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"

Completed

Phase 3 Results

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
Primary MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4 Baseline and Week 4
Primary MP: Participant's Global Impression of Change Scale (GICS) at Week 4 Week 4
Secondary MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12 Baseline, Week 8 and 12
Secondary MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12 Week 1, 2, 8, and 12

Sponsors