Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability
NCT ID: NCT02270736
Last Updated: 2021-08-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2015-02-09
2019-05-07
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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Double-blind MP: Placebo (Age 6 to 17 Years)
Participants will receive placebo via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks. Volumes will be matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm.
NT 201 Placebo
NT 201 placebo matching injection.
Double-blind, MP: NT 201 (Age 6 to 17 Years)
Participants will receive NT 201 (up to 2.5 Units per kilogram \[U/kg\] body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
NT 201
NT 201 injection.
Open-label, MP: NT 201 (Age 2 to 5 Years)
Participants will receive NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands in one injection session on Day 1 (Visit 2) of the MP, followed by an observation period of 16 weeks.
NT 201
NT 201 injection.
OLEX: NT 201 (Age 6 to 17 Years)
Participants will receive NT 201 (up to 2.5 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total). This arm will consist of participants who will participate in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)".
NT 201
NT 201 injection.
OLEX: NT 201 (Age 2 to 5 Years)
Participants will receive NT 201 (about 1.5-2 U/kg body weight) via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 of second (Visit 6), third (Visit 10), and fourth (Visit 14) injection cycle of the OLEX, followed by an observation period of 16 weeks each (48 weeks in total).
NT 201
NT 201 injection.
Interventions
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NT 201 Placebo
NT 201 placebo matching injection.
NT 201
NT 201 injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Any neurological disorder (e.g. cerebral palsy or traumatic brain injury) and/or intellectual disability associated with chronic troublesome sialorrhea for at least 3 months up to the screening. In subjects with intellectual disability (ID) without neurological disorders, a diagnosis of ID by a specialist, e.g. pediatrician or by a center for developmental medicine is required for inclusion.
* Severe drooling (modified Teacher´s Drooling Scale \[mTDS\] ≥ 6; clothing occasionally becomes damp) as rated by the investigator.
* Parental consent and the subject's oral or written assent as the subject is able to provide.
Exclusion Criteria
* Body weight \< 12 kg.
* Pharmacological treatment for sialorrhea or concomitant medication known to influence sialorrhea strongly (e.g. anticholinergics with exception of locally applied or short acting drugs used under general anesthesia) within 45 days before baseline and during the entire study period.
* Any previous known or suspected hypersensitivity to Botulinum toxin.
* Aspiration pneumonia within 6 month before screening.
* Any previous treatment with Botulinum toxin for any body region during the year before screening or within the screening period
* Prior, concomitant or planned surgery or irradiation to head and neck to control sialorrhea (including salivary gland surgery or salivary gland irradiation) within one year before screening or planned for any part of the entire study period.
* Concurrent diseases, including hematological, hepatic, renal, gastrointestinal, endocrine, pulmonary, musculoskeletal, or psychiatric diseases or conditions, which in the judgment of the investigator would put the subject at risk while in the study, could influence the results of the study, or negatively impact the subject's ability to participate in the study.
* Extremely poor dental and/or oral condition that might preclude safe study participation by the judgment of the investigator.
* Nursing mother or pregnant female subject.
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 #9950003
K'obulet'i, , Georgia
Merz Investigational Site #9950001
Tbilisi, , Georgia
Merz Investigational Site #9950002
Tbilisi, , Georgia
Merz Investigational Site #0360017
Balassagyarmat, , Hungary
Merz Investigational Site #0360013
Budapest, , Hungary
Merz Investigational Site # 0360014
Budapest, , Hungary
Merz Investigational Site # 0360015
Budapest, , Hungary
Merz Investigational Site #0360018
Budapest, , Hungary
Merz Investigational Site #0360016
Szombathely, , Hungary
Merz Investigational Site #0480092
Bialystok, , Poland
Merz Investigational Site #0480090
Gdansk, , Poland
Merz Investigational Site #0480076
Katowice, , Poland
Merz Investigational Site #0480059
Krakow, , Poland
Merz Investigational Site #0480060
Wiązowna, , Poland
Merz Investigational Site #0070016
Kazan', , Russia
Merz Investigational Site # 0070288
Kemerovo, , Russia
Merz Investigational Site #0070290
Khabarovsk, , Russia
Merz Investigational # 0070017
Saint Petersburg, , Russia
Merz Investigational Site #0070013
Smolensk, , Russia
Merz Investigational Site # 070019
Stavropol, , Russia
Merz Investigational Site #0070300
Tomsk, , Russia
Merz Investigational Site #0070301
Yekaterinburg, , Russia
Merz Investigational Site #3810001
Belgrade, , Serbia
Merz Investigational Site #3800001
Dnipropetrovsk, , Ukraine
Merz Investigational Site #3800012
Ivano-Frankivsk, , Ukraine
Merz Investigational Site #3800005
Kharkiv, , Ukraine
Merz Investigational Site #3800007
Kharkiv, , Ukraine
Merz Investigational Site #3800013
Kherson, , Ukraine
Merz Investigational site #3800003
Odesa, , Ukraine
Merz Investigational Site #3800009
Ternopil, , Ukraine
Merz Investigational Site #3800011
Zaporizhzhya, , Ukraine
Countries
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References
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Berweck S, Bonikowski M, Kim H, Althaus M, Flatau-Baque B, Mueller D, Banach MD. Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children: SIPEXI. Neurology. 2021 Oct 4;97(14):e1425-e1436. doi: 10.1212/WNL.0000000000012573.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-004532-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ60201_3091_1
Identifier Type: -
Identifier Source: org_study_id
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