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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Respiratory
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014