Status:
WITHDRAWN
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Sleep-Disordered Breathing
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
Detailed Description
Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group. Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- acute infections of the pharynx.
- Patients likely to need concomitant medication as follows:
- 4-aminochinolines;
- aminoglycosides or spectinomycin, or other medical products interfering with neuromuscular transmission, e.g. tubocurarine-type muscle relaxants;
- daily psychotropic medication;
- regular intake or onset of hypnotics, e.g. benzodiazepines, chloralhydrate and combinations, barbiturates (except of mild phytotherapeutics, e.g. valerian, hop and combinations);
- anti-snoring products during the course of the study such as foams, dental devices.
- Pregnant or nursing women, or women of childbearing potential who are not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/ hysterectomized.
- Participation in a clinical study within the last 30 days prior to the start of the study.
- Patients who are employees, relative or spouse of the investigator, of other staff of the investigational site or the sponsor or the CRO.
- Any donation of germ cells, blood, organs, or bone marrow during the course of the study.
- Patients who are expected to be non-compliant and/or not cooperative.
- Patients who are not contractually capable.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00773591
Start Date
March 1 2010
End Date
October 1 2010
Last Update
March 30 2015
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