NCT04499755

Brief Summary

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
56mo left

Started Jun 2020

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jun 2020Dec 2030

Study Start

First participant enrolled

June 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2030

Last Updated

August 5, 2020

Status Verified

August 1, 2020

Enrollment Period

10.5 years

First QC Date

August 1, 2020

Last Update Submit

August 1, 2020

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

  • Number of patients with improved glasgow coma score

    The number of patients with improved glasgow coma score

    2 months

Study Arms (2)

Nucleo CMP forte

EXPERIMENTAL

Nucleo CMP forte twice daily for 6 weeks with supportive treatment.

Drug: Nucleo CMP Forte

Supportive treatment

NO INTERVENTION

Supportive treatment only.

Interventions

Nucleo CMP ForteDRUG

Nucleo CMP Forte twice daily for 6 weeks

Also known as: Nucleoforte
Nucleo CMP forte

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with traumatic brain injury: Moderate and Severe.

You may not qualify if:

  • Underlying CNS disorders,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Abeer Salamah, Lecturer

    Pediatrics department - Kafr-Elsheikh University

    PRINCIPAL INVESTIGATOR

  • Mohamed Elbahnasawy, lecturer

    Emergency Department- Tanta University.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 5, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 10, 2030

Last Updated

August 5, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)