Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions "SIAXI"

Completed

Phase 3 Results

Update History

16 Feb '18
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition as assessed by a qualified dentist. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.
Old
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition as assessed by a qualified dentist. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.
1 Oct '15
The eligibility criteria were updated.
New
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition as assessed by a qualified dentist. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.
Old
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition as assessed by a qualified dentist. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.
28 Aug '15
A location was updated in Bonn.
New
The overall status was removed for Merz investigational site #049172.
A location was updated in Gera.
New
The overall status was removed for Merz Investigational Site #049335.
A location was updated in Haag i.OB.
New
The overall status was removed for Merz Investigational Site #049337.
A location was updated in Munich.
New
The overall status was removed for Merz Investigational Site #049072.
A location was updated in Munich.
New
The overall status was removed for Merz Investigational Site #049148.
A location was updated in Nümbrecht.
New
The overall status was removed for Merz Investigational Site #049300.
A location was updated in Regensburg.
New
The overall status was removed for Merz Investigational Site #049303.
A location was updated in Stadtroda.
New
The overall status was removed for Merz investigational site #049348.
A location was updated in Ulm.
New
The overall status was removed for Merz Investigational Site #049143.
A location was updated in Wolfach.
New
The overall status was removed for Merz Investigational Site #049333.
A location was updated in Wuerzburg.
New
The overall status was removed for Merz Investigational Site #049302.
A location was updated in Bydgoszcz.
New
The overall status was removed for Merz investigational site #048068.
A location was updated in Bydgoszcz.
New
The overall status was removed for Merz Investigational Site #048088.
A location was updated in Gdansk.
New
The overall status was removed for Merz Investigational Site #048029.
A location was updated in Gdansk.
New
The overall status was removed for Merz investigational site #048074.
A location was updated in Jaworzno.
New
The overall status was removed for Merz investigational site #048078.
A location was updated in Katowice.
New
The overall status was removed for Merz investigational site #048076.
A location was updated in Katowice.
New
The overall status was removed for Merz investigational site #048077.
A location was updated in Kielce.
New
The overall status was removed for Merz investigational Site #048067.
A location was updated in Krakow.
New
The overall status was removed for Merz Investigational Site #048031.
A location was updated in Krakow.
New
The overall status was removed for Merz investigational site #048059.
A location was updated in Krakow.
New
The overall status was removed for Merz Investigational Site #048087.
A location was updated in Lodz.
New
The overall status was removed for Merz Investigational Site #048022.
A location was updated in Lublin.
New
The overall status was removed for Merz investigational site #048070.
A location was updated in Lublin.
New
The overall status was removed for Merz investigational site #048085.
A location was updated in Lubon.
New
The overall status was removed for Merz investigational site #048072.
A location was updated in Sandomierz.
New
The overall status was removed for Merz Investigational Site #048075.
A location was updated in Torun.
New
The overall status was removed for Merz Investigational Site #048086.
A location was updated in Warszawa.
New
The overall status was removed for Merz investigational site #048056.
A location was updated in Warszawa.
New
The overall status was removed for Merz investigational site #048064.
A location was updated in Warszawa.
New
The overall status was removed for Merz investigational site #048065.
28 May '15
A location was updated in Lublin.
New
The overall status was updated to "Withdrawn" at Merz investigational site #048083.
5 Dec '14
A location was updated in Katowice.
New
The overall status was updated to "Withdrawn" at Merz investigational site #048073.
A location was updated in Konstancin.
New
The overall status was updated to "Withdrawn" at Merz investigational site #048079.
A location was updated in Lodz.
New
The overall status was updated to "Withdrawn" at Merz investigational site #048071.
A location was updated in Warszawa.
New
The overall status was updated to "Withdrawn" at Merz Investigational Site #048033.
6 Nov '14
Trial acronym was updated.
New
SIAXI
The eligibility criteria were updated.
New
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain injury (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry, i.e. screening, and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition as assessed by a qualified dentist. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.
Old
Inclusion Criteria: - Documented diagnosis of the basic neurological condition associated with sialorrhea (as above, (i), (ii) or (iii); with onset at least 6 months before screening). - Chronic troublesome sialorrhea (for at least 3 months) at screening, defined as the presence of all of the following, at screening and at baseline and for at least the 3 months before screening (where retrospective response to questionnaires is impossible, a statement of equivalent severity will suffice): 1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and 2. A score of at least 2 points for each item of the DSFS and 3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for Parkinson's Disease [mROMP], Section 'III Drooling', Item A). - A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and a score of at most 3 points on Item C), at screening and at baseline. Exclusion Criteria: - Non-neurological secondary causes of sialorrhea. - Unstable concomitant medication influencing sialorrhea (such as anticholinergics for the treatment of parkinsonism; dosages of these medications must have been stable for at least 4 weeks before study entry and must be planned to remain stable during the course of the study. - Recent (i.e., four weeks) drug treatment for sialorrhea. - History of recurrent aspiration pneumonia. - Extremely poor dental/oral condition. - Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any ingredient of the study preparation. - Recent (i.e., four weeks) changes in anti-parkinsonian medication. - Previous or planned surgery or irradiation to control sialorrhea.