Clinical Trials Register

Summary
EudraCT Number:	2015-001489-24
Sponsor's Protocol Code Number:	PSt012015
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2015-07-29
Trial results	View 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

Germany - BfArM

A.2

EudraCT number

2015-001489-24

A.3

Full title of the trial

Prospective, controlled, randomized, investigator-masked, mul-ticenter, phase III trial to demonstrate the efficacy and safety of Brimonidine UD

Prospektive, kontrollierte, randomisierte, Prüfer-maskierte, multizentrische Phase III Studie zum Nachweis der Wirksamkeit und Sicherheit von Brimonidin UD

A.3.1

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

Prospective, controlled, randomized, investigator-masked, multicenter, phase III trial
In this trial, data to demonstrate the efficacy and safety of Brimonidine UD is generated. Subjects either use Brimonidine UD or a control drug. The drugs are assigned randomly. The investigators generating the data are not aware of which drug a subject they are treating received. Investigations are carried out at multiple trial sites (doctor’s offices or hospitals).

Die klinische Prüfung wird durchgeführt, um Ergebnisse zu generieren, anhand derer die Wirksamkeit und Sicherheit von Brimonidin UD nachgewiesen werden kann. Die Patienten wenden entweder Brimonidin UD oder ein Kontrollpräparat an. Die Zuteilung des Präparates erfolgt zufällig. Die Prüfung findet an mehreren Arztpraxen bzw. Kliniken statt. Die Ärzte, die an den Patienten die Untersuchungen zur Wirksamkeit und Sicherheit durchführen, wissen nicht, welches Präparat einem Patienten zugeteilt wird.

A.4.1

Sponsor's protocol code number

PSt012015

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	Pharma Stulln GmbH
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Pharma Stulln GmbH
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	SAM GmbH
B.5.2	Functional name of contact point	Dr. Werdier
B.5.3	Address:
B.5.3.1	Street Address	Am Gut Wolf 3
B.5.3.2	Town/ city	Aachen
B.5.3.3	Post code	52066
B.5.3.4	Country	Germany
B.5.4	Telephone number	00492418882103
B.5.5	Fax number	00492418882100
B.5.6	E-mail	werdier@sam-germany.de

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	No
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	Brimonidine UD
D.3.4	Pharmaceutical form	Eye drops, solution in single-dose container
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BRIMONIDINTARTRAT
D.3.9.1	CAS number	18109-81-4
D.3.9.4	EV Substance Code	SUB13122MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Alphagan
D.2.1.1.2	Name of the Marketing Authorisation holder	Allergan Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Alphagan
D.3.2	Product code	Alphagan
D.3.4	Pharmaceutical form	Eye drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Ocular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BRIMONIDINTARTRAT
D.3.9.1	CAS number	18109-81-4
D.3.9.4	EV Substance Code	SUB13122MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.3	Concentration number	2
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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

open angle glaucoma, elevated intraocular pressure

Offenwinkelglaukom, erhöhter Augeninnendruck

E.1.1.1

Medical condition in easily understood language

open angle glaucoma, elevated intraocular pressure

Offenwinkelglaukom, erhöhter Augeninnendruck

E.1.1.2

Therapeutic area

Diseases [C] - Eye Diseases [C11]

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 objective of this trial is to demonstrate the efficacy and safety of Brimonidine UD in the reduction of elevated intraocular pressure that can be treated by monotherapy with eye drops containing 1.3 mg/ml brimonidine as the active ingredient.

Nachweis der Wirksamkeit und Sicherheit von Brimonidin UD bezüglich der Reduktion erhöhten Augeninnendrucks, welcher mit einer Monotherapie mit Augentropfen, die 1,3 mg/ml Brimonidin als aktive Substanz enthalten, behandelt werden kann.

E.2.2

Secondary objectives of the trial

Not applicable

Nicht verfügbar

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male subjects and female subjects who cannot become pregnant and female subjects of child bearing potential who use an effective contraceptive method.
2. Subject is at least 18 years old.
3. Subject suffers from open angle glaucoma or from ocular hypertension.
4. The condition named in 3. has not been treated pharmacologically before.
5. IOP ≥ 22 mm Hg and ≤ 30 mm Hg
6. Subjects who have been informed about the clinical trial and have signed the informed consent form.

1. Männliche Probanden und weibliche Probandinnen, die nicht schwanger werden können und weibliche Probandinnen mit der Möglichkeit schwanger zu werden, die eine wirksame kontrazeptive Methode anwenden.
2. Proband(in) ab einem Alter von 18 Jahren.
3. Proband(in) leidet an einem Offenwinkelglaukom oder erhöhtem Augeninnendruck.
4. Die Erkrankung, die in 3. Genannt wird, wurde bisher nicht pharmakologisch behandelt.
5. IOP ≥ 22 mm Hg und ≤ 30 mm Hg.
6. Proband(in) wurden über die klinische Studie aufgeklärt und haben eine Einwilligungserklärung unterschrieben.

E.4

Principal exclusion criteria

1. Eye diseases (except for the ones named in inclusion crite-rion 3) which require treatment.
2. IOP > 30 mm Hg
3. Ocular irritations (e. g. edema, redness) at screening.
4. Ocular inflammation or present effects of previous eye dis-eases which could influence the results of IOP measure-ments.
5. Other glaucoma or ocular hypertension treatment during the trial.
6. Eye surgery 3 month or less prior to screening.
7. Concomitant therapy with monoamine oxidase (MAO) inhibitors or with antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin).
8. Severe or unstable and uncontrolled cardiovascular conditions
9. Severe systemic concomitant diseases
10. Liver or kidney diseases.
11. Scheduled major surgeries.
12. Enrolment in another clinical trial within the last 4 weeks or during enrolment in this trial.
13. Known hypersensitivity to the active ingredient or any excipient of the IMPs.
14. Women: pregnancy or lactation.
15. Previous or current alcohol or drug abuse.
16. Mental or emotional instability that might jeopardize the validity of the informed consent or the compliance with the trial procedures.
17. Unreliability or lack of cooperation.
18. Other reasons why, in the opinion of the investigator, the subjects should not participate in the trial.

1. Augenerkrankungen, die eine Behandlung erfordern (ausgenommen die Erkrankungen, die unter Einschlusskriterien Nr. 3 genannt sind)
2. Augeninnendruck > 30 mmHg
3. Augenirritationen (z.B. Ödem, Rötung) beim Screening
4. Augenentzündung oder gegenwärtige Auswirkungen einer Augenerkrankung, die die Ergebnisse der Augeninnendruckmessung beeinflussen könnte
5. Andere Behandlung eines Glaukoms oder Augeninnendrucks während der Studie
6. Augenoperation innerhalb der letzten 3 Monate vor dem Screening
7. Gegenwärtige Behandlung mit Monoamino Oxidase Hemmer (MAO) oder Antidepressiva, die sich auf die noradrenergische Übertragung auswirken (z.B. trizyklische Antidepressiva und Mianserin)
8. Schwere oder instabile und unkontrollierte kardiovaskuläre Erkrankungen
9. Schwere systemische Begleiterkrankungen
10. Leber- oder Nierenerkrankungen
11. Geplante große Operation
12. Teilnahme an einer klinischen Studie innerhalb der letzten 4 Wochen oder während der Teilnahme an dieser Studie
13. Bekannte Hypersensitivität gegenüber der aktiven Wirkstoffe oder einer der anderen Inhaltsstoffe des IMP
14. Frauen: Schwangerschaft oder Stillzeit
15. Früherer oder derzeitiger Alkohol- oder Drogenmissbrauch
16. Mentale oder emotionale Instabilität, die die Gültigkeit der Einwilligungserklärung oder die Befolgung der Studienprozedur gefährdet
17. Unzuverlässigkeit und Mangel an Kooperation
18. Andere Gründe, die im Ermessen des Prüfarztes eine Teilnahme des Patienten/ der Patientin an der Studie ausschließen

E.5 End points

E.5.1

Primary end point(s)

Reduction of intraocular pressure

Reduktion des Augeninnendrucks

E.5.1.1

Timepoint(s) of evaluation of this end point

Days 1, 15, and 21

Tage 1, 15, und 21

E.5.2

Secondary end point(s)

Safety: ocular irriation; adverse events, overall safety assessment by subject, overall safety assessment by investigator

Sicherheit: Augenirritationen, Unerwünschte Ereignisse, Gesamt Sicherheitsbeurteilung der Probanden und des Prüfarztes

E.5.2.1

Timepoint(s) of evaluation of this end point

Days 1, 15, and 21

Tage 1, 15, und 21

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

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)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Alphagan

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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.1.3.1

Number of subjects for this age range:

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

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)

After a subject has ended his participation in the trial, the investigator has to make sure the subject receives adequate treatment for the open angle glaucoma or ocular hypertension the subject suffers from. The investigator has to provide the treatment, or he has to send the subject to another ophthalmologist who provides the treatment.

Nachdem ein(e) Proband(in) die Teilnahme an der Studie beendet hat, muss der Prüfer sicherstellen, dass der/die Proband(in) eine adäquate Behandlung des Offenwinkelglaukoms oder des erhöhten Augeninnendruckes erhält. Der Prüfer muss die Behandlung durchführen, oder den/die Proband(in) an einen anderen Ophtalmologen überweisen, der die Behandlung durchführt.

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

2015-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-11-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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