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

Cerebral Palsy Children Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02116348
• Other study ID #: FWA 000017585
• Status: Recruiting
• Phase: Phase 2
• First received: April 15, 2014
• Last updated: April 15, 2014
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2014
• Source: Ain Shams University
• Contact: Sahar M.A. Hassanein, MD
• Phone: 201223183943
• Email: saharhassanein[@]med.asu.edu.eg
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cerebrolysin (Nerve growth factor)
Cerebrolysin will be given to the intervention group

Locations

Country	Name	City	State
Egypt	Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo	Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurodevelopment	Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy	6 months	No

External Links

•   Ain Shams University web site
•   Faculty of Medicine, Ain Shams University