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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
184
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).
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).
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
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
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.
Time frame: Baseline and Week 4
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.
Time frame: Week 4
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.
Time frame: Baseline, Week 8 and 12
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.
Time frame: Week 1, 2, 8, and 12
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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
...and 21 more locations