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

NCT02116348 | Unknown Phase 2 DMC

• 1 other identifier: FWA 000017585
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• neurodevelopment

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

  6 months

Study Arms (2)

Cerebrolysin

EXPERIMENTAL

Nerve growth factor Cerebrolysin will be given to the intervention group

Drug: Cerebrolysin (Nerve growth factor)

Conventional

NO INTERVENTION

These children will receive conventional treatment for cerebral palsy

Interventions

Cerebrolysin (Nerve growth factor) DRUG

Cerebrolysin will be given to the intervention group

Also known as: Cerebrolysin

Cerebrolysin

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Cerebral palsy with mental retardation
• Severe perinatal brain insult

You may not qualify if:

• Severe growth retardation
• Gastrostomy tube feeding
• Intractable seizures.
• Severe motor handicap and deformities from long standing spasticity.
• Congenital malformations.
• Suspected inborn error of metabolism.
• Suspected inherited neurologic disease.
• Children with auditory and visual impairments.
• Care giver's refusal to participate in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

Cairo, Abassia, 11381, Egypt

RECRUITING

Related Links

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

MeSH Terms

Conditions

Language Development Disorders

Interventions

cerebrolysin; Nerve Growth Factor

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Growth Factors; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Nerve Tissue Proteins; Biological Factors

Study Officials

• Sahar M.A. Hassanein, MD, PhD

  Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sahar M.A. Hassanein, MD

CONTACT

201223183943; saharhassanein@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

EG (1)