Safety, Tolerability, Analgesic Effect, and Feasibility of Intranasal CT001 in Pediatric Patients

NCT06364072 | Completed Phase 2 Results

• 2 other identifiers: PDC 01-02022023-504023-63-00
• Study Type: interventional
• Target: 155
• Locations: 2 countries
• Sites: 7

Brief Summary

The proposed study aims to investigate the safety, tolerability, analgesic efficacy, and feasibility of intranasal sufentanil/ketamine (CT001) in pediatric participants attending an acute care (i.e. emergency) setting. The study is a part of the clinical development plan for the development of CT001 nasal spray for treatment of acute pain in children.

Conditions

Pain

Outcome Measures

Primary Outcomes (8)

• Sedation

  Sedation was assessed by sedation score on the University of Michigan Sedation Scale (UMSS). Scores range from 0 to 4, where 0 = awake/alert, 1 = minimally sedated (tired/sleepy, appropriate response to verbal conversation and/or sound), 2 = moderately sedated (somnolent/sleeping, easily aroused with light tactile stimulation or simple verbal command), 3 = deeply sedated (deep sleep, arousable only with significant physical stimulation), and 4 = unarousable. Lower scores indicate less sedation; higher scores indicate deeper sedation.

  At baseline and 10, 15, 20, 30, 45 and 60 min after first IMP administration. If a second IMP dose was needed, sedation score was performed at the timepoints relative to first IMP administration.

• Respiratory Depression

  Respiratory depression assessed by respiratory rate.

  At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

• Peripheral Oxygen Saturation

  Peripheral oxygen saturation assessed by oxygen saturation rate (%)

  At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

• Cardiovascular Stability

  Cardiovascular stability assessed by pulse rate (bpm)

  At baseline and 10, 15, 20, 25, 30, 35, 45, 60 and 75 min after IMP administration.

• Number of Reported Adverse Events

  Number of reported adverse events.

  Through study completion; up to 7 days

• Number of Adverse Events (AEs) Reported Per Participant

  Number of adverse events (AEs) reported per participant.

  Through study completion; up to 7 days

• Local Nasal Irritation

  The number of participants with nasal irritation was summarised using counts of participants for each timepoint (30 and 60 min post IMP administration) by type of nasal irritation.

  30 and 60 min post IMP administration

• Analgesic Effect

  Number and proportion of participants that respond to the treatment relative to baseline (i.e. reduction in pain score to 4 or below). Pain intensity was assessed with age-appropriate validated scales. Ages ≥1-\<5years: FLACC (Face, Legs, Activity, Cry, Consolability), total score 0-10 (0=no pain, 10=severe pain). Ages ≥5-\<9years: Wong-Baker FACES, categories 0,2,4,6,8,10 (range 0-10; higher=worse pain). Ages ≥9years: Numerical Rating Scale (NRS) 0-10 (0=no pain, 10=worst pain imaginable).

  At baseline and at 15 and 30 min post first IMP dose

Secondary Outcomes (7)

• Treatment Satisfaction

  Prior to Emergency Department discharge (day of IMP administration)

• Feasibility (Acceptance of Nasal Administration)

  Prior to Emergency Department discharge (day of IMP administration)

• Medication Errors

  Assessed immediately post IMP administration

• Maximum Change From Baseline in Pain Intensity Within 30 Min Post (First) IMP Administration.

  30 min post (first) IMP administration

• Number of Participants That Achieved a 30% (or More) Reduction in Pain Intensity Relative to Baseline

  within 30 min post (first) IMP administration.

Study Arms (1)

CT001

EXPERIMENTAL

Drug: CT001

Interventions

CT001 DRUG

Intranasal

CT001

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric participant, age 1 year to 17 years
• Attending an Emergency Department following an injury
• Acute pain of moderate or severe intensity
• Obtained informed consent by parent/guardian and assent from the child if possible and relevant (age dependent)

You may not qualify if:

• Participant showing abnormal nasal cavity/airway such as:
• major septal deviation
• evidence of previous nasal disease or surgery
• current significant nasal congestion due to common cold
• Has received treatment with sufentanil and/or ketamine during the last 72 hours
• Known or suspected allergy to ketamine or sufentanil
• Critical, life- or limb-threatening condition requiring immediate management

Sponsors & Collaborators

• Cessatech A/S: lead

Study Sites (7)

Hospital General Universitario Dr. Balmis

Alicante, Spain

Location

Hospital Sant Joan de Deu

Barcelona, Spain

Location

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP) -

Madrid, Spain

Location

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, Spain

Location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

Sheffield Children's Hospital

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Martin Juhl
• Organization: Cessatech A/S

martin.juhl@cessatech.com

30833325

Study Officials

• Stuart Hartshorn, Dr.

  Birmingham Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: May 27, 2024
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: February 2, 2026
• Results First Posted: February 2, 2026

Record last verified: 2026-01

Locations

GB (3); ES (4)