E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Snoring lasting for more than three months and the subject actively seeks for medical help |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10041235 |
E.1.2 | Term | Snoring |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study is to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for the treatment of habitual snoring.
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E.2.2 | Secondary objectives of the trial |
The secondary objective of this study is to evaluate the safety and efficacy of up to 3 different doses of NT 201 after single unilateral injection into the soft palate for the treatment of habitual snoring.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 V2
- Subjects with a bed partner for at least the last three months prior to study start
- Subjects who understand the nature of the study and provide written Informed Consent [IC] at screening visit V1.
- 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
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E.4 | Principal exclusion criteria |
- Obese subjects (Body Mass Index ≥ 30)
- Subjects with severe obstructive sleep apnea syndrome [OSAS]
- Subjects with Apnea-Hypopnea Index [AHI] ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index [RDI] ≥ 25 / hour of sleep at the baseline visit V2
- 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Relative change from baseline in Snoring Index at week 4 after injection
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Absolute change from baseline in Snoring Index at week 4 after injection, Bed partner satisfaction, Change from baseline in loudness at week 4.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study will be defined as the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |