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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
ClinicalTrials.gov Identifier:
NCT02116348
First received: April 15, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Locations
Egypt
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
Investigators
Principal Investigator: Sahar M.A. Hassanein, MD, PhD Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University
  More Information

Additional Information:
No publications provided

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
Cerebrolysin
Sleep questionnaire
Quality of life
Bayley III scale

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

ClinicalTrials.gov processed this record on July 23, 2014