Clinical Trials Register

Summary
EudraCT Number:	2016-002161-56
Sponsor's Protocol Code Number:	NeM-CSM-FT-01
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-08-23
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2016-002161-56

A.3

Full title of the trial

Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy

Badania neuronalnych mechanizmów kompulsywnych zachowań seksualnych - farmakoterapia

A.3.1

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

Towards the understanding of neuronal mechanisms of compulsive sexual behaviors - pharmacotherapy

Badania neuronalnych mechanizmów kompulsywnych zachowań seksualnych - farmakoterapia

A.3.2

Name or abbreviated title of the trial where available

NeM-CSM-FT

A.4.1

Sponsor's protocol code number

NeM-CSM-FT-01

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	Mateusz Gola
B.1.3.4	Country	Poland
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	Mateusz Gola
B.4.2	Country	Poland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Centrum Terapii Lew-Starowicz
B.5.2	Functional name of contact point	Site Registration
B.5.3	Address:
B.5.3.1	Street Address	Nowogrodzka 62c/42
B.5.3.2	Town/ city	Warszawa
B.5.3.3	Post code	02-002
B.5.3.4	Country	Poland
B.5.6	E-mail	centrum@lew-starowicz.pl

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	Parogen
D.2.1.1.2	Name of the Marketing Authorisation holder	Generics [UK] Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Coated tablet
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.IMP: 2
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	Naltrexone Hydrochloride Accord
D.2.1.1.2	Name of the Marketing Authorisation holder	Accord Healthcare Limited
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Natrexone Hydrochloride Accord
D.3.4	Pharmaceutical form	Coated tablet
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

compulsive sexual behavior (hypersexual disorder)

kompulsywne zachowania seksualne (zaburzenie hiperseksualne)

E.1.1.1

Medical condition in easily understood language

compulsive sexual behavior (sex addiction)

kompulsywne zachowania seksualne (uzależnienie od seksu)

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

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

To check if medication applied in accordance with current knowledge on the neuronal mechanisms of compulsive sexual behavior leads to a significant reduction of symptoms of this disorder

sprawdzenie, czy odpowiednio dobrane w oparciu o wiedzę na temat mechanizmów neuronalnych kompulsywnych zachowań seksualnych leczenie farmakologiczne prowadzi do istotnej redukcji objawów tych zaburzeń

E.2.2

Secondary objectives of the trial

Evaluation of the influence of the medication on particular aspects related to compulsive sexual behavior (e.g. behavioral control, impulsivity, frequency of compulsive sexual behavior, mood regulation, brain response to erotic cues)

ocena wpływu zastosowanego leczenia na poszczególne aspekty związane z kompulsywnymi zachowaniami seksualnymi (m.in. kontrola zachowania, impulsywność, częstość kompulsywnych zachowań seksualnych, regulacja nastroju, reakcja mózgu na sygnały erotyczne)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Heterosexual male ≥ 18 years old
2. Signed informed consent
3. Perceived loss of control over one’s sexual behavior (pornography use, masturbation, partnered sexual activity, use of commercial sexual services) causing
4. Help/treatment seeking (psychological/psychiatric/sexological/self-help groups/spiritual counseling)
5. Meeting criteria of Hypersexual Disorder by Kafka (2010) – at least 4 out of 5 (A1-A5):
A1. Time consumed by sexual fantasies, urges or behaviors repetitively interferes with other important (non-sexual) goals, activities and obligations.
A2. Repetitively engaging in sexual fantasies, urges or behaviors in response to dysphoric mood states (e.g., anxiety, depression, boredom, irritability).
A3. Repetitively engaging in sexual fantasies, urges or behaviors in response to stressful life events.
A4. Repetitive but unsuccessful efforts to control or significantly reduce these sexual fantasies, urges or behaviors.
A5. Repetitively engaging in sexual behaviors while disregarding the risk for physical or emotional harm to self or others.
with
B. Significant personal distress or impairment in social, occupational or other important areas of functioning associated with the frequency and intensity of these sexual fantasies, urges or behaviors
C. These sexual fantasies, urges or behaviors are not due to the direct physiological effect of an exogenous substance (e.g., a drug of abuse or a medication)

