BOTOX® Treatment in Pediatric Upper Limb Spasticity
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01603602 |
|
Recruitment Status :
Completed
First Posted : May 22, 2012
Results First Posted : August 14, 2018
Last Update Posted : August 14, 2018
|
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pediatrics Muscle Spasticity Cerebral Palsy Stroke | Biological: botulinum toxin Type A Drug: Normal Saline (Placebo) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 235 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | BOTOX® Treatment in Pediatric Upper Limb Spasticity: Double-blind Study |
| Actual Study Start Date : | July 12, 2012 |
| Actual Primary Completion Date : | June 29, 2017 |
| Actual Study Completion Date : | July 6, 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: BOTOX® 3 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 3 units (U) per kilogram (kg) of body weight (3 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly occupational therapy (OT).
|
Biological: botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Other Names:
|
|
Experimental: BOTOX® 6 U/kg
Participants received intramuscular injections of BOTOX® (botulinum toxin Type A) 6 U per kg of body weight (6 U/kg) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Biological: botulinum toxin Type A
Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
Other Names:
|
|
Placebo Comparator: Placebo
Participants received intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. Participants received weekly OT.
|
Drug: Normal Saline (Placebo)
Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1. |
Primary Outcome Measures :
- Average Change From Baseline in Modified Ashworth Scale-Bohannon (MAS-B) Score of the Principal Muscle Group at Weeks 4 and 6 [ Time Frame: Baseline (Day 1) to Weeks 4 and 6 ]The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the principal muscle group (elbow and wrist) by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. A Mixed Model Repeated Measures (MMRM) model was used for analysis. A negative change from Baseline indicates improvement.
- Average Clinical Global Impression (CGI) of Overall Change by Physician at Weeks 4 and 6 [ Time Frame: Weeks 4 and 6 ]The CGI of overall change (improvement or worsening) was assessed by the physician considering the participant's clinical condition and severity of side effects using a 9-point scale where: -4=very marked worsening to +4=very marked improvement. The scores at Weeks 4 and 6 were averaged. A MMRM model was used for analysis.
Secondary Outcome Measures :
- Average Change From Baseline in MAS-B Score of the Finger Flexor Muscle Group at Weeks 4 and 6 [ Time Frame: Baseline (Day 1) to Weeks 4 and 6 ]The MAS-B was used to evaluate spasticity based on grading the resistance encountered in the finger flexor muscle group by means of passively moving a limb through its range of motion at a study specified velocity. The resistance encountered to passive stretch was graded using a 6-point scale where: 0=no increase in muscle tone (best) to 4=affected part(s) rigid in flexion or extension (worst). For analysis purposes, the MAS-B was recoded as follows: 0=1, 1=1, 1+=2, 2=3, 3=4, 4=5. The scores at Weeks 4 and 6 were averaged. An Analysis of Covariance (ANCOVA) model was used for analysis. A negative change from Baseline indicates improvement.
- Goal Attainment Score (GAS) as Assessed by Physician Using a 6-Point Scale [ Time Frame: Week 8 and 12 ]Two functional goals, one active and one passive, were selected by the participant and family in consultation with the physician investigator and/or treating physical therapist relative to the lower limb impairment due to spasticity. The physician assessed the achievement of the goals using a 6-point scale: where -3=worse than start to +2=much more than expected: improvements clearly exceed the defined therapeutic goal. An ANCOVA model was used for analysis.
- Change From Baseline in Severity of Spasticity of the Principal Muscle Group (R2-R1) Calculated Using the Modified Tardieu Scale (MTS) [ Time Frame: Baseline (Day 1) to Week 6 ]The MTS measured the difference between slow and fast range of motion (R2-R1) and respective change from baseline to each posttreatment office visit. The MTS of the ankle was used to determine the passive range of movement at different movement velocities, V1 (as slow as possible) and V3 (as fast as possible) with the relative difference between a slow and a fast velocity passive stretch determining the dynamic component of the muscle contracture for the joint. At each visit, the investigator measured 2 joint angles by goniometer: the R1 angle which is the angle of catch after a fast velocity (V3) stretch and the R2 angle defined as the passive joint range of movement following a slow velocity (V1) stretch. The R2 - R1 value indicated the level of the dynamic component of spasticity in the joint. The difference between slow (R2) and fast (R1) range of motion and respective change from baseline to each posttreatment office visit on the MTS was derived.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Minimum weight of 10 kg/22 lb
- Upper limb spasticity due to cerebral palsy or stroke
Exclusion Criteria:
- Muscular dystrophy, myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or mitochondrial disease
- Uncontrolled epilepsy
- Botulinum Toxin therapy of any serotype for any condition within the last 6 months
- Previous surgical treatment of the study limb (except tendon lengthening), or planned surgery of the study limb during the study
- Previous casting of the study limb for spasticity within 6 months or with a dynamic splint within 3 months, or planned casting or dynamic splinting for spasticity of the study limb or affected lower limb during the study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01603602
Locations
Show 45 study locations
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Rozalina Dimitrova | Allergan |
Study Documents (Full-Text)
Documents provided by Allergan:
Documents provided by Allergan:
Study Protocol [PDF] July 22, 2016
Statistical Analysis Plan [PDF] September 11, 2017
Additional Information:
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01603602 |
| Other Study ID Numbers: |
191622-101 2012-000062-38 ( EudraCT Number ) |
| First Posted: | May 22, 2012 Key Record Dates |
| Results First Posted: | August 14, 2018 |
| Last Update Posted: | August 14, 2018 |
| Last Verified: | July 2018 |
Additional relevant MeSH terms:
|
Muscle Spasticity Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Muscular Diseases Musculoskeletal Diseases Muscle Hypertonia Neuromuscular Manifestations Neurologic Manifestations |
Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |