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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005496-14 | EudraCT Number |
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The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 Units per kg body weight incobotulinumtoxinA (Xeomin) | Experimental | 8 Units per kg body weight (maximum of 200 Units) will be injected per treated upper limb per injection cycle. Additionally, lower limb treatment may be administered, depending on clinical pattern: up to 300 Units per injection cycle. Overall maximum dose per injection cycle: 500 Units. |
|
| 6 Units per kg body weight incobotulinumtoxinA (Xeomin) | Experimental | 6 Units per kg body weight (maximum of 150 Units) will be injected per treated upper limb per injection cycle. Additionally, lower limb treatment may be administered, depending on clinical pattern: up to 225 Units per injection cycle. Overall maximum dose per injection cycle: 375 Units. |
|
| 2 Units per kg body weight incobotulinumtoxinA (Xeomin) | Experimental | 2 Units per kg body weight (maximum of 50 Units) will be injected per treated upper limb per injection cycle. Additionally, lower limb treatment may be administered, depending on clinical pattern: up to 75 Units per injection cycle. Overall maximum dose per injection cycle: 125 Units. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA (8 Units per kg body weight) | Drug | 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); Mode of administration: intramuscular injection into spastic muscles. |
| Measure | Description | Time Frame |
|---|---|---|
| MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | The AS categorizes severity of spasticity by judging resistance to passive movement. Spasticity was assessed by using the 5-point AS with:0 (no increase in tone); 1 (slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2 (more marked increase in tone, but limb easily flexed); 3 (considerable increase in tone -passive movements difficult); 4 (limb rigid in flexion or extension). Values represent least square (LS) mean differences between baseline and Week 4 resulting from Mixed Model Repeated Measurement (MMRM) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | Baseline and Week 4 |
| Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | The GICS was used to measure independently the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. |
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Inclusion Criteria:
Female or male subject of 2 to 17 years of age (inclusive).
Uni- or bilateral Cerebral Palsy (CP) with clinical need for injections with NT 201 for the treatment of upper limb (UL) spasticity at least unilaterally.
Ashworth Scale (AS) score in the main clinical target patterns in this study:
Clinical need according to the judgment of the investigator in one out of five treatment combinations (A-E, as shown below). AS score must be ≥2 for each target pattern chosen for injection at the Baseline Injection Visit V2.
A. UL(s) treatment only (GMFCS I-V):
A1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
and
Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
or
A2) Bilateral treatment of UL spasticity with equal doses of 8 U/kg BW NT 201 (maximum of 200 U) to each UL. Dose per UL must be distributed between:
At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
and
Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
B. Unilateral UL and unilateral lower limb (LL) treatment (GMFCS I-V):
B1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
and
Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
plus
B2) Ipsilateral unilateral treatment of LL spasticity with 8 U/kg BW NT 201 (maximum of 200 U). Dose to LL must be distributed to at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe as clinically needed.
C. Unilateral UL and bilateral LL treatment (GMFCS I-III)
C1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
and
Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
plus
C2) Bilateral treatment of LL spasticity with 12 U/kg BW (maximum of 300 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.
D. Unilateral UL and bilateral LL treatment (GMFCS IV and V)
D1) Unilateral treatment of UL spasticity with 8 U/kg BW NT 201 (maximum of 200 U) for:
At least one of the main clinical target patterns flexed elbow (4 U/kg BW) and/or flexed wrist (2 U/kg BW).
and
Additional clinical patterns in the same limb (i.e., clenched fist, thumb in palm, and/or pronated forearm) with the remaining units until maximum dose of 8 U/kg BW (maximum of 200 U) for treatment of a single UL is reached.
plus
D2) Bilateral treatment of LL spasticity with 8 U/kg BW (maximum of 200 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.
E. Bilateral UL treatment and bilateral LL treatment (GMFCS I-III)
E1) Bilateral treatment of UL spasticity with equal doses of 8 U/kg BW NT 201 (maximum of 200 U) to each UL. Dose per UL must be distributed between
plus
E2) Bilateral treatment of LL spasticity with 4 U/kg BW (maximum of 100 U). Dose must be distributed into at least one of clinical target patterns pes equinus, flexed knee, adducted thigh, and extended great toe, on each side. Dose distribution may vary between sides as clinically needed.
Exclusion Criteria:
Pre-treated (non-naïve) subjects must not have received BoNT treatment within the last 14 weeks prior to Screening Visit (V1) in any indication.
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| Name | Affiliation | Role |
|---|---|---|
| Merz Medical Expert | Merz Pharmaceuticals GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #001286 | Gulf Breeze | Florida | 32561 | United States | ||
| Merz Investigational Site #001284 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34339951 | Result | Dabrowski E, Chambers HG, Gaebler-Spira D, Banach M, Kanovsky P, Dersch H, Althaus M, Geister TL, Heinen F. IncobotulinumtoxinA Efficacy/Safety in Upper-Limb Spasticity in Pediatric Cerebral Palsy: Randomized Controlled Trial. Pediatr Neurol. 2021 Oct;123:10-20. doi: 10.1016/j.pediatrneurol.2021.05.014. Epub 2021 May 21. | |
| 36136523 |
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A total of 372 participants were screened, 351 participants were randomized and 350 participants were randomized and treated in the study. 331 participants completed the main period (MP) and moved to the open-label-extension period (OLEX) out of which 281 participants completed the OLEX period.
The study was conducted at 28 investigative sites in Mexico, Argentina, Russian federation, Ukraine, United States and Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | MP Low Dose Group | Participants in low dose group received intramuscular injections of 2 Units per kilogram (U/kg) NT 201 (maximum of 50 Units [U] in participants with greater than [>] 25 kilogram [kg] body weight [BW]) into spastic muscles of one of the upper Limb (UL) on Day 1 of MP. If the contralateral UL or one or both lower limb (LL) were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's Gross Motor Function Classification System (GMFCS) level. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period (MP) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 7, 2016 | Jul 13, 2020 |
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|
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| IncobotulinumtoxinA (6 Units per kg body weight) | Drug | 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); Mode of administration: intramuscular injection into spastic muscles. |
|
|
| IncobotulinumtoxinA (2 Units per kg body weight) | Drug | 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); Mode of administration: intramuscular injection into spastic muscles. |
|
|
| Baseline and Week 4 |
| MP: Change From Baseline in AS Score in UL Treated Clenched Fist With Flexed Wrist at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | Baseline and Week 4 |
| MP: Change From Baseline in AS Score for Each Treated Clinical Pattern of the UL at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | Baseline up to Week 4 |
| MP: Change From Baseline in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) Assessed With 'Questionnaire on Pain Caused by Spasticity (QPS)' | 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). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. P/C = Parent/Caregiver. | Baseline, Weeks 4, 8, and 14 |
| MP: Child's/Adolescent's, and Parent's/Caregiver's GICS in UL at Week 4 | The GICS was used to measure independently the child's/adolescent's, and parent's or caregiver's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from: +3(very much improved); +2(much improved); +1(minimally improved); 0(no change); -1(minimally worse); -2(much worse); -3(very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | Week 4 |
| Number of Participants With Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs of Special Interest (TEAESIs) Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of Serious TEAEs (TESAEs) Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs Related to Treatment Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs by Worst Intensity Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs by Worst Causal Relationship Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs by Final Outcome Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Number of Participants With Occurrence of TEAEs Leading to Discontinuation Overall and Per Treatment Cycle | Baseline up to Week 66 |
| Loxahatchee Groves |
| Florida |
| 33470 |
| United States |
| Merz Investigational Site #001285 | Savannah | Georgia | 31405 | United States |
| Merz Investigational Site #001186 | Chicago | Illinois | 60611 | United States |
| Merz Investigational Site No. #001302 | Royal Oak | Michigan | 48073 | United States |
| Merz Investigational Site #001283 | Columbia | Missouri | 65212 | United States |
| Merz Investigational Site #054010 | Godoy Cruz | Mendoza Province | M5501 | Argentina |
| Merz Investigational Site #054005 | Caba | CP 1428 | Argentina |
| Merz Investigational Site #052023 | Aguascalientes | 20127 | Mexico |
| Merz Investigational Site #052003 | Guadalajara | 44280 | Mexico |
| Merz Investigational Site #052024 | Mexico City | 04530 | Mexico |
| Merz Investigational Site #052022 | Mexico City | 06700 | Mexico |
| Merz Investigational Site #052027 | Monterrey | 64060 | Mexico |
| Merz Investigational Site #052028 | Monterrey | 64710 | Mexico |
