Clinical Trials Register

Summary
EudraCT Number:	2011-003646-41
Sponsor's Protocol Code Number:
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-11-24
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Austria - BASG

A.2

EudraCT number

2011-003646-41

A.3

Full title of the trial

Pilotstudy: randomized, open label, single-center study to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Pilotstudy: application of botulinumtoxin A (Xeomin®) to investigate the efficacy and safety of NT 201 for the prophylaxis of relapse after advancement of the mandible

Pilotstudie: Die Anwendung von Botulinumtoxin A (Xeomin®) zur Rezidivprophylaxe bei Unterkiefervorverlagerungen

A.4.1

Sponsor's protocol code number

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Oliver Ploder MD, DDS, PhD
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Merz Pharma Austria GmbH
B.4.2	Country	Austria
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Oliver Ploder MD, DDS, PhD
B.5.2	Functional name of contact point	LKH Feldkirch
B.5.3	Address:
B.5.3.1	Street Address	Carinagasse 47
B.5.3.2	Town/ city	Feldkirch
B.5.3.3	Post code	6800
B.5.3.4	Country	Austria
B.5.4	Telephone number	+435522 303 15 01
B.5.5	Fax number	+435522303 7552
B.5.6	E-mail	oliver.ploder@lkhf.at

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Xeomin
D.2.1.1.2	Name of the Marketing Authorisation holder	Merz Pharmaceuticals GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Austria
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Xeomin
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

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.

E.1.1.1

Medical condition in easily understood language

The study will observe if BTX-A can avoid the relapse.

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

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.

E.2.2

Secondary objectives of the trial

All secondary variables (changes in SNB angle etc. ) will be analyzed descriptively.

E.2.3

Trial contains a sub-study

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

E.4

Principal exclusion criteria

If patients do not meet inclusion criteria

E.5 End points

E.5.1

Primary end point(s)

Investigation of the SNB angle at each visit

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

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.

E.5.2.1

Timepoint(s) of evaluation of this end point

at the same timepoints as the primary end point

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

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

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-11-24.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

at the end of the trial the patient should be healed. If a patient rejects informed consent no negative consequences wether in therapy nor in medical care will occure for this patient. That is also written in the informed consent!

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2016-08-11

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