A study of intravenous amisulpride as prevention of post-operative nausea and vomiting in children

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Acacia Pharma Limited

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

8 Oct 2023 → 3 Jun 2025

Decision date (initial)

2025-01-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Acacia Pharma Ltd (a subsidiary of Eagle Pharmaceuticals, Inc)

External identifiers

EU CT number

2024-518778-15-00

EudraCT number

2022-002947-23

ClinicalTrials.gov

NCT05546359

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Prophylaxis, Pharmacokinetic, Safety

To evaluate the efficacy of IV amisulpride in the prevention of PONV (Prevention of post-operative nausea and vomiting) in pediatric patients.

Secondary objectives 3

1. To determine a suitable dose of IV amisulpride for PONV prophylaxis in pediatric patients.
2. To assess the safety and tolerability of IV amisulpride in pediatric patients.
3. To characterize the pharmacokinetics of IV amisulpride in pediatric patients

Conditions and MedDRA coding

post-operative nausea and vomiting in pediatric patients

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female patients aged from full-term birth (in France, from one month of age) to 17 years of age
2. Signed informed consent form and/or assent and willingness of patient and parents to participate in the trial
3. Patients undergoing non-emergency surgery, preferentially eye surgery, adenotonsillectomy or otoplasty, under general anesthesia (other than total intravenous anesthesia with propofol) expected to last at least 30 minutes from induction of anesthesia to removal of ETT or LMA
4. American Society of Anesthesiologists (ASA) risk score I-III
5. For females of child-bearing potential, defined as fertile, following menarche and until becoming post-menopausal (defined as no menses for 12 months without an alternative medical cause; a high follicle stimulating hormone level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy, but in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient) unless permanently sterilized by a reliable method such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy: ability and willingness to use a highly effective form of contraception (as defined in the guideline “Recommendations related to contraception and pregnancy testing in clinical trials”, version 1.1, issued by the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency) between the date of screening and at least 48 hours after administration of study drug: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o oral o intravaginal o transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation: o oral o injectable o implantable • intrauterine device • intrauterine hormone-releasing system • bilateral tubal occlusion • vasectomized partner (provided that partner is the sole sexual partner of the patient and that the vasectomized partner has received medical assessment of the surgical success) • sexual abstinence.

Exclusion criteria 17

1. Patients scheduled to undergo transplant or CNS surgery
2. Patients scheduled to receive only a local anesthetic and/or regional neuraxial (intrathecal or epidural) block (without general anesthesia) or to receive general anesthesia involving total intravenous anesthesia (TIVA) with propofol
3. Patients who, in the opinion of the Investigator, are expected to remain ventilated for a significant period after surgery
4. Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
5. Patients who are expected to receive systemic pre/peri-operative corticosteroid therapy other than as anti-emetic prophylaxis
6. Patients receiving amisulpride for any indication within the 2 weeks prior to randomization
7. Patients known to be allergic to amisulpride or any of the excipients of amisulpride drug product; or to dexamethasone or ondansetron
8. Patients with a significant ongoing history of vestibular disease or dizziness
9. Patients being treated with regular anti-emetic therapy (dosed at least three times per week), which is still ongoing less than 1 week prior to screening
10. Patients being treated with levodopa
11. Patients who are pregnant or breast feeding
12. Patients with congenital long QT syndrome, or with factors that predispose to QT prolongation, such as low left ventricular ejection fraction, left ventricular hypertrophy, ischemia, slow heart rate, or electrolyte abnormalities including hypokalemia and hypomagnesemia
13. Patients with a tumor of the anterior pituitary
14. Patients who have received emetogenic anti-cancer chemotherapy in the previous 4 weeks
15. Any other concurrent disease or illness that, in the opinion of the investigator makes the patient unsuitable for the study
16. Patients who have previously participated in this study or who have participated in another interventional clinical study involving pharmacological therapy within the previous 28 days (or longer exclusion period, if required by national or local regulations)
17. Where local laws/regulations require: patients under legal protection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Complete Response (absence of PONV), defined as no vomiting/retching and no use of anti-emetic rescue medication, during the first 24 hours after completion of surgery

Secondary endpoints 9

1. Efficacy: Occurrence of post-operative vomiting/retching
2. Efficacy: Use of rescue medication
3. Efficacy: Occurrence and severity of post-operative nausea
4. Efficacy: Time to emergence of PONV
5. Efficacy: Time to emergence of vomiting/retching, significant nausea, and rescue medication, individually
6. Efficacy: Different variables (complete response, vomiting/retching, use of rescue medication) during different time ranges after the end of surgery (0-2 h, 2-6 h and 6-24 h)
7. Efficacy: The above variables in the sub-groups of patients who did and did not receive opioid analgesia
8. Safety: The nature and frequency of adverse events and laboratory and ECG abnormalities
9. Key pharmacokinetics parameters

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Acacia Pharma Limited

Sponsor organisation

Acacia Pharma Limited

Address

3rd Floor, 1 Ashley Road 1 Ashley Road

City

Altrincham

Postcode

WA14 2DT

Country

United Kingdom

Scientific contact point

Organisation

Acacia Pharma Limited

Contact name

Clinical Trials Information

Public contact point

Organisation

Acacia Pharma Limited

Contact name

Clinical Trials Information

Third parties 4

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications