Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004532-30 | EudraCT Number |
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The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double-blind MP: Placebo (Age 6 to 17 Years) | Experimental | 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. |
|
| Double-blind, MP: NT 201 (Age 6 to 17 Years) | Experimental | 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. |
|
| Open-label, MP: NT 201 (Age 2 to 5 Years) | Experimental | 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. |
|
| OLEX: NT 201 (Age 6 to 17 Years) | Experimental | 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)". |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT 201 Placebo | Drug | NT 201 placebo matching injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | This endpoint was planned to be analyzed in double-blind, MP, 6 to 17 years participants only. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and the procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. | Baseline and Week 4 |
| Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale, with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). | Week 4 |
| Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | Baseline up to Week 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in uSFR at Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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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 #9950003 | K'obulet'i | 6200 | Georgia | |||
| Merz Investigational Site #9950001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34341153 | Result | 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. | |
| 36136523 | Derived | 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. |
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A total of 281 participants were screened, out of which 256 participants were enrolled/randomized into the study. Of these 256 participants, 255 participants received the study treatment. A total of 247 participants who completed the Main Period (MP) entered the Open-label Extension Period (OLEX) of the study.
The study was conducted at 28 investigational sites in Georgia, Hungary, Poland, Russia, Serbia, and Ukraine.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind MP: Placebo (Age 6 to 17 Years) | Participants received 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 were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period (MP) (up to 16 Weeks) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 16, 2016 | Nov 24, 2020 |
Not provided
Not provided
Not provided
Not provided
|
| OLEX: NT 201 (Age 2 to 5 Years) | Experimental | 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 |
| Drug |
NT 201 injection. |
|
|
| Baseline and Weeks 8 and 12 |
| GICS at Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). | Weeks 8 and 12 |
| Occurrence of Treatment Emergent Adverse Events of Special Interest (AESI) Overall and by Injection Cycle | Baseline up to Week 64 |
| Occurrence of Treatment Emergent Serious Adverse Events (TESAEs) Overall and by Injection Cycle | Baseline up to Week 64 |
| Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and by Injection Cycle | Baseline up to Week 64 |
| Occurrence of TEAEs Leading to Discontinuation Overall and by Injection Cycle | Baseline up to Week 64 |
| Tbilisi |
| 0159 |
| Georgia |
| Merz Investigational Site #9950002 | Tbilisi | 0159 | Georgia |
| Merz Investigational Site #0360017 | Balassagyarmat | 2660 | Hungary |
| Merz Investigational Site #0360013 | Budapest | 1083 | Hungary |
| Merz Investigational Site # 0360014 | Budapest | 1125 | Hungary |
| Merz Investigational Site # 0360015 | Budapest | 1125 | Hungary |
| Merz Investigational Site #0360018 | Budapest | 1146 | Hungary |
| Merz Investigational Site #0360016 | Szombathely | 9700 | Hungary |
| Merz Investigational Site #0480092 | Bialystok | 15-274 | Poland |
| Merz Investigational Site #0480090 | Gdansk | 80-952 | Poland |
| Merz Investigational Site #0480076 | Katowice | 40-954 | Poland |
| Merz Investigational Site #0480059 | Krakow | 30-359 | Poland |
| Merz Investigational Site #0480060 | WiÄ…zowna | 05-462 | Poland |
| Merz Investigational Site #0070016 | Kazan' | 420012 | Russia |
| Merz Investigational Site # 0070288 | Kemerovo | 650066 | Russia |
| Merz Investigational Site #0070290 | Khabarovsk | 680038 | Russia |
| Merz Investigational # 0070017 | Saint Petersburg | 194100 | Russia |
| Merz Investigational Site #0070013 | Smolensk | 214018 | Russia |
| Merz Investigational Site # 070019 | Stavropol | 355029 | Russia |
| Merz Investigational Site #0070300 | Tomsk | 634052 | Russia |
| Merz Investigational Site #0070301 | Yekaterinburg | 620149 | Russia |
| Merz Investigational Site #3810001 | Belgrade | 11040 | Serbia |
| Merz Investigational Site #3800001 | Dnipropetrovsk | 49027 | Ukraine |
| Merz Investigational Site #3800012 | Ivano-Frankivsk | 76014 | Ukraine |
| Merz Investigational Site #3800005 | Kharkiv | 61068 | Ukraine |
| Merz Investigational Site #3800007 | Kharkiv | 61153 | Ukraine |
| Merz Investigational Site #3800013 | Kherson | 73010 | Ukraine |
| Merz Investigational site #3800003 | Odesa | 65012 | Ukraine |
| Merz Investigational Site #3800009 | Ternopil | 46020 | Ukraine |
| Merz Investigational Site #3800011 | Zaporizhzhya | 69063 | Ukraine |
| FG001 |
| Double-blind, MP: NT 201 (Age 6 to 17 Years) |
Participants received 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. |
| FG002 | Open-label, MP: NT 201 (Age 2 to 5 Years) | Participants received 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. |
| FG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| FG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| OLEX Period (up to 48 Weeks) |
|
|
The safety evaluable set (SES) (MP) is the subset of all participants who received study medication (NT 201 or placebo) during the MP of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Double-blind MP: Placebo (Age 6 to 17 Years) | Participants received 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 were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm. |
| BG001 | Double-blind, MP: NT 201 (Age 6 to 17 Years) | Participants received NT 201 (up to 2.5 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. |
| BG002 | Open-label, MP: NT 201 (Age 2 to 5 Years) | Participants received 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. |
| 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| 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 | Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4 | This endpoint was planned to be analyzed in double-blind, MP, 6 to 17 years participants only. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and the procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. | The full analysis set (FAS) is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | Posted | Least Squares Mean | Standard Error | gram per minute (g/min) | Baseline and Week 4 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s) | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale, with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | Posted | Least Squares Mean | Standard Error | units on a scale | Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. "n" is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 64 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in uSFR at Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. uSFR was assessed by weighing of absorbent swabs with safety threads soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes. Salivary flow rate was equal to weight increase of swabs/time of collection. The average of the 2 results for flow rate was calculated. The reduction of measured weight over the study relates to improvement of sialorrhea. | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | Posted | Least Squares Mean | Standard Error | g/min | Baseline and Weeks 8 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GICS at Weeks 8 and 12 | This endpoint was analyzed in double-blind, MP, 6 to 17 years participants. The GICS was used to measure the carer's/parent's impression of change due to treatment. The response option was a common 7-point Likert scale with the following values: +3 (very much improved); +2 (much improved); +1 (minimally improved); 0 (no change); -1 (minimally worse); -2 (much worse); -3 (very much worse). | The FAS is identical to the subset of participants in the SES (MP) where subset of all participants received study medication (NT 201 or placebo) during the MP of the study. | Posted | Least Squares Mean | Standard Error | units on a scale | Weeks 8 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Treatment Emergent Adverse Events of Special Interest (AESI) Overall and by Injection Cycle | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. "n" is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 64 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Treatment Emergent Serious Adverse Events (TESAEs) Overall and by Injection Cycle | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. "n" is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 64 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of TEAEs Related to Treatment as Assessed by the Investigator Overall and by Injection Cycle | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. "n" is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 64 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of TEAEs Leading to Discontinuation Overall and by Injection Cycle | SES: subset of all participants who received study medication (NT 201 or placebo) during MP or (NT 201) during OLEX of study. "n" is number of participants evaluable for this measure at a given time period and who were included in the assessment. | Posted | Count of Participants | Participants | Baseline up to Week 64 |
|
Baseline up to Week 64
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 | Double-blind MP: Placebo (Age 6 to 17 Years) | Participants received 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 were matched to the volumes of NT 201 (incobotulinumtoxinA; Xeomin) injected in the experimental arm. | 0 | 72 | 1 | 72 | 3 | 72 |
| EG001 | Double-blind, MP: NT 201 (Age 6 to 17 Years) | Participants received NT 201 (up to 2.5 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. | 0 | 148 | 0 | 148 | 3 | 148 |
| EG002 | Open-label, MP: NT 201 (Age 2 to 5 Years) | Participants received 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. | 0 | 35 | 1 | 35 | 2 | 35 |
| EG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". | 0 | 214 | 8 | 214 | 34 | 214 |
| EG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). | 0 | 33 | 0 | 33 | 12 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Functional gastrointestinal disorder | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Limb deformity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastric operation | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.0 | 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 | Jun 21, 2019 | Nov 24, 2020 | SAP_000.pdf |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D008607 | Intellectual Disability |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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
| Lack of Efficacy |
|
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| Male |
|
| Black or African American |
|
|
|
|
| OG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| OG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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| OG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| OG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
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| OG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| OG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
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| OG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| OG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
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| OG003 | OLEX: NT 201 (Age 6 to 17 Years) | Participants received 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 consisted of participants who participated in MP arms "Double-blind, MP: placebo (age 6 to 17 years)" and "Double-blind, MP: NT 201 (age 6 to 17 years)". |
| OG004 | OLEX: NT 201 (Age 2 to 5 Years) | Participants received 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). |
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