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

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Main period (1 treatment cycle): Subjects to receive placebo injection. Extension period (3 treatment cycles): Subjects will be randomized to receive either 75 or 100 Units IncobotulinumtoxinA per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)
  • IncobotulinumtoxinA (100 Units) Drug
    Other Names: Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: IncobotulinumtoxinA (Xeomin) (100 Units)
    Description: Main period (1 treatment cycle): Subjects to receive 100 Units. Extension period (3 treatment cycles): Subjects to receive 100 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)
  • IncobotulinumtoxinA (75 Units) Drug
    Other Names: Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
    Intervention Desc: 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).
    ARM 1: Kind: Experimental
    Label: IncobotulinumtoxinA (Xeomin) (75 Units)
    Description: Main period (1 treatment cycle): Subjects to receive 75 Units. Extension period (3 treatment cycles): Subjects to receive 75 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Unstimulated salivary flow rate (uSFR) Baseline to week 4 No
Primary Subject's Global Impression of Change Scale (GICS) entry Week 4 No
Secondary Unstimulated salivary flow rate Baseline up to week 12 No

Sponsors