| Merz Investigational Site #052026 | Zapopan | 45030 | Mexico |
| Merz Investigational Site #048089 | Bialystok | 15-274 | Poland |
| Merz Investigational Site #048063 | Gdansk | 80-389 | Poland |
| Merz Investigational Site #048059 | Krakow | 30-539 | Poland |
| Merz Investigational Site #048084 | Lublin | 20-828 | Poland |
| Merz Investigational Site #048094 | Poznan | 60-480 | Poland |
| Merz Investigational Site #048075 | Sandomierz | 27-600 | Poland |
| Merz Investigational Site #048060 | WiÄ…zowna | 05-462 | Poland |
| Merz Investigational Site #007014 | Kazan' | 420097 | Russia |
| Merz Investigational Site #007015 | Khabarovsk | 680038 | Russia |
| Merz Investigational Site #007018 | Novosibirsk | 630091 | Russia |
| Merz Investigational Site #007298 | Saint Petersburg | 192148 | Russia |
| Merz Investigational Site #007013 | Smolensk | 214019 | Russia |
| Merz Investigational Site #007019 | Stavropol | 355029 | Russia |
| Merz Investigational Site #380001 | Dnipropetrovsk | 49000 | Ukraine |
| Merz Investigational Site #380005 | Kharkiv | 61068 | Ukraine |
| Merz Investigational Site #380002 | Kyiv | 04209 | Ukraine |
| Merz Investigational Site #380003 | Odesa | 65012 | Ukraine |
| 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. |
| FG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| FG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| FG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| Treated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Open-Label Extension Period (OLEX) |
|
|
The analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MP Low Dose Group | Participants in low dose group received intramuscular injections of 2 U/kg NT 201 (maximum of 50 U in participants with >25 kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| BG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| BG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MP: Change From Baseline in Ashworth Scale (AS) in UL Primary Clinical Target Pattern at Week 4 | The AS categorizes severity of spasticity by judging resistance to passive movement. Spasticity was assessed by using the 5-point AS with:0 (no increase in tone); 1 (slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2 (more marked increase in tone, but limb easily flexed); 3 (considerable increase in tone -passive movements difficult); 4 (limb rigid in flexion or extension). Values represent least square (LS) mean differences between baseline and Week 4 resulting from Mixed Model Repeated Measurement (MMRM) models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The full analysis set (FAS) was the subset in the safety evaluation set (SES) of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline and Week 4 |
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| Primary | Co-primary Variable MP: Investigator's Global Impression of Change Scale (GICS) at Week 4 | The GICS was used to measure independently the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available (that is, all participants who had at least an AS score in clinical pattern flexed elbow or flexed wrist at baseline [Day 1] or Investigator's GICS at Day 29 [Week 4]). | Posted | Least Squares Mean | Standard Error | Unit on a scale | Week 4 |
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| Secondary | MP: Change From Baseline in AS Score of the Other Treated UL Main Clinical Target Pattern at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline and Week 4 |
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| Secondary | MP: Change From Baseline in AS Score in UL Treated Clenched Fist With Flexed Wrist at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline and Week 4 |
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| Secondary | MP: Change From Baseline in AS Score for Each Treated Clinical Pattern of the UL at Week 4 | The AS categorizes the severity of spasticity by judging resistance to passive movement. Spasticity was assessed by 5-point scale at visits, where: 0 (no increase in tone); 1(slight increase in tone giving a "catch" when the limb was moved in flexion or extension); 2(more marked increase in tone, but limb easily flexed); 3(considerable increase in tone - passive movements difficult); 4(limb rigid in flexion or extension). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline up to Week 4 |
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| Secondary | MP: Change From Baseline in Scores of Pain Intensity (From Participants) and Pain Frequency (From Parent/Caregiver) Assessed With 'Questionnaire on Pain Caused by Spasticity (QPS)' | 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). Values represent LS mean differences between baseline and Week 4 resulting from MMRM models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. P/C = Parent/Caregiver. