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Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy

Primary Purpose

Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IncobotulinumtoxinA (16-20 Units per kg body weight)
Sponsored by
Merz Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Main clinical inclusion criteria for completers of study MRZ60201_3070_1:

  • Subject with lower limb [LL] spasticity who completed lead-in study MRZ60201_3070_1 in any of the three dose groups with duration of both injection cycles between 12 and 16 weeks.
  • Ashworth scale [AS] score ≥2 in plantar flexors (at least unilaterally). For subjects with an AS score of 1, the investigator has to decide on the clinical need for reinjection.
  • Clinical need for spasticity treatment with NT 201 according to the clinical judgment of the investigator for:

Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus and need for additional 8 U/kg BW NT 201 (maximum of 200 U) for treatment of clinical pattern flexed knee or adducted thigh (ipsilateral) or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus on each side.

No treatment of other clinical patterns is allowed.

Main clinical inclusion criteria for subjects who did not participate in MRZ60201_3070_1:

  • Female or male subject of 2 to 17 years age (inclusive).
  • Uni- or bilateral CP with clinical need for BoNT injection to treat limb spasticity.
  • AS score ≥ 2 in plantar flexors (at least unilaterally).
  • Clinical need according to the clinical judgment of the investigator in one out of four treatment combinations:

    1. For LL(s) treatment only (Gross Motor Function Classification System [GMFCS] levels IV): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides).
    2. For combined unilateral UL and unilateral LL, (GMFCS levels I-III): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh plus Unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm.
    3. For combined unilateral UL and unilateral LL (GMFCS level IV-V): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum 200 U) into pes equinus, and 4 U/kg BW NT201 (maximum 100 U) into flexed knee or adducted thigh plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm.
    4. For combined unilateral UL and bilateral LL (GMFCS levels I-III): Bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides) plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm.

Exclusion Criteria:

Exclusion Criteria for subjects who completed MRZ60201_3070_1:

  • Infection and/or inflammation in the area of the planned injection points.
  • Pregnancy for female with history of menarche.
  • Clinically relevant pathological findings indicating active disease of vital organs.

Exclusion Criteria for subjects who did not participate in MRZ60201_3070_1:

  • Fixed contracture defined as severe restriction of the range of joint movement on passive stretch in the target clinical pattern(s) or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s).
  • Surgery in the pes equinus on side(s) intended to treat with BoNT injections within 12 months prior to Screening Visit (V1), within the screening period or planned for the time of participation in this study.
  • Hip flexion requiring BoNT injection.
  • Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30.
  • Vaccination within 2 weeks prior to Screening Visit (V1) and/or within the screening period.
  • Non-resolved fractures of the treated limb.
  • Ventilator dependency.
  • Severe neurological diagnosis and comorbidity outside the spectrum of cerebral palsy.
  • Pure dyskinetic CP or mixed CP with predominantly dyskinetic movements.
  • Treatment with BoNT (other than study drug in this study) for any body region within 14 weeks prior to Screening Visit (V1), within the screening period and/or intended to be administered during the study period.
  • Treatment with phenol or alcohol of any muscle within 6 months prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period.
  • Treatment with

    • drugs acting as peripheral muscle relaxants
    • intrathecal baclofen, or
    • oral anticoagulants administered within 2 weeks prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period.

