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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2014 by Ain Shams University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
ClinicalTrials.gov Identifier:
First received: April 15, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted

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.

Condition Intervention Phase
Cerebral Palsy Children
Children With Traumatic Brain Injury
Mental Handicap
Delayed Speech Development
Drug: Cerebrolysin (Nerve growth factor)
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • neurodevelopment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy

Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cerebrolysin
Nerve growth factor Cerebrolysin will be given to the intervention group
Drug: Cerebrolysin (Nerve growth factor)
Cerebrolysin will be given to the intervention group
Other Name: Cerebrolysin
No Intervention: Conventional
These children will receive conventional treatment for cerebral palsy


Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02116348

Contact: Sahar M.A. Hassanein, MD 201223183943 saharhassanein@med.asu.edu.eg

Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University Recruiting
Cairo, Abassia, Egypt, 11381
Contact: Mohsen S Elalfy, MD, PhD       elalfym@hotmail.com   
Sub-Investigator: 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         
Sponsors and Collaborators
Ain Shams University
Principal Investigator: Sahar M.A. Hassanein, MD, PhD Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
  More Information

Additional Information:
Responsible Party: Sahar M.A. Hassanein, MD, Professor of Pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT02116348     History of Changes
Other Study ID Numbers: FWA 000017585 
Study First Received: April 15, 2014
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ain Shams University:
Cerebral palsy children
Sleep questionnaire
Quality of life
Bayley III scale

Additional relevant MeSH terms:
Brain Injuries
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Language Development Disorders
Central Nervous System Diseases
Communication Disorders
Craniocerebral Trauma
Language Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016