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RecruitingNCT04499755Updated Aug 5, 2020

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

A Phase 3 interventional study of Nucleo CMP Forte in Brain Injuries, sponsored by Sherief Abd-Elsalam. Recruiting at 1 site in Egypt. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by Sherief Abd-Elsalam · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study summary

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Read the detailed description

The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

02

Conditions studied

  • Brain Injuries

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03

In context

Brain Injuries

946 studies on the registry are indexed under Brain Injuries; 235 are open to participants now.

This study's planned enrollment of 100 is above the median of 41 across 612 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Sherief Abd-Elsalam is the lead sponsor of 50 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children with traumatic brain injury: Moderate and Severe.

Exclusion criteria

Exclusion Criteria:

  • Underlying CNS disorders,
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Nucleo CMP forte

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

    Drug: Nucleo CMP Forte

  • No intervention
    Supportive treatment

    Supportive treatment only.

Interventions

  • DrugNucleo CMP Forte

    Nucleo CMP Forte twice daily for 6 weeks

    Also known as: Nucleoforte

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What researchers measure

Primary outcomes

  1. Number of patients with improved glasgow coma score

    The number of patients with improved glasgow coma score

    Time frame: 2 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2020 (actual). Primary completion is estimated for Dec 2030, 126 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2020
First posted
Aug 5, 2020
StartActual
Jun 1, 2020
Primary completionEst.
Dec 1, 2030
CompletionEst.
Dec 10, 2030
Last update
Aug 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04499755
Lead sponsor
Sherief Abd-Elsalam
Responsible party
Sherief Abd-Elsalam (Ass. Prof. Tropical Medicine, Tanta University) — Sponsor-investigator
First posted
Aug 5, 2020
Start date
Jun 1, 2020
Primary completion
Dec 1, 2030 (estimated)
Completion
Dec 10, 2030 (estimated)
Last update
Aug 5, 2020

Study contacts

Sherief Abd-Elsalam, ass. prof.
Contact
sheriefabdelsalam@yahoo.com
00201147773440
Abeer Salamah, Lecturer
principal investigator · Pediatrics department - Kafr-Elsheikh University
Mohamed Elbahnasawy, lecturer
principal investigator · Emergency Department- Tanta University.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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