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

Phase 2

• Conditions: Mental Handicap; Children With Traumatic Brain Injury; Cerebral Palsy Children; Delayed Speech Development
• Interventions: Drug: Cerebrolysin (Nerve growth factor)

• Registration Number: NCT02116348
• Lead Sponsor: Ain Shams University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-04
• Study Start: 2014-04
• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Last Update Submitted: 2014-04-15
• Study First Posted: 2014-04-16
• Last Update Posted: 2014-04-16
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cerebral palsy with mental retardation
• Severe perinatal brain insult

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebrolysin	Cerebrolysin (Nerve growth factor)	Nerve growth factor Cerebrolysin will be given to the intervention group

Primary Outcome Measures

Name	Time	Method
neurodevelopment	6 months	Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy

Trial Locations

Locations (1)

Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Abassia, Egypt