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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02091739
Other study ID # MRZ60201_3090_1
Secondary ID 2012-005539-10
Status Completed
Phase Phase 3
First received March 18, 2014
Last updated February 27, 2018
Start date April 2014
Est. completion date November 2016

Study information

Verified date January 2018
Source Merz Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date November 2016
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Intervention

Drug:
IncobotulinumtoxinA (100 Units)
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
IncobotulinumtoxinA (75 Units)
Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Locations

Country Name City State
Germany Merz investigational site #049172 Bonn
Germany Merz Investigational Site #049335 Gera
Germany Merz Investigational Site #049337 Haag i.OB
Germany Merz Investigational Site #049072 Munich
Germany Merz Investigational Site #049148 Munich
Germany Merz Investigational Site #049300 Nümbrecht
Germany Merz Investigational Site #049303 Regensburg
Germany Merz investigational site #049348 Stadtroda
Germany Merz Investigational Site #049143 Ulm
Germany Merz Investigational Site #049333 Wolfach
Germany Merz Investigational Site #049302 Wuerzburg
Poland Merz investigational site #048068 Bydgoszcz
Poland Merz Investigational Site #048088 Bydgoszcz
Poland Merz Investigational Site #048029 Gdansk
Poland Merz investigational site #048074 Gdansk
Poland Merz investigational site #048078 Jaworzno
Poland Merz investigational site #048076 Katowice
Poland Merz investigational site #048077 Katowice
Poland Merz investigational Site #048067 Kielce
Poland Merz investigational site #048031 Krakow
Poland Merz investigational site #048059 Krakow
Poland Merz Investigational Site #048087 Krakow
Poland Merz Investigational Site #048022 Lodz
Poland Merz investigational site #048070 Lublin
Poland Merz investigational site #048085 Lublin
Poland Merz investigational site #048072 Lubon
Poland Merz Investigational Site #048075 Sandomierz
Poland Merz Investigational Site #048086 Torun
Poland Merz investigational site #048056 Warszawa
Poland Merz investigational site #048064 Warszawa
Poland Merz investigational site #048065 Warszawa

Sponsors (1)

Lead Sponsor Collaborator
Merz Pharmaceuticals GmbH

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated. Baseline and Week 4
Primary MP: Participant's Global Impression of Change Scale (GICS) at Week 4 The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank. Week 4
Secondary MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated. Baseline, Week 8 and 12
Secondary MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank. Week 1, 2, 8, and 12
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