Cerebral Palsy ChildrenPhase 2NCT02116348
Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy
A Phase 2 study testing Cerebrolysin (Nerve growth factor) in people with Cerebral Palsy Children and Children With Traumatic Brain Injury, run by Ain Shams University at 1 site in Egypt.
Trial summary
Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per… Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap
- What is being tested?
- Cerebrolysin (Nerve growth factor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2014to Apr 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral palsy with mental retardation
- Severe perinatal brain insult
Who cannot join
- Severe growth retardation
- Gastrostomy tube feeding
- Intractable seizures.
- Severe motor handicap and deformities from long standing spasticity.
- Congenital malformations.
- Suspected inborn error of metabolism.
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- Suspected inherited neurologic disease.
- Children with auditory and visual impairments.
- Care giver's refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
Cairo, Abassia, 11381
Mohsen S Elalfy, MD, PhD, elalfym@hotmail.com
Tarek A. Abdo, MD, PhD
About this study
Official title: Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden.
Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.
- Conditions
- Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development
- Being tested
- Cerebrolysin (Nerve growth factor)
- Keywords
- Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrolysin (Nerve growth factor)Drug
Also called Cerebrolysin
Cerebrolysin will be given to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| Cerebrolysin | Experimental | Nerve growth factor Cerebrolysin will be given to the intervention group Receives: Drug: Cerebrolysin (Nerve growth factor) |
| Conventional | No intervention | These children will receive conventional treatment for cerebral palsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurodevelopment
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar M.A. Hassanein, MD, Ain Shams University
- Investigators
- Sahar M.A. Hassanein, MD, PhD, Principal investigator, Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116348
- Sponsor's protocol ID
- FWA 000017585
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nerve Growth Factor (Cerebrolysin) Therapy on Neurodevelopment, Sleep Pattern and Quality of Life in Children With Traumatic Brain Injury and Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02116348
- Acronym / sponsor ID
- FWA 000017585
- Conditions
- Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap, Delayed Speech Development
- Keywords
- Cerebral palsy children, Cerebrolysin, Sleep questionnaire, Quality of life, Bayley III scale
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- 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.
Cerebral palsy (CP) is the most frequent cause of motor handicap among children. The economic burden of CP in USA includes $1.18 billion in direct medical costs, $1.05 billion in direct non-medical costs, and an additional $9.24 billion in indirect costs, for a total cost of $11.5 billion or $921,000 average cost per person. Associated disabilities as mental retardation, delayed speech development add psychological burden of the disease on the family as well as economic burden.
Mental retardation is the major problem in children with cerebral palsy. Improving mental development will have a positive effect on quality of life for the child and his family. Treating associated impairments (mental retardation) with Cerebrolysin will improve mental development and quality of life, and will decrease the economic burden in children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebrolysin | Experimental | Drug: Cerebrolysin (Nerve growth factor)Nerve growth factor Cerebrolysin will be given to the intervention group |
| Conventional | No intervention | –These children will receive conventional treatment for cerebral palsy |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cerebral palsy with mental retardation
- Severe perinatal brain insult
Key exclusion criteria (9 listed)
- Severe growth retardation
- Gastrostomy tube feeding
- Intractable seizures.
- Severe motor handicap and deformities from long standing spasticity.
- Congenital malformations.
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 |
|---|---|---|
| Cerebrolysin (Nerve growth factor)Also: CerebrolysinCerebrolysin will be given to the intervention group | Drug | Cerebrolysin |
Primary outcome
neurodevelopment
Time frame: 6 months
Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Faculty of Medicine, Ain Shams UniversityLink provided by the sponsor.
- Ain Shams University web siteLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Sahar M.A. Hassanein, MD, PhD principal investigator
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cerebrolysin (Nerve growth factor) in people with Cerebral Palsy Children and Children With Traumatic Brain Injury, run by Ain Shams University 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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Apr 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sahar M.A. Hassanein, MD (201223183943, saharhassanein@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neurodevelopment (time frame: 6 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 16 Apr 2014.