Sites / Locations

  • Merz Investigational Site #043036
  • Merz Investigational Site #420029
  • Merz Investigational Site #420028
  • Merz Investigational Site #372001
  • Merz Investigational Site #372002
  • Merz Investigational Site #049328
  • Merz Investigational Site #049329
  • Merz Investigational Site #049327
  • Merz Investigational Site #049326
  • Merz Investigational Site #972003
  • Merz Investigational Site #972001
  • Merz Investigational Site #972002
  • Merz Investigational Site #082019
  • Merz Investigational Site #082021
  • Merz Investigational Site #082018
  • Merz Investigational Site #082020
  • Merz Investigational Site #048089
  • Merz Investigational Site #048063
  • Merz Investigational Site #048059
  • Merz Investigational Site #048084
  • Merz Investigational Site #048072
  • Merz Investigational Site #048075
  • Merz Investigational Site #048061
  • Merz Investigational Site #040003
  • Merz Investigational Site #040001
  • Merz Investigational Site #040002
  • Merz Investigational Site #007014
  • Merz Investigational Site #007015
  • Merz Investigational Site #007018
  • Merz Investigational Site #007017
  • Merz Investigational Site #007013
  • Merz Investigational Site #007019
  • Merz Investigational Site #421003
  • Merz Investigational Site #421008
  • Merz Investigational Site #421006
  • Merz Investigational Site #421004
  • Merz Investigational Site #090005
  • Merz Investigational Site #090003
  • Merz Investigational Site #090002
  • Merz Investigational Site #380001
  • Merz Investigational Site #380005
  • Merz Investigational Site #380002
  • Merz Investigational Site #380003

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

16-20 Units per kg body weight incobotulinumtoxinA

Arm Description

Outcomes

Primary Outcome Measures

Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle
TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.
Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle
TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected.
Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle
TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.

Secondary Outcome Measures

Investigator's Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle
The investigator's global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit.
Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle
The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, "primary body side" was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit.
Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle
The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function).
Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle
The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is "primary body side" was decided by investigator at screening and was kept throughout the entire study.
Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle
The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a "catch-and-release" or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.
Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection
The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS total score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS total score for the observed pain frequency ranges from 0 (Never) to 4 (Always). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.
Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study
The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).

Full Information

First Posted
July 18, 2013
Last Updated
September 28, 2017
Sponsor
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01905683
Brief Title
Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy
Official Title
Open-label, Non-controlled, Multicenter Long-term Study to Investigate the Safety and Efficacy of Xeomin® (Incobotulinumtoxin A, NT 201) for the Treatment of Spasticity of the Lower Limb(s) or of Combined Spasticity of Upper and Lower Limb in Children and Adolescents (Age 2 - 17 Years) With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg(s) or of leg(s) and one arm are safe in treating children/adolescents (age 2-17 years) long-term with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb and Combined Lower Limb and Upper Limb Spasticity Due to Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
370 (Actual)

