Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders

NCT00773591 | Withdrawn Phase 2

• 1 other identifier: MRZ 60201 SB_2001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.

Conditions

Sleep-Disordered Breathing

Keywords

Sleep-related breathing disorders; Snoring

Outcome Measures

Primary Outcomes (1)

• Comparison of the ratio of snoring time over sleeping time (Snoring Index)

  Snoring Index measured from baseline to follow-up visit and to V3.

Secondary Outcomes (1)

• Change in ventilation (oral/nasal flow) from V0 to V2 and from V0 to V3 including: → Peakflow Vmax → Tidal volume (Vt)

  Change in several Secondary variables from baseline over time

Study Arms (2)

Botulinum Toxin Typ A

ACTIVE COMPARATOR

Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins

Placebo

PLACEBO COMPARATOR

Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins

Interventions

NT 201, a Botulinum neurotoxin type A, free of complexing proteins DRUG

NT 201: Solution for injection, one dose of 5 U will be administered. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge. Placebo: Solution for injection, Dose n.a.; identical injected volume as active study medication. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.

Botulinum Toxin Typ A; Placebo

Eligibility Criteria

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

You may qualify if:

• Male and female outpatients of at least 18 years of age.
• Patient who understand the nature of the study and provide written informed consent prior to protocol-specific procedures.
• Patients suffering from sleep-related breathing disorders for at least 3 months prior to study start and seeking help for their snoring.
• Non-REM RDI ≤ 25/h (according to Medicare Criteria) at baseline PSG.
• AHI ≤ 10/h at baseline PSG.
• Snoring Index ≥ 15 at baseline PSG.

You may not qualify if:

• Patients with known hypersensitivity to:
• botulinum neurotoxin type;
• any of the excipients (human albumin, sucrose).
• Patients with upper respiratory tract pathology as assessed by an ear, nose, and throat \[ENT\] specialist.
• Patients with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
• Patients with bleeding disorders of any type and/or receiving anticoagulant therapy.
• Patients with a profound sleep disorder (pathological number and duration of episodes of hypopnea and apnea), upper airway resistance syndrome \[UARS\], or obstructive sleep apnea syndrome \[OSAS\].
• Obese patients (BMI ≥ 30).
• Presence of concomitant diseases:
• severe or unstable cardiovascular (e.g. severe angina pectoris, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically relevant renal or hepatic disease or dysfunction; hematological disorder; any other clinically relevant medical condition that could increase the risk to the study participant;
• malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer;
• amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction;
• risk of developing an angle closure glaucoma;
• alcohol, drug, or medication abuse within the past year;
• severe psychiatric or neurological disorders;

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

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

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 30, 2015

Record last verified: 2015-03