Brain InjuriesPhase 3NCT04499755
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
A Phase 3 study testing Nucleo CMP Forte in people with Brain Injuries, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Nucleo CMP Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 10 Dec 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with traumatic brain injury: Moderate and Severe.
Who cannot join
- Underlying CNS disorders,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta
Sherief Abd-Elsalam, Ass. Prof., 00201009221243, sheriefabdelsalam@yahoo.com
About this study
Official title: Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial
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
- Conditions
- Brain Injuries
- Being tested
- Nucleo CMP Forte
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nucleo CMP ForteDrug
Also called Nucleoforte
Nucleo CMP Forte twice daily for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Nucleo CMP forte | Experimental | Nucleo CMP forte twice daily for 6 weeks with supportive treatment. Receives: Drug: Nucleo CMP Forte |
| Supportive treatment | No intervention | Supportive treatment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improved glasgow coma score
The number of patients with improved glasgow coma score
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion10 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Abeer Salamah, Lecturer, Principal investigator, Pediatrics department - Kafr-Elsheikh UniversityMohamed Elbahnasawy, lecturer, Principal investigator, Emergency Department- Tanta University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499755
- Sponsor's protocol ID
- KFS protocol
- Status last verified
- Aug 2020
- First submitted
- 1 Aug 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04499755
- Acronym / sponsor ID
- KFS protocol
- Conditions
- Brain Injuries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 10 Dec 2030 (estimated)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Detailed description
The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nucleo CMP forte | Experimental | Drug: Nucleo CMP ForteNucleo CMP forte twice daily for 6 weeks with supportive treatment. |
| Supportive treatment | No intervention | –Supportive treatment only. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with traumatic brain injury: Moderate and Severe.
Key exclusion criteria (1 listed)
- Underlying CNS disorders,
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 |
|---|---|---|
| Nucleo CMP ForteAlso: NucleoforteNucleo CMP Forte twice daily for 6 weeks | Drug | Nucleo CMP forte |
Primary outcome
Number of patients with improved glasgow coma score
Time frame: 2 months
The number of patients with improved glasgow coma score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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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.
Abeer Salamah, Lecturer principal investigator
Pediatrics department - Kafr-Elsheikh University
Mohamed Elbahnasawy, lecturer principal investigator
Emergency Department- Tanta University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nucleo CMP Forte in people with Brain Injuries, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improved glasgow coma score (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.