Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
NCT ID: NCT01893411
Last Updated: 2021-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
311 participants
INTERVENTIONAL
2013-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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16 Units per kg body weight incobotulinumtoxinA (Xeomin)
IncobotulinumtoxinA (16 Units per kg body weight)
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 volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.
12 Units per kg body weight incobotulinumtoxinA (Xeomin)
IncobotulinumtoxinA (12 Units per kg body weight)
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 volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.
4 Units per kg body weight incobotulinumtoxinA (Xeomin)
IncobotulinumtoxinA (4 Units per kg body weight)
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 volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.
Interventions
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IncobotulinumtoxinA (16 Units per kg body weight)
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 volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.
IncobotulinumtoxinA (12 Units per kg body weight)
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 volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.
IncobotulinumtoxinA (4 Units per kg body weight)
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 volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Uni- or bilateral cerebral palsy with clinical need for uni- or bilateral LL injections with BoNT for the treatment of spasticity.
* Ashworth Scale \[AS\] score ≥2 in plantar flexors (at least unilaterally).
* Clinical need for a total dose of 16 U/kg BW NT 201 (maximum of 400 U) for the treatment of LL spasticity according to the clinical judgment of the investigator.
Exclusion Criteria
* Surgery on pes equinus on side(s) intended to be treated with BoNT injections in this study within 12 months prior to Screening Visit (V1), in the screening period or planned for the time of participation in this study.
* Hip flexion requiring BoNT injection.
2 Years
17 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Merz Medical Expert
Role: STUDY_DIRECTOR
Merz Pharmaceuticals GmbH
Locations
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Merz Investigational Site #043037
Graz, , Austria
Merz Investigational Site #043036
Vienna, , Austria
Merz Investigational Site #420029
Brno, , Czechia
Merz Investigational Site #420028
Olomouc, , Czechia
Merz Investigational Site #372001
Tallinn, , Estonia
Merz Investigational Site #372002
Tartu, , Estonia
Merz Investigational Site #033056
Amiens, , France
Merz Investigational Site #033052
Bron, , France
Merz Investigational Site #033054
La Tronche, , France
Merz Investigational Site #033055
Palavas-les-Flots, , France
Merz Investigational Site #049328
Bochum, , Germany
Merz Investigational Site #049330
Marburg, , Germany
Merz Investigational Site #049327
Munich, , Germany
Merz Investigational Site #049329
Münster, , Germany
Merz Investigational Site #049326
Vogtareuth, , Germany
Merz Investigational Site #972003
Jerusalem, , Israel
Merz Investigational Site #972001
Tel Aviv, , Israel
Merz Investigational Site #972002
Tel Aviv, , Israel
Merz Investigational Site #048089
Bialystok, , Poland
Merz Investigational Site #048063
Gdansk, , Poland
Merz Investigational Site #048059
Krakow, , Poland
Merz Investigational Site #048084
Lublin, , Poland
Merz Investigational Site #048072
Luboń, , Poland
Merz Investigational Site #048075
Sandomierz, , Poland
Merz Investigational Site #048061
Warsaw, , Poland
Merz Investigational Site #040003
Bucharest, , Romania
Merz Investigational Site #040001
Bucharest, , Romania
Merz Investigational Site #040002
Iași, , Romania
Merz Investigational Site #007014
Kazan', , Russia
Merz Investigational Site #007015
Khabarovsk, , Russia
Merz Investigational Site #007018
Novosibirsk, , Russia
Merz Investigational Site #007017
Saint Petersburg, , Russia
Merz Investigational Site #007013
Smolensk, , Russia
Merz Investigational Site #007019
Stavropol, , Russia
Merz Investigational Site #421003
Banská Bystrica, , Slovakia
Merz Investigational Site #421008
Bratislava, , Slovakia
Merz Investigational Site #421006
Krompachy, , Slovakia
Merz Investigational Site #421004
Levoča, , Slovakia
Merz Investigational Site #082019
Goyang, , South Korea
Merz Investigational Site #082021
Incheon, , South Korea
Merz Investigational Site #082018
Seongnam-si, , South Korea
Merz Investigational Site #082020
Seoul, , South Korea
Merz Investigational Site #034031
Granada, , Spain
Merz Investigational Site #034032
Manresa, , Spain
Merz Investigational Site #034030
Seville, , Spain
Merz Investigational Site #034026
Seville, , Spain
Merz Investigational Site #090005
Elâzığ, , Turkey (Türkiye)
Merz Investigational Site #090003
Izmir, , Turkey (Türkiye)
Merz Investigational Site #090002
İzmit, , Turkey (Türkiye)
Merz Investigational Site #380001
Dnipropetrovsk, , Ukraine
Merz Investigational Site #380005
Kharkiv, , Ukraine
Merz Investigational Site #380002
Kiev, , Ukraine
Merz Investigational Site #380003
Odesa, , Ukraine
Countries
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References
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Heinen F, Kanovsky P, Schroeder AS, Chambers HG, Dabrowski E, Geister TL, Hanschmann A, Martinez-Torres FJ, Pulte I, Banach M, Gaebler-Spira D. IncobotulinumtoxinA for the treatment of lower-limb spasticity in children and adolescents with cerebral palsy: A phase 3 study. J Pediatr Rehabil Med. 2021;14(2):183-197. doi: 10.3233/PRM-210040.
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.
Other Identifiers
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2012-005054-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ60201_3070_1
Identifier Type: -
Identifier Source: org_study_id
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