Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring

NCT01515371 | Terminated Phase 2 DMC

• 2 other identifiers: MRZ 60201-2069-12011-001779-38
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.

Conditions

Habitual Snoring

Outcome Measures

Primary Outcomes (1)

• Relative change from baseline in Snoring Index at week 4

  Snoring Index

  Baseline to week 4

Secondary Outcomes (3)

• Absolute change from baseline in Snoring Index at week 4

  Baseline to week 4

• Bed partner satisfaction

  Week 4

• Change from baseline in loudness at week 4.

  Baseline to week 4

Study Arms (2)

IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U

EXPERIMENTAL

IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.

Drug: IncobotulinumtoxinA

Placebo Comparator

PLACEBO COMPARATOR

Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.

Drug: Placebo Comparator

Interventions

IncobotulinumtoxinA DRUG

Subject to receive one injection of either 2.5U, 5U or 7.4U of IncobotulinumtoxinA. For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per 50U vial, respectively, resulting in a concentration of 6.25 U/ml, 12.5 U/ml and 18.5 U/ml. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.

IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U

Placebo Comparator DRUG

For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per vial, respectively. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male subjects aged 18-70
• Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
• Subjects with a peak Snoring Index \[SI\] ≥ 15/ hour of sleep \[h\] at baseline visit
• Subjects with a bed partner for at least three months prior to study start.
• Subjects who understand the nature of the study and provide written Informed Consent at screening visit.
• Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study

You may not qualify if:

• Obese subjects (Body Mass Index ≥ 30)
• Subjects with severe obstructive sleep apnea syndrome
• Subjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit
• Subjects who have undergone any Botulinum neurotoxin treatment in the history
• Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
• Acute infections of the pharynx

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (1)

Merz Investigational Site #049294

Regensburg, 93053, Germany

Location

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Medical Expert

  Merz Pharmaceuticals GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 24, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 19, 2013

Record last verified: 2013-06

Locations

DE (1)