8. Arms, Groups, and Interventions

Arm Title
16-20 Units per kg body weight incobotulinumtoxinA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
IncobotulinumtoxinA (16-20 Units per kg body weight)
Other Intervention Name(s)
Xeomin, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention Description
Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.
Primary Outcome Measure Information:
Title
Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle
Description
TEAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.
Time Frame
From the timepoint of first injection up to end of study visit (Week 50-66)
Title
Occurrence of Treatment Emergent Adverse Events of Special Interest (TEAESI) Overall and Per Injection Cycle
Description
TEAEs occurring after treatment that were thought to possibly indicate toxin spread throughout the trial conduct are defined as TEAESI. Values reported here refer to the number of participants affected.
Time Frame
From the timepoint of first injection until end of study visit (Week 50-66)
Title
Occurrence of Treatment-emergent Serious Adverse Events (TESAEs) Overall and Per Injection Cycle
Description
TESAEs are events observed from the time point of first injection until end of study visit (Week 50-66). Values reported here refer to the number of participants affected.
Time Frame
From the timepoint of first injection until end of study visit (Week 50-66)
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment of Tolerability at Day 99 (Week 14) of Each Injection Cycle
Description
The investigator's global assessment of tolerability was assessed on a 4-point ordinal scale where 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Results for Day 99 (Week 14) of 4th injection cycles were collected at the end of study visit.
Time Frame
Day 99 (Week 14) of 1st, 2nd, 3rd and 4th injection cycle
Title
Changes in AS Score of Left and Right Plantar Flexors (PF) From Baseline to All Other Visits, From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle Only) and Day 99 (Week 14) of the Respective Injection Cycle
Description
The Ashworth Scale (AS) is a well-known and commonly used scale in clinical trials with spasticity. In spastic muscles the resistance to passive movement is assessed. It is a 5-point scale that ranges from 0 (= no increase in tone) to 4 (=limb rigid in flexion or extension). For participants with bilateral pes equinus, the body side for efficacy analysis that is, "primary body side" was decided by investigator at screening and was kept throughout the entire study. V3 = Week 4 of 1st Injection Cycle; V4 = Week 8 of 1st Injection Cycle; V5 = Day 1 of 2nd Injection Cycle; V6= Week 4 of 2nd Injection Cycle; V7 = Day 1 of 3rd Injection Cycle; V8 = Week 4 of 3rd Injection Cycle; V9 = Day 1 of 4th Injection Cycle; V10 = Week 4 of 4th Injection Cycle; V11= Week 14th of 4th Injection Cycle = end of study visit.
Time Frame
Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each Injection Cycle to Day 29 (Week 4), Day 57 (Week 8, 1st Injection Cycle only) and Day 99 (Week 14) of the respective Injection Cycle
Title
Investigator's, Child's/Adolescent's, and Parent's/Caregiver's Global Impression of Change Scale (GICS) at Day 29 (Week 4) of Each Injection Cycle
Description
The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function).
Time Frame
Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle
Title
Investigator's Global Impression of Change of Plantar Flexor Spasticity Scale (GICS-PF) of Left and Right PF at Day 29 (Week 4) of Each Injection Cycle
Description
The GICS are global outcomes to assess the impression of change due to treatment. GICS were assessed by the investigator, by the participant (if feasible) and by parents'/caregiver (if applicable). GICS is a 7-Point Likert Scale ranging from +3 (very much improved function) to -3 (very much worse function). For participants with bilateral pes equinus, the body side for efficacy analysis that is "primary body side" was decided by investigator at screening and was kept throughout the entire study.
Time Frame
Day 29 (Week 4) of 1st, 2nd, 3rd and 4th injection cycle
Title
Changes in Modified Tardieu Scale (MTS) of Left and Right PF From Baseline to All Other Visits, From Day 1 of Each Injection Cycle (IC) to Day 29 (Week 4), Day 57 (Week 8, 1st IC Only) and Day 99 (Week 14) of the Respective Injection Cycle
Description
The MTS assesses spastic muscle tone by subtraction of two angles measured at different conditions of passive muscle stretch. R2 is the angle of passive range of motion with a passive movement at slow speed. R1 is the angle where a "catch-and-release" or clonus can be triggered at the fastest possible speed. Score values represent the measured (R2-R1) difference, that is, the dynamic tone component of the examined muscle(s). Decreases of (R2-R1) represent reductions in the dynamic component of spasticity, that is, improvement of dynamic muscle spasticity. V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5 = Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.
Time Frame
Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC
Title
Change in Scores of Pain Intensity (From Participants) and Frequency (From Parent/Caregiver) From Baseline to All Visits, From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC Cycle Only) and Day 99 (Week 14) of Respective Injection
