Sleep-Disordered BreathingPhase 2SnoringNCT00773591
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders
A Phase 2 study testing NT 201, a Botulinum neurotoxin type A, free of complexing proteins in people with Sleep-Disordered Breathing, run by Merz Pharmaceuticals GmbH.
Trial summary
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-Disordered Breathing
- What is being tested?
- NT 201, a Botulinum neurotoxin type A, free of complexing proteins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Oct 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
Read the 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. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.
Primary variable:
Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed.
- Conditions
- Sleep-Disordered Breathing
- Being tested
- NT 201, a Botulinum neurotoxin type A, free of complexing proteins
- Keywords
- Sleep-related breathing disorders, Snoring
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201, a Botulinum neurotoxin type A, free of complexing proteinsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Typ A | Active comparator | Not described Receives: Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins |
| Placebo | Placebo comparator | Not described Receives: Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the ratio of snoring time over sleeping time (Snoring Index)
Measured: 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)
Measured: Change in several Secondary variables from baseline over time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startMar 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Why it stopped: The BfArM (CA)approved the trial in Nov 2008. However, the responsible EC refused approval in March 2009.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-Disordered BreathingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773591
- Sponsor's protocol ID
- MRZ 60201 SB_2001
- Acronym
- Snoring
- Status last verified
- Mar 2015
- First submitted
- 15 Oct 2008
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)
- ClinicalTrials.gov ID
- NCT00773591
- Acronym / sponsor ID
- Snoring / MRZ 60201 SB_2001
- Conditions
- Sleep-Disordered Breathing
- Keywords
- Sleep-related breathing disorders, Snoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The BfArM (CA)approved the trial in Nov 2008. However, the responsible EC refused approval in March 2009.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.
Primary variable:
Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (28 listed)
- Patients with known hypersensitivity to:
- 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].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NT 201, a Botulinum neurotoxin type A, free of complexing proteinsNT 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. | Drug | Botulinum Toxin Typ A, Placebo |
Primary outcome
Comparison of the ratio of snoring time over sleeping time (Snoring Index)
Time frame: Snoring Index measured from baseline to follow-up visit and to V3.
1 secondary outcome
Change in ventilation (oral/nasal flow) from V0 to V2 and from V0 to V3 including: → Peakflow Vmax → Tidal volume (Vt)
Time frame: Change in several Secondary variables from baseline over time
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NT 201, a Botulinum neurotoxin type A, free of complexing proteins in people with Sleep-Disordered Breathing, run by Merz Pharmaceuticals GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the ratio of snoring time over sleeping time (Snoring Index) (time frame: Snoring Index measured from baseline to follow-up visit and to V3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.