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

NCT02116348 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-16

No results posted yet for this 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.

Conditions

  • Cerebral Palsy Children
  • Children With Traumatic Brain Injury
  • Mental Handicap
  • Delayed Speech Development

Interventions

DRUG

Cerebrolysin (Nerve growth factor)

Cerebrolysin will be given to the intervention group

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Sahar M.A. Hassanein, MD, PhD · Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02116348 on ClinicalTrials.gov