Description
The questionnaire on pain caused by Spasticity (QPS) is a participant-reported outcome for children and adolescents (2-17 years) with cerebral palsy on spasticity-related pain. Pain intensity (from participants) and pain frequency (from parent/caregiver) to be assessed with QPS. The QPS total score for pain intensity ranges from 0 ('No Hurt') to 10 ('Hurt Worst'). The QPS total score for the observed pain frequency ranges from 0 (Never) to 4 (Always). V3 = Week 4 of 1st IC; V4 = Week 8 of 1st IC; V5= Day 1 of 2nd IC; V6 = Week 4 of 2nd IC; V7 = Day 1 of 3rd IC; V8 = Week 4 of 3rd IC; V9 = Day 1 of 4th IC; V10 = Week 4 of 4th IC; V11 = Week 14 of 4th IC = end of study visit.
Time Frame
Baseline (Day 1, Visit [V] 2) to all other visits (V3, V4, V5, V6, V7, V8, V9, V10, and V11); From Day 1 of Each IC to Day 29 (Week 4), Day 57 (Week 8, 1st IC cycle only) and Day 99 (Week 14) of the respective IC
Title
Changes in Gross Motor Function Measure (GMFM)-66 Score From Baseline to All Injection Visits and End of Study
Description
The GMFM-66 is a standardized observational 66-item instrument designed and validated to measure change in gross motor function over time in participants with cerebral palsy. Score values represent the total GMFM-66 score. Total GMFM scores range from 0 (worst) to 100 (best).
Time Frame
Baseline to Day 1 of 2nd (V5), 3rd (V7), 4th (V9) IC and End of study (Week 44-68) (V11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Main clinical inclusion criteria for completers of study MRZ60201_3070_1: Subject with lower limb [LL] spasticity who completed lead-in study MRZ60201_3070_1 in any of the three dose groups with duration of both injection cycles between 12 and 16 weeks. Ashworth scale [AS] score ≥2 in plantar flexors (at least unilaterally). For subjects with an AS score of 1, the investigator has to decide on the clinical need for reinjection. Clinical need for spasticity treatment with NT 201 according to the clinical judgment of the investigator for: Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus and need for additional 8 U/kg BW NT 201 (maximum of 200 U) for treatment of clinical pattern flexed knee or adducted thigh (ipsilateral) or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus on each side. No treatment of other clinical patterns is allowed. Main clinical inclusion criteria for subjects who did not participate in MRZ60201_3070_1: Female or male subject of 2 to 17 years age (inclusive). Uni- or bilateral CP with clinical need for BoNT injection to treat limb spasticity. AS score ≥ 2 in plantar flexors (at least unilaterally). Clinical need according to the clinical judgment of the investigator in one out of four treatment combinations: For LL(s) treatment only (Gross Motor Function Classification System [GMFCS] levels IV): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh or bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides). For combined unilateral UL and unilateral LL, (GMFCS levels I-III): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into pes equinus, and 8 U/kg BW NT 201 (maximum of 200 U) into flexed knee or adducted thigh plus Unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. For combined unilateral UL and unilateral LL (GMFCS level IV-V): Unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum 200 U) into pes equinus, and 4 U/kg BW NT201 (maximum 100 U) into flexed knee or adducted thigh plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. For combined unilateral UL and bilateral LL (GMFCS levels I-III): Bilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) into each pes equinus (AS score ≥ 2 on both sides) plus unilateral treatment of UL spasticity with 4 U/kg BW NT 201 (maximum of 100 U) into flexed elbow, flexed wrist, clenched fist, thumb in palm and/or pronated forearm. Exclusion Criteria: Exclusion Criteria for subjects who completed MRZ60201_3070_1: Infection and/or inflammation in the area of the planned injection points. Pregnancy for female with history of menarche. Clinically relevant pathological findings indicating active disease of vital organs. Exclusion Criteria for subjects who did not participate in MRZ60201_3070_1: Fixed contracture defined as severe restriction of the range of joint movement on passive stretch in the target clinical pattern(s) or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s). Surgery in the pes equinus on side(s) intended to treat with BoNT injections within 12 months prior to Screening Visit (V1), within the screening period or planned for the time of participation in this study. Hip flexion requiring BoNT injection. Limitation of hip abduction to less than 40° or pre-diagnosed migrational percentage greater than 30. Vaccination within 2 weeks prior to Screening Visit (V1) and/or within the screening period. Non-resolved fractures of the treated limb. Ventilator dependency. Severe neurological diagnosis and comorbidity outside the spectrum of cerebral palsy. Pure dyskinetic CP or mixed CP with predominantly dyskinetic movements. Treatment with BoNT (other than study drug in this study) for any body region within 14 weeks prior to Screening Visit (V1), within the screening period and/or intended to be administered during the study period. Treatment with phenol or alcohol of any muscle within 6 months prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period. Treatment with drugs acting as peripheral muscle relaxants intrathecal baclofen, or oral anticoagulants administered within 2 weeks prior to Screening Visit (V1), within the screening period, and/or intended to be administered during the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merz Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Merz Investigational Site #043036
