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"

Active, not recruiting

Phase 3 Results N/A

Update History

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.
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The overall status was removed for Merz investigational site #049172.
A location was updated in Gera.
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The overall status was removed for Merz Investigational Site #049335.
A location was updated in Haag i.OB.
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The overall status was removed for Merz Investigational Site #049337.
A location was updated in Munich.
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The overall status was removed for Merz Investigational Site #049072.
A location was updated in Munich.
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The overall status was removed for Merz Investigational Site #049148.
A location was updated in Nümbrecht.
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The overall status was removed for Merz Investigational Site #049300.
A location was updated in Regensburg.
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The overall status was removed for Merz Investigational Site #049303.
A location was updated in Stadtroda.
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The overall status was removed for Merz investigational site #049348.
A location was updated in Ulm.
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The overall status was removed for Merz Investigational Site #049143.
A location was updated in Wolfach.
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The overall status was removed for Merz Investigational Site #049333.
A location was updated in Wuerzburg.
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The overall status was removed for Merz Investigational Site #049302.
A location was updated in Bydgoszcz.
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The overall status was removed for Merz investigational site #048068.
A location was updated in Bydgoszcz.
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The overall status was removed for Merz Investigational Site #048088.
A location was updated in Gdansk.
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The overall status was removed for Merz Investigational Site #048029.
A location was updated in Gdansk.
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The overall status was removed for Merz investigational site #048074.
A location was updated in Jaworzno.
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The overall status was removed for Merz investigational site #048078.
A location was updated in Katowice.
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The overall status was removed for Merz investigational site #048076.
A location was updated in Katowice.
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The overall status was removed for Merz investigational site #048077.
A location was updated in Kielce.
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The overall status was removed for Merz investigational Site #048067.
A location was updated in Krakow.
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The overall status was removed for Merz Investigational Site #048031.
A location was updated in Krakow.
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The overall status was removed for Merz investigational site #048059.
A location was updated in Krakow.
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The overall status was removed for Merz Investigational Site #048087.
A location was updated in Lodz.
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The overall status was removed for Merz Investigational Site #048022.
A location was updated in Lublin.
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The overall status was removed for Merz investigational site #048070.
A location was updated in Lublin.
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The overall status was removed for Merz investigational site #048085.
A location was updated in Lubon.
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The overall status was removed for Merz investigational site #048072.
A location was updated in Sandomierz.
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The overall status was removed for Merz Investigational Site #048075.
A location was updated in Torun.
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The overall status was removed for Merz Investigational Site #048086.
A location was updated in Warszawa.
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The overall status was removed for Merz investigational site #048056.
A location was updated in Warszawa.
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The overall status was removed for Merz investigational site #048064.
A location was updated in Warszawa.
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The overall status was removed for Merz investigational site #048065.
28 May '15
A location was updated in Lublin.
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The overall status was updated to "Withdrawn" at Merz investigational site #048083.
5 Dec '14
A location was updated in Katowice.
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The overall status was updated to "Withdrawn" at Merz investigational site #048073.
A location was updated in Konstancin.
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The overall status was updated to "Withdrawn" at Merz investigational site #048079.
A location was updated in Lodz.
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The overall status was updated to "Withdrawn" at Merz investigational site #048071.
A location was updated in Warszawa.
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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.