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Baseline, Weeks 4, 8, and 14 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | MP: Child's/Adolescent's, and Parent's/Caregiver's GICS in UL at Week 4 | The GICS was used to measure independently the child's/adolescent's, and parent's or caregiver's impression of change due to treatment. The response option was a common 7-point Likert scale, that ranges from: +3(very much improved); +2(much improved); +1(minimally improved); 0(no change); -1(minimally worse); -2(much worse); -3(very much worse). Values represent LS mean differences between baseline and Week 4 resulting from ANCOVA models comparing high versus low and in a second step mid versus low dose groups, respectively. Values for the low group may differ slightly depending on the comparison and are therefore provided separately for each comparison. | The FAS was the subset in the SES of the MP for whom the primary efficacy variable or co-primary efficacy variable were available. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Least Squares Mean | Standard Error | Unit on a scale | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Treatment Cycle | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs of Special Interest (TEAESIs) Overall and Per Treatment Cycle | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of Serious TEAEs (TESAEs) Overall and Per Treatment Cycle | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs Related to Treatment Overall and Per Treatment Cycle | The SES was the subset of all participants treated in MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs by Worst Intensity Overall and Per Treatment Cycle | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs by Worst Causal Relationship Overall and Per Treatment Cycle | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs by Final Outcome Overall and Per Treatment Cycle | The SES were the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Occurrence of TEAEs Leading to Discontinuation Overall and Per Treatment Cycle | The SES was the subset of all participants treated in the MP and OLEX with study medication at least once. Number of participants who were evaluable for this measure at a given time period and were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 66 |
|
Baseline up to Week 66
The investigator asked the participant for adverse events (AEs) systematically at each visit.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MP Low Dose Group | Participants in low dose group received intramuscular injections of 2 U/kg NT 201 (maximum of 50 U in participants with >25 kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 2 U/kg (50 U for participants with >25kg BW) to 5 U/kg (125 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. | 0 | 87 | 2 | 87 | 5 | 87 |
| EG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. | 0 | 87 | 1 | 87 | 3 | 87 |
| EG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. | 0 | 176 | 2 | 176 | 6 | 176 |
| EG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. | 0 | 331 | 16 | 331 | 18 | 331 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| CSF shunt operation | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
| |
| Electroencephalogram | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Spinal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cyclic vomiting syndrome | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Disclosure Manager | Merz Pharmaceuticals GmbH | +49 69 1503 1 | clinicaltrials@merz.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2018 | Jul 13, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
Not provided
Not provided
| Physician Decision |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| White |
|
| Other |
|
| Mid versus low |
|
|
LS-Means are from mixed model with treatment group, pooled site and pre-treatment status included as fixed factors and AS at baseline, GMFCS-E&R level at screening included as covariates. For MMRM visit*treatment is interaction term repeated factor. |
| MMRM |
| = 0.546 |
| LS-Mean difference |
| -0.07 |
| 2-Sided |
| 95 |
| -0.29 |
| 0.15 |
| Superiority |
| OG001 |
| MP Mid Dose Group |
Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
|
| OG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG001 | MP Mid Dose Group | Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| MP Mid Dose Group |
Participants in mid dose group received intramuscular injections of 6 U/kg NT 201 (maximum of 150 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 6 U/kg (150 U for participants with >25kg BW) to 15 U/kg (375 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
|
| OG002 | MP High Dose Group | Participants in high dose group received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of one of the UL on Day 1 of MP. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
| OG003 | OLEX (3 Injections) | Participants who completed MP and qualified for further participation in the study received intramuscular injections of 8 U/kg NT 201 (maximum of 200 U in participants with >25kg BW) into spastic muscles of the UL on Day 1 of each of the three injection cycles of OLEX. If the contralateral UL or one or both LL were also treated, participants received additional doses of NT 201. The total body dose ranged from 8 U/kg (200 U for participants with >25kg BW) to 20 U/kg (500 U for participants with >25kg BW) depending on the combination of treated limbs and the participant's GMFCS level. |
|
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