CClinicalTrials.gg
Status unknownNCT02116348Updated Apr 16, 2014

Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy

A Phase 2 interventional study of Cerebrolysin (Nerve growth factor) in Cerebral Palsy Children, Children With Traumatic Brain Injury and Mental Handicap, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2014-04-16.

Sponsored by Ain Shams University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
3 Months to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • 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
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's planned enrollment of 100 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cerebral palsy with mental retardation
  • Severe perinatal brain insult

Exclusion criteria

Exclusion Criteria:

  1. Severe growth retardation
  2. Gastrostomy tube feeding
  3. Intractable seizures.
  4. Severe motor handicap and deformities from long standing spasticity.
  5. Congenital malformations.
  6. Suspected inborn error of metabolism.
  7. Suspected inherited neurologic disease.
  8. Children with auditory and visual impairments.
  9. Care giver's refusal to participate in the study.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Cerebrolysin

    Nerve growth factor Cerebrolysin will be given to the intervention group

    Drug: Cerebrolysin (Nerve growth factor)

  • No intervention
    Conventional

    These children will receive conventional treatment for cerebral palsy

Interventions

  • DrugCerebrolysin (Nerve growth factor)

    Cerebrolysin will be given to the intervention group

    Also known as: Cerebrolysin

06

What researchers measure

Primary outcomes

  1. neurodevelopment

    Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
    Cairo, Abassia 11381, Egypt
    • Mohsen S Elalfy, MD, PhD · Contact · elalfym@hotmail.com
    • Tarek A. Abdo, MD, PhD · Sub investigator
    • Neveen T. Younis, MD, PhD · Sub investigator
    • Iman AA Elagouza, MD, PhD · Sub investigator
    • Shaymaa A Maher, MD, PhD · Sub investigator
    • Eman A.M. Medany, M.SC · Sub investigator
    Recruiting
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02116348
Lead sponsor
Ain Shams University
Responsible party
Sahar M.A. Hassanein, MD (Professor of Pediatrics, Ain Shams University) — Principal investigator
First posted
Apr 16, 2014
Start date
Apr 2014
Primary completion
Apr 2016 (estimated)
Completion
Apr 2016 (estimated)
Last update
Apr 16, 2014

Study contacts

Sahar M.A. Hassanein, MD
Contact
saharhassanein@med.asu.edu.eg
201223183943
Sahar M.A. Hassanein, MD, PhD
principal investigator · Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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