Habitual SnoringPhase 2NCT01515371
Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
A Phase 2 study testing IncobotulinumtoxinA in people with Habitual Snoring, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Habitual Snoring
- What is being tested?
- IncobotulinumtoxinA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Nov 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Habitual Snoring
- Being tested
- IncobotulinumtoxinA, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinADrug
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 ComparatorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U | Experimental | 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. Receives: Drug: IncobotulinumtoxinA |
| Placebo Comparator | Placebo comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change from baseline in Snoring Index at week 4
Snoring Index
Measured: Baseline to week 4
Secondary outcomes (3)
Absolute change from baseline in Snoring Index at week 4
Measured: Baseline to week 4
Bed partner satisfaction
Bed partner satisfaction to assess the global effect of the treatment.
Measured: Week 4
Change from baseline in loudness at week 4.
Sone is employed as the unit of the perceived loudness.
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionNov 2012
Why it stopped: Due to lack of sufficient eligible subjects, no safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Habitual SnoringStudies 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study chair, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515371
- Sponsor's protocol ID
- MRZ 60201-2069-1
- Other IDs
- 2011-001779-38
- Status last verified
- Jun 2013
- First submitted
- 18 Jan 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01515371
- Acronym / sponsor ID
- MRZ 60201-2069-1
- Conditions
- Habitual Snoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of sufficient eligible subjects, no safety concerns
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Jan 2012 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U | Experimental | Drug: IncobotulinumtoxinAIncobotulinumtoxinA (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. |
| Placebo Comparator | Placebo comparator | Drug: Placebo ComparatorPlacebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| IncobotulinumtoxinASubject 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. | Drug | IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U |
| Placebo ComparatorFor 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. | Drug | Placebo Comparator |
Primary outcome
Relative change from baseline in Snoring Index at week 4
Time frame: Baseline to week 4
Snoring Index
3 secondary outcomes
Absolute change from baseline in Snoring Index at week 4
Time frame: Baseline to week 4
Bed partner satisfaction
Time frame: Week 4
Change from baseline in loudness at week 4.
Time frame: Baseline to week 4
Results and safety
The study was stopped early (reason given: Due to lack of sufficient eligible subjects, no safety concerns). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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.
Medical Expert study chair
Merz Pharmaceuticals GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IncobotulinumtoxinA in people with Habitual Snoring, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 6 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: stopped early, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Due to lack of sufficient eligible subjects, no safety concerns). Results are not available in the source record.
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?
Relative change from baseline in Snoring Index at week 4 (time frame: Baseline to week 4). 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 19 Jun 2013.