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.

• Register: EUCTR
• Last refreshed on: 2 October 2017
• Main ID: EUCTR2012-005539-10-DE
• Date of registration: 18/12/2013
• Prospective Registration: Yes
• Primary sponsor: Merz Pharmaceuticals GmbH
• Public title: 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.
• Scientific title: Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation
• Date of first enrolment: 29/04/2014
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005539-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: dose controlled Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Germany, Poland, United States

Contacts

• Affiliation: Merz Pharmaceuticals GmbH

• Affiliation: Merz Pharmaceuticals GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Documented diagnosis of the basic neurological condition associated with sialorrhea (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 ; A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and a score of at least 2 points for each item of the DSFS and 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury.
MedDRA version: 18.1 Level: PT Classification code 10039424 Term: Salivary hypersecretion System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Xeomin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: NT 101
CAS Number: 93384-43-1
Current Sponsor code: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intraglandular use

Trade Name: Xeomin
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: NT 101
CAS Number: 93384-43-1
Current Sponsor code: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Powder for solution for injection
Route of administration of the placebo: Intraglandular use

Primary Outcome(s)

Main Objective: The objective of this study is to investigate the efficacy and safety of two different dose levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a result of various neurological conditions in adult subjects.

Secondary Objective: not applicable

Primary end point(s): Unstimulated salivary flow rate:Change from baseline to week 4; Subject's GICS entry (rating on the Global Impression of Change Scale; or carer's GICS entry, if the subject is not able to answer): week 4.

Timepoint(s) of evaluation of this end point: 4 weeks after first injection

Secondary Outcome(s)

Secondary end point(s): Unstimulated salivary flow rate: Change from baseline to weeks 8 and 12. Subject's GICS entry (or carer's GICS entry, if the subject is not able to answer):weeks 1, 2, 8 and 12.

Timepoint(s) of evaluation of this end point: Weeks 1, 2, 8 and 12

Secondary ID(s)

MRZ60201_3090_1

NCT02091739

Source(s) of Monetary Support

Merz Pharmaceuticals GmbH