1. Płeć męska i wiek ≥ 18 lat.
2. Podpisany formularz świadomej zgody na udział w badaniu
3. Subiektywne poczucie utraty kontroli nad własnymi zachowaniami seksualnymi (oglądaniem pornografii, masturbacją, podejmowaniem kontaktów seksualnych, korzystaniem z płatnych usług seksualnych)
4. Poszukiwanie pomocy/terapii z tego powodu (psychologicznej/psychiatrycznej/seksuologicznej/grup samopomocy/poradnictwa duchowego)
5. Spełnienie kryteriów rozpoznania Zaburzenia Hiperseksualnego (Kafka, 2010):
Min. 4 z 5 (A1-A5):
A1. Poświęcanie dużej ilości czasu na fantazje lub zachowania seksualne, notorycznie zaniedbując inne ważne (nie związane z seksem) cele, aktywności i zobowiązania.
A2. Powtarzające się zaangażowanie w zachowania i zachowania lub fantazje seksualne w odpowiedzi na dysforyczne stany emocjonalne (lęk, przygnębienie, znudzenie, poirytowanie).
A3. Powtarzające się zaangażowanie w zachowania i zachowania lub fantazje seksualne w odpowiedzi na stresujące wydarzenia życiowe.
A4. Powtarzające się, ale nieskuteczne próby kontroli lub znacznej redukcji zachowań lub fantazji seksualnych.
A5. Powtarzające się zaangażowanie w zachowania seksualne, przy bagatelizowaniu ryzyka doznania lub zadania innym krzywdy fizycznej albo emocjonalnej.
Oraz
B. W związku z częstotliwością lub intensywnością zachowań i fantazji seksualnych, u pacjenta widoczny jest wysoki poziom stresu, dysfunkcji społecznych, zawodowych lub dysfunkcji obejmujących innych ważny obszar życia.
C. Zachowania i fantazje seksualne nie są bezpośrednim efektem fizjologicznym stosowania substancji zewnętrznych (np. narkotyków lub leków).

E.4

Principal exclusion criteria

1. Concomittant mania, bipolar disorder, psychotic disorders, obsessive-compulsive disorder or cognitive impairment according to ICD-10 diagnostic criteria
2. Current use of any antidepressant, anxiolytic, antipsychotic or mood stabilizing medication
3. Current psychotherapy
4. History of any neurological disease
5. Substance abuse or pathological gambling
6. Medical contraindications for the use of paroxetine or naltrexone hydrochloride (according to medicinal product characteristics)
and (because of planned fMRI examination):
7. Implanted metal, electric or electronic devices (heart pacemaker, insulin pump, metal clips etc.)
8. Claustrophobia
9. Tattoos covering face area

1. Współwystępowanie manii, zaburzenia afektywnego dwubiegunowego, zaburzeń psychotycznych, obsesyjno-kompulsyjnych lub upośledzenie funkcji poznawczych (otępienie, upośledzenie umysłowe) zgodnie z kryteriami ICD-10
2. Aktualne stosowanie leków przeciwdepresyjnych, przeciwlękowych, przeciwpsychotycznych lub stabilizujących nastrój
3. Aktualne korzystanie z psychoterapii
4. Zaburzenia neurologiczne w wywiadzie
5. Uzależnienie od substancji psychoaktywnych lub nałogowy hazard
6. Przeciwwskazania medyczne do zastosowania paroksetyny lub chlorowodorku naltreksonu (zgodnie z Charakterystyką Produktu Leczniczego)
Oraz (ze względu na planowane badanie w rezonansie magnetycznym:
7. Obecność w ciele metalowych przedmiotów lub urządzeń elektrycznych (rozrusznik serca, pompa insulinowa, metalowe klipsy, itp.)
8. Klaustrofobia
9. Rozległe tatuaże w okolicach twarzy

E.5 End points

E.5.1

Primary end point(s)

Scores (change) in questionnaires: Sex Addiction Screening Test (SAST), Sexual Arousability Inventory (SAI), Multidimensional Sexuality Questionnaire (MSQ), Impulsivity Questionnaire (IVE)

Wyniki punktowe (zmiana) uzyskiwane w kwestionariuszach Sex Addiction Screening Test (SAST), Sexual Arousability Inventory (SAI), Multidimensional Sexuality Questionnaire (MSQ), i Kwestionariusz impulsywności (IVE)

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline, after 8 and 20 weeks of treatment, 20 weeks after completion of the medication

Początek badania, po 8 i 20 tygodniach leczenia, następnie po 20 tygodniach od przerwania leczenia

E.5.2

Secondary end point(s)

Changes within amygdala and ventral striatum activity in response to visual stimulation using standardized visual sexual cues

zmiany aktywności w obrębie ciał migdałowatych i brzusznego prążkowia w odpowiedzi na stymulację wizualną za pomocą wystandaryzowanych wzrokowych bodźców seksualnych

E.5.2.1

Timepoint(s) of evaluation of this end point

Baseline, after 20 weeks of medication, 20 weeks after completion of the medication

Początek badania, po 20 tygodniach leczenia, następnie po 20 tygodniach od przerwania leczenia

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

Yes

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

Yes

E.8.2.3

Other

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)

F.2 Gender

F.2.1

Female

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

Brak

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

2017-04-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-08-18

P. End of Trial
P.	End of Trial Status	Ongoing

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