E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The study will analyse the efficacy of BTX-A to avoid a relapse after advancement of the mandible (BSSO – bilateral sagittal split osteotomy) with more than 5 mm. The tension of the muscle complex of the anterior floor of the mouth can cause a relapse of the advancement of the mandible in the follow up. |
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E.1.1.1 | Medical condition in easily understood language |
The study will observe if BTX-A can avoid the relapse. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
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 efficacy variable is the percentage of responders during the study. A responder is defined as: Somebody whose SNB angle between first postoperative and following postoperative radiograph is < 1° (corresponds to less than 1.7 mm relapse). SNB Angle: Sella – Nasion – B-Point Angle. The difference will be measured on standardized radiographs (lateral cephalogram at 1.5 m distance) between first postoperative radiograph (2-3 days postoperatively) and the subsequent radiographs (6, 12 and 24 months postoperatively). In all 3 controls the data has to meet the benchmarks of a responder, otherwise it will be counted as a relapse. |
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E.2.2 | Secondary objectives of the trial |
All secondary variables (changes in SNB angle etc. ) will be analyzed descriptively. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Female or male individuals with mandibular retrognathia, aged ≥ 18 complying with the following main inclusion criteria:
- mandibular retrognathia with more than 5 mm discrepancy, measured via standardized x-ray and measurement methods for orthognathic surgery
- not allergic against BTX-A
- no muscle diseases (eg Myasthenia gravis, Lambert-Eaton-Syndrom) or muscle atrophy
- no infection at the localization of injection
- no taking of anticoagulations
- no pregnancy or breast feeding
- no dysphagia
- written consent
- fully capable
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E.4 | Principal exclusion criteria |
If patients do not meet inclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
Investigation of the SNB angle at each visit |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoint(s) of evaluation of this endpoint difference between 1st week and 6 weeks after surgery and 6, 12 and 24 months after surgery will be measured on standardized radiographs |
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E.5.2 | Secondary end point(s) |
All secondary variables (changes in SNB angle, distance pogonion to postgonion, distance gnathion to condylon, post airway space, muscle belly) will be analyzed descriptively. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the same timepoints as the primary 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 | Yes |
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |