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Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

Primary Purpose

Other Infantile Cerebral Palsy

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Botulinum Toxin Type A(Botox®)

Botulinum toxin type A(Botulax®)

About this trial

This is an interventional treatment trial for Other Infantile Cerebral Palsy focused on measuring Other Infantile Cerebral Palsy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Children patients ages from 2years old to 10years old.
Patients who diagnosed with cerebral palsy.
Patients who diagnosed as Gross Motor Function Classification System level I, II, or III
Patients who diagnosed as dynamic equinus foot deformity
Patients who agree with participation and signed to written agreement by substitute. (Get a signature from children patients if possible)deformity and I, II or III level of Gross Motor Function Classification System

Exclusion Criteria:

Patients who had previous injection of other botulinum toxin products in 3 months
Patients with hypersensitivity history to botulinum toxin products previously
Patients with neuromuscular junction disorder (myasthenia gravis, Lambert- Eaton syndrome, or amyotrophic lateral sclerosis, etc.)
Those who have severe cardiovascular, kidney, liver, or respiratory diseases
Those who are taking anticoagulant drugs or have bleeding disorder.
Pratients with treatment of following drugs: Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen, blockers of parasympathetic nervous system, and levodopa.
Patients who had history of surgery, plan to have surgery on legs, foot, or ankle.
Patients who have evidence of fixed contractures regarding to Investigator
Patients who have difference between two legs over 5cm
Patients with severe athetoid movement
Patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants
Those who were not enrolled in other studies within 30 days, or were not paseed over 5 times of half life for clinical trial drugs.
Patients who have possibility to take prevented drugs
Subjects who are not eligible for this study based on investigator's judgement

Sites / Locations

St. Vincent's hospital
Samsung medical center - Changwon
Keimyung University Dongsan Medical Center
Catholic university of Korea, Daejeon St. Mary's hospital
Samsung medical center - Seoul
The Catholic University of Korea, Seoul St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Botulinum toxin type A (Botulax®)

Botulinum toxin type A(Botox®)

Arm Description

Botulinum toxin type A (Botulax®)

Botulinum toxin type A(Botox®)

Outcomes

Primary Outcome Measures

Rate of patients with an improvement more than two grade in Physician's Rating Scale score.

Secondary Outcome Measures

Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.

Rate of change in Passive range of motion, compare to baseline.

Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.

Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.

Full Information

NCT ID

NCT01787344

First Posted

February 5, 2013

Last Updated

May 1, 2015

Sponsor

Hugel

1. Study Identification

Unique Protocol Identification Number

NCT01787344

Brief Title

Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

Official Title

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy of "Botulax®" Versus "Botox®" in Children With Cerebral Palsy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hugel

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare the safety and efficacy of Botulax Inj.®(Botulinum toxin type A, Hugel, South Korea) with Botox Inj.® (Botulinum toxin type A, Allergan, USA) in the treatment of cerebral palsy in children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Other Infantile Cerebral Palsy

Keywords

Other Infantile Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Botulinum toxin type A (Botulax®)

Arm Type

Experimental

Arm Description

Botulinum toxin type A (Botulax®)

Arm Title

Botulinum toxin type A(Botox®)

Arm Type

Active Comparator

Arm Description

Botulinum toxin type A(Botox®)

Intervention Type

Drug

Intervention Name(s)

Botulinum Toxin Type A(Botox®)

Intervention Description

Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units

Intervention Type

Drug

Intervention Name(s)

Botulinum toxin type A(Botulax®)

Intervention Description

Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units

Primary Outcome Measure Information:

Title

Rate of patients with an improvement more than two grade in Physician's Rating Scale score.

Time Frame

at 12 weeks post-injection

Secondary Outcome Measure Information:

Title

Rate of patients with an improvement more than two grade in Physician's Rating Scale score, comparing to baseline.

Time Frame

at 6 and 24weeks post-injection

Title

Rate of change in Passive range of motion, compare to baseline.

Time Frame

at 6, 12 and 24 weeks post-injection

Title

Rate of change in Gross Motor Function Measure 88, 66, compare to baseline.

Time Frame

at 6, 12 and 24 weeks post-injection

Title

Rate of change in Modified Tardieu Scale(Ankle DF), compare to baseline.

Time Frame

at 6, 12 and 24 weeks post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children patients ages from 2years old to 10years old. Patients who diagnosed with cerebral palsy. Patients who diagnosed as Gross Motor Function Classification System level I, II, or III Patients who diagnosed as dynamic equinus foot deformity Patients who agree with participation and signed to written agreement by substitute. (Get a signature from children patients if possible)deformity and I, II or III level of Gross Motor Function Classification System Exclusion Criteria: Patients who had previous injection of other botulinum toxin products in 3 months Patients with hypersensitivity history to botulinum toxin products previously Patients with neuromuscular junction disorder (myasthenia gravis, Lambert- Eaton syndrome, or amyotrophic lateral sclerosis, etc.) Those who have severe cardiovascular, kidney, liver, or respiratory diseases Those who are taking anticoagulant drugs or have bleeding disorder. Pratients with treatment of following drugs: Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen, blockers of parasympathetic nervous system, and levodopa. Patients who had history of surgery, plan to have surgery on legs, foot, or ankle. Patients who have evidence of fixed contractures regarding to Investigator Patients who have difference between two legs over 5cm Patients with severe athetoid movement Patients who had other treatments related to dynamic equinus foot deformity, such as alcohol injection or muscle relaxants Those who were not enrolled in other studies within 30 days, or were not paseed over 5 times of half life for clinical trial drugs. Patients who have possibility to take prevented drugs Subjects who are not eligible for this study based on investigator's judgement

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeong-yi Kwon, M.D., Ph.D.

Organizational Affiliation

Samsung Medical Center -Seoul

Official's Role

Study Chair

Facility Information:

Facility Name

St. Vincent's hospital

City

Suwon

State/Province

Kyunggi

Country

Korea, Republic of

Facility Name

Samsung medical center - Changwon

City

Changwon

Country

Korea, Republic of

Facility Name

Keimyung University Dongsan Medical Center

City

Daegu

Country

Korea, Republic of

Facility Name

Catholic university of Korea, Daejeon St. Mary's hospital

City

Daejeon

Country

Korea, Republic of

Facility Name

Samsung medical center - Seoul

City

Seoul

Country

Korea, Republic of

Facility Name

The Catholic University of Korea, Seoul St. Mary's hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Phase III Clinical Trial of "Botulax®" to Treat Children With Cerebral Palsy

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