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

This study has been terminated.
(Due to lack of sufficient eligible subjects, no safety concerns)
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT01515371
First received: January 18, 2012
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Habitual Snoring
Drug: IncobotulinumtoxinA
Drug: Placebo Comparator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-stage Dose-finding Study to Identify a Safe and Effective Dose of NT 201 for Unilateral Injection Into the Soft Palate for Treatment of Habitual Snoring

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Relative change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Snoring Index


Secondary Outcome Measures:
  • Absolute change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
  • Bed partner satisfaction [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Bed partner satisfaction to assess the global effect of the treatment.

  • Change from baseline in loudness at week 4. [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    Sone is employed as the unit of the perceived loudness.


Enrollment: 8
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U
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

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.

Placebo Comparator: Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Drug: Placebo Comparator
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515371

Locations
Germany
Merz Investigational Site #049294
Regensburg, Germany, 93053
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Medical Expert Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01515371     History of Changes
Other Study ID Numbers: MRZ 60201-2069-1, 2011-001779-38
Study First Received: January 18, 2012
Last Updated: June 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014