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Merz Investigational Site #420029
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Merz Investigational Site #420028
City
Olomouc
ZIP/Postal Code
77520
Country
Czechia
Facility Name
Merz Investigational Site #372001
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Merz Investigational Site #372002
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Merz Investigational Site #049328
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Merz Investigational Site #049329
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Merz Investigational Site #049327
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
Merz Investigational Site #049326
City
Vogtareuth
ZIP/Postal Code
83569
Country
Germany
Facility Name
Merz Investigational Site #972003
City
Jerusalem
ZIP/Postal Code
91240
Country
Israel
Facility Name
Merz Investigational Site #972001
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Merz Investigational Site #972002
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Merz Investigational Site #082019
City
Goyang
ZIP/Postal Code
410-773
Country
Korea, Republic of
Facility Name
Merz Investigational Site #082021
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Merz Investigational Site #082018
City
Seongnam-si
ZIP/Postal Code
463-712
Country
Korea, Republic of
Facility Name
Merz Investigational Site #082020
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Merz Investigational Site #048089
City
Bialystok
ZIP/Postal Code
15-274
Country
Poland
Facility Name
Merz Investigational Site #048063
City
Gdansk
ZIP/Postal Code
80-389
Country
Poland
Facility Name
Merz Investigational Site #048059
City
Kraków
ZIP/Postal Code
30-539
Country
Poland
Facility Name
Merz Investigational Site #048084
City
Lublin
ZIP/Postal Code
20-828
Country
Poland
Facility Name
Merz Investigational Site #048072
City
Lubon
ZIP/Postal Code
62-030
Country
Poland
Facility Name
Merz Investigational Site #048075
City
Sandomierz
ZIP/Postal Code
27-600
Country
Poland
Facility Name
Merz Investigational Site #048061
City
Warsaw
ZIP/Postal Code
02-315
Country
Poland
Facility Name
Merz Investigational Site #040003
City
Bucharest
ZIP/Postal Code
041408
Country
Romania
Facility Name
Merz Investigational Site #040001
City
Bucharest
ZIP/Postal Code
041914
Country
Romania
Facility Name
Merz Investigational Site #040002
City
Iasi
ZIP/Postal Code
700309
Country
Romania
Facility Name
Merz Investigational Site #007014
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Merz Investigational Site #007015
City
Khabarovsk
ZIP/Postal Code
680038
Country
Russian Federation
Facility Name
Merz Investigational Site #007018
City
Novosibirsk
ZIP/Postal Code
630091
Country
Russian Federation
Facility Name
Merz Investigational Site #007017
City
Saint-Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Merz Investigational Site #007013
City
Smolensk
ZIP/Postal Code
214029
Country
Russian Federation
Facility Name
Merz Investigational Site #007019
City
Stavropol
ZIP/Postal Code
355029
Country
Russian Federation
Facility Name
Merz Investigational Site #421003
City
Banska Bystrica
ZIP/Postal Code
97409
Country
Slovakia
Facility Name
Merz Investigational Site #421008
City
Bratislava
ZIP/Postal Code
82108
Country
Slovakia
Facility Name
Merz Investigational Site #421006
City
Krompachy
ZIP/Postal Code
05342
Country
Slovakia
Facility Name
Merz Investigational Site #421004
City
Levoca
ZIP/Postal Code
05401
Country
Slovakia
Facility Name
Merz Investigational Site #090005
City
Elazig
ZIP/Postal Code
23119
Country
Turkey
Facility Name
Merz Investigational Site #090003
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Merz Investigational Site #090002
City
Izmit
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Merz Investigational Site #380001
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Merz Investigational Site #380005
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Merz Investigational Site #380002
City
Kiev
ZIP/Postal Code
04209
Country
Ukraine
Facility Name
Merz Investigational Site #380003
City
Odessa
ZIP/Postal Code
65012
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
36136523
Citation
Berweck S, Banach M, Gaebler-Spira D, Chambers HG, Schroeder AS, Geister TL, Althaus M, Hanschmann A, Vacchelli M, Bonfert MV, Heinen F, Dabrowski E. Safety Profile and Lack of Immunogenicity of IncobotulinumtoxinA in Pediatric Spasticity and Sialorrhea: A Pooled Analysis. Toxins (Basel). 2022 Aug 25;14(9):585. doi: 10.3390/toxins14090585.
Results Reference
derived

Learn more about this trial

Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy

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