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

Parkinson's Disease Clinical Trial

— SIAXI  

Official 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

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
• 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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Chronic Troublesome Sialorrhea
• Parkinson Disease
• Parkinson's Disease
• Post-stroke
• Sialorrhea
• Traumatic Brain Injury

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