Drug: P03277Pediatric patients aged 2-6 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)
Body Cohort 7-11 years	Experimental	Drug: P03277Pediatric patients aged 7-11 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)
Body Cohort 12-17 years	Experimental	Drug: P03277Pediatric patients aged 12-17 years undergoing contrast-enhanced MRI of other body organs (head and neck, thorax, abdomen, pelvis or musculoskeletal system)

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (30 listed)

Female or male pediatric patient aged 2 to 17 years,
Patient with known or suspected lesion(s) scheduled to undergo routine contrast-enhanced MRI of CNS or of other organs including at least one organ among head and neck, thorax, abdomen, pelvis or musculoskeletal system (including extremities),
Patient whose parent(s) or legal guardian having read the information, provided their consent to patient's participation in writing by dating and signing the informed consent prior to any trial related procedure being conducted,
Patient with capacity of understanding who received age- and maturity-appropriate information and provided his/her assent to participate in the trial (as required by national regulations),
Patient affiliated to national health insurance according to local regulatory requirements.

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
P03277Also: gadopiclenolA dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.	Drug	Body Cohort 12-17 years, Body Cohort 2-6 years, Body Cohort 7-11 years, CNS Cohort 12-17 years, CNS Cohort 2-6 years, CNS Cohort 7-11 years

Primary outcome

Elimination Half-life
Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Total Clearance
Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Central Volume of Distribution
Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Peripheral Volume of Distribution
Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Area Under the Curve
Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 10 Minutes Post-injection
Time frame: 10 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 20 Minutes Post-injection
Time frame: 20 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.
Simulated Concentrations 30 Minutes Post-injection
Time frame: 30 minutes post-injection
P03277 pharmacokinetic parameters in plasma were determined from the population PK model. This outcome was assessed only for the CNS cohort.

Results and safety

Results posted to the registry on 1 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CNS & Body Cohorts 2-6 Years	26	26
CNS & Body Cohorts 7-11 Years	23	23
CNS & Body Cohorts 12-17 Years	31	31

Primary outcome: Elimination Half-life

Time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours. Median (Full Range). Unit: hours

Measure	CNS Cohort 2-6 Years n = 20	CNS Cohort 7-11 Years n = 20	CNS Cohort 12-17 Years n = 19
Value	1.29 (0.69 to 3.38)	1.48 (0.83 to 3.20)	1.77 (1.00 to 3.57)

Population analysed: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period

Primary outcome: Total Clearance

Measure	CNS Cohort 2-6 Years n = 20	CNS Cohort 7-11 Years n = 20	CNS Cohort 12-17 Years n = 19
Value	0.12 (0.05 to 0.28)	0.10 (0.04 to 0.24)	0.08 (0.04 to 0.20)

Population analysed: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period

Primary outcome: Central Volume of Distribution

Measure	CNS Cohort 2-6 Years n = 20	CNS Cohort 7-11 Years n = 20	CNS Cohort 12-17 Years n = 19
Value	0.12 (0.06 to 0.26)	0.12 (0.06 to 0.24)	0.11 (0.05 to 0.24)

Population analysed: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period

Primary outcome: Peripheral Volume of Distribution

Measure	CNS Cohort 2-6 Years n = 20	CNS Cohort 7-11 Years n = 20	CNS Cohort 12-17 Years n = 19
Value	0.06 (0.06 to 0.06)	0.06 (0.06 to 0.06)	0.06 (0.06 to 0.06)

Population analysed: All patients of the CNS cohort who received gadopiclenol administration except one patient, whose PK blood samples were assessed out of stability period

Adverse events

Time frame: Adverse events were recorded from informed consent signature untill the end of the study (up to 120 days after gadopiclenol administration).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CNS & Body Cohorts 2-6 Years	1 of 26 (3.8%)	4 of 26 (15.4%)	0 of 26
CNS & Body Cohorts 7-11 Years	0 of 23 (0%)	6 of 23 (26.1%)	0 of 23
CNS & Body Cohorts 12-17 Years	2 of 31 (6.5%)	4 of 31 (12.9%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35318970Jurkiewicz E, Tsvetkova S, Grinberg A, Pasquiers B. Pharmacokinetics, Safety, and Efficacy of Gadopiclenol in Pediatric Patients Aged 2 to 17 Years. Invest Radiol. 2022 Aug 1;57(8):510-516. doi: 10.1097/RLI.0000000000000865. Epub 2022 Mar 2.
Individual participant dataSharing planned: No

Related trials for Central Nervous System Indication

Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Not yet recruitingObservational study
Pediatric Von Hippel-Lindau Disease: Natural History, Predictive Factors, and Long-Term Functional Outcomes of Central Nervous System Hemangioblastomas
Von Hippel-Lindau Disease, Central Nervous System Hemangioblastoma
Recruiting
Stroke Alarm Efficacy Trial
Stroke Acute, Atrial Fibrillation
Recruiting
Middle Meningeal Artery Embolization for Chronic Subdural Hematomas (STORMM)
Chronic Subdural Hematomas, Cerebral Compression Due to Injury

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.

Elżbieta Jurkiewicz, MD principal investigator

Instytut Pomnik

16 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing P03277 in people with Central Nervous System Indication and Pediatric Patients, run by Guerbet at 16 sites in 5 countries.

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 30 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Poland, Bulgaria, Hungary, Slovakia, Ukraine. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Elimination Half-life (time frame: 4 blood samples per patient were taken post-injection for PK analysis, one within each window: 1 min to 20 min, 30 min to 45 min, 2 to 3 hours and 7 to 8 hours). The study lists 8 primary outcomes in all. 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 NCT03749252, 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 1 Jun 2022.