Cerebrolysin Neural Repair Therapy in Children With Traum... | NCT02116348

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

NCT02116348

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Apr 16, 2014Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Cerebral Palsy Children
Children With Traumatic Brain Injury
Mental Handicap
Delayed Speech Development

Interventions

Cerebrolysin (Nerve growth factor)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Apr 2016Estimated

Completion Date

Apr 2016Estimated

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2014

Last Update Posted Date

Apr 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sahar M.A. Hassanein, MD, Professor of Pediatrics, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cerebrolysin (Nerve growth factor)	Drug	Cerebrolysin will be given to the intervention group	Cerebrolysin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
neurodevelopment	Intelligence quotient (IQ) assessment at base line and after 3 and 6 month of therapy	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cerebral palsy with mental retardation
Severe perinatal brain insult

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sahar M.A. Hassanein, MD	Contact	201223183943		saharhassanein@med.asu.edu.eg

Overall Officials

Name	Affiliation	Role
Sahar M.A. Hassanein, MD, PhD	Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatric Department, Children's Hospital, Faculty of Medicine, Ain Shams University	Recruiting	Cairo	Abassia	11381	Egypt

References Module

Citations

Not provided

Label	URL
Faculty of Medicine, Ain Shams University	View source
Ain Shams University web site	View source

ID	Term
D007806	Language Disorders
D003147	Communication Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations

ID	Term
C006952	cerebrolysin
D020932	Nerve Growth Factor

ID	Term
D009414	Nerve Growth Factors
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins