Clinical Trials Register

Summary
EudraCT Number:	2013-000078-30
Sponsor's Protocol Code Number:	MB0612/1860/02
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-02-20
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-000078-30

A.3

Full title of the trial

Evaluation in patients affected by middle of the night (MONT) awakenings using different dosages of triazolam

Valutazione in pazienti con risveglio intra-sonno di differenti dosaggi di triazolam

A.3.1

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

Evaluation in patients with sleeping disturbances using different dosages of triazolam

Valutazione in pazienti con disturbi del sonno di dosi diverse di triazolam

A.4.1

Sponsor's protocol code number

MB0612/1860/02

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	Valeas SpA
B.1.3.4	Country	Italy
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	Valeas SpA
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Valeas SpA
B.5.2	Functional name of contact point	Medical Direction
B.5.3	Address:
B.5.3.1	Street Address	Via Vallisneri, 10
B.5.3.2	Town/ city	Milan
B.5.3.3	Post code	20133
B.5.3.4	Country	Italy
B.5.4	Telephone number	+392236901
B.5.5	Fax number	+3922367500
B.5.6	E-mail	dir.medica@valeas.it

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	Songar 0,375 mg/ml gocce orali, soluzione
D.2.1.1.2	Name of the Marketing Authorisation holder	Valeas S.p.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.4	Pharmaceutical form	Oral drops, solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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

Insomnia characterized by difficulty returning to sleep following a nocturnal awakening, otherwise called middle-of-the-night (MONT) insomnia

Disturbo da risveglio intra-sonno (night-time awakening) ma senza difficoltà di addormentamento

E.1.1.1

Medical condition in easily understood language

Night-time awakening followed by a difficult to fall asleep

Risveglio notturno con difficoltà a riaddormentarsi

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10029448
E.1.2	Term	Nocturnal awakening
E.1.2	System Organ Class	100000004873

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the efficacy of different triazolam dosage in patients affected by difficulty returning to sleep following a nocturnal awakening

Valutare l’efficacia di diversi dosaggi di Triazolam in pazienti senza difficoltà di addormentamento, ma affetti da risveglio intra-sonno (nighttime awakening)

E.2.2

Secondary objectives of the trial

To evaluate the next morning residual effects of triazolam

Valutare i possibili effetti di triazolam al risveglio mattutino in termini di vigilanza e performance attentiva

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Night-time awakening (>= 5 nights/week) followed by a difficult to fall asleep in men or female aged over 18 years.
- Latency to sleep after the night-time awakening: > 45 minutes
- No difficult to fall asleep at the evening (Sleep Latency < 30 minutes)
- Moderate use of alcool (max 2 glasses of wine/day), caffeine (not after 5 pm and max 2 cups/day) e nicotine (max 10 cigarettes/day)
- No pregnancy, if woman

- Pazienti di entrambi i sessi di età ≥ 18 anni
- Pazienti con risveglio notturno, dopo 1-4 h dall’addormentamento, per almeno 45’ in almeno 5 notti su 7 (dato anamnestico)
- Sleep Latency < 30’ (dato anamnestico)
- Alcol: uso moderato (max 2 bicchieri di vino/die)
- Caffeina: non dopo le 17:00 e al massimo 2 tazzine/die
- Nicotina: max 10 sigarette/die
- Test di gravidanza negativ

E.4

Principal exclusion criteria

- obstructive sleep apnoea syndrome (OSA),
- restless leg syndrome
- shift worker
- any pathology influncing the sleep
- psychiatric disorder according to ASSE 1 – DSM IV-TR
- known hyperseitivity to triazolam
- use of any central nervous system medication or other medications known to affect the sleep/wake function (washout at least of 7 days)

- sindrome delle apnee morfeiche (es. OSA),
- sindrome delle gambe senza riposo,
- condizione medica che possa condizionare il sonno
- turnista
- disturbi psichiatrici secondo ASSE 1 – DSM IV-TR
- allergie o intolleranze ai trattamenti
- farmaci che possano interferire con il ritmo sonno-veglia (wash out di almeno 7 giorni)

E.5 End points

E.5.1

Primary end point(s)

To evaluate the efficacy of different triazolam dosage

Valutare l'efficacia di diversi dosaggi di triazolam

E.5.1.1

Timepoint(s) of evaluation of this end point

Each morning.

Ogni mattina.

E.5.2

Secondary end point(s)

To evaluate the next morning residual effects of triazolam

Valutare i possibili effetti di triazolam al risveglio mattutino in termini di vigilanza e performance attentiva

E.5.2.1

Timepoint(s) of evaluation of this end point

each morning and every week with the vigilance tests

Ogni mattina ed ogni settimana con i test di vigilanza

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)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

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

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

dosi differenti di triazolam

different dosages of triazolam

E.8.2.4

Number of treatment arms in the trial

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.8.5

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 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 2013-02-20.

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)

none

nessuno

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

2013-03-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-05-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-02-11

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials