Clinical Trials Register

Summary
EudraCT Number:	2018-004892-11
Sponsor's Protocol Code Number:	SteP-on
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2020-10-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-004892-11

A.3

Full title of the trial

A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients

Studio multicentrico randomizzato, in doppio cieco, controllato con placebo di valutazione dell’effetto della safinamide sul freezing della marcia nei pazienti con malattia di parkinson in fase medio-avanzata

A.3.1

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

A randomized, double-blind, placebo controlled, multicentre study to evaluate the effect of safinamide on freezing of gait (FOG) in mid- to late-stage fluctuating PD patients

A.3.2

Name or abbreviated title of the trial where available

SteP-on

A.4.1

Sponsor's protocol code number

SteP-on

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	OSPEDALE SANTA MARIA DELLA MISERICORDIA
B.1.3.4	Country	Italy
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	Zambon s.p.a.
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	Azienda Ospedaliera di Perugia
B.5.2	Functional name of contact point	S.C. Clinica Neurologica
B.5.3	Address:
B.5.3.1	Street Address	Piazzale Menghini 1
B.5.3.2	Town/ city	Perugia
B.5.3.3	Post code	06132
B.5.3.4	Country	Italy
B.5.4	Telephone number	0755783830
B.5.5	Fax number	0755784229
B.5.6	E-mail	clinica.neurologica@unipg.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	XADAGO - 100 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ZAMBON 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.3.1	Product name	Xadago
D.3.2	Product code	[043906039]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SAFINAMIDE METANSOLFONATO
D.3.9.1	CAS number	202825-46-5
D.3.9.2	Current sponsor code	MSC2191632B
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	XADAGO - 50 MG- COMPRESSA RIVESTITA CON FILM- USO ORALE- BLISTER (PVC/PVDC/ALLUMINIO)- 30 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	ZAMBON 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.3.1	Product name	Xadago
D.3.2	Product code	[043906039]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SAFINAMIDE METANSOLFONATO
D.3.9.1	CAS number	202825-46-5
D.3.9.2	Current sponsor code	MSC2191632B
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	Tablet
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

• Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD
• A Modified Hoehn and Yahr stage of = 4 in the “off” state;
• A stable (4 weeks since last modification) anti-parkinsonian therapy;
• The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs “frozen” or “glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0)

• Soggetti maggiorenni con Malattia di Parkinson idiopatica;
• Stadio Hoehn e Yahr di = 4 nello stato "off";
• Una terapia antiparkinsoniana stabile (4 settimane dopo l'ultima modifica)
• La presenza di FOG (definita come la persistenza di esitazione dell'andatura e fallimento nell'avvio dell'andatura o la sensazione riportata di avere le gambe "congelate" o "incollate a terra") anche su un trattamento dopaminergico ottimizzato (pazienti con punteggio all’item 3 del FOG-Q > 0)

E.1.1.1

Medical condition in easily understood language

idiopathic Parkinson's disease (H & Y: = 4 in "off"); in stable therapy with hesitation of gait and failure to start gait or the feeling of having legs "glue to the ground"

M. di Parkinson idiopatica (H&Y: = 4 in "off"); in terapia stabile con esitazione dell'andatura e fallimento nell'avvio dell'andatura o la sensazione riportata di avere le gambe "incollate a terra"

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10013113
E.1.2	Term	Disease Parkinson's
E.1.2	System Organ Class	100000004852

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 effectiveness of safinamide, added to standard treatment, on FOG in fluctuating PD patients

Valutare l'efficacia della safinamide, aggiunta al trattamento standard, sul FOG in pazienti con MP in fase medio-avanzata

E.2.2

Secondary objectives of the trial

To verify the impact of safinamide on Quality of life (QoL) and Motor scores in fluctuating PD patients

Verificare l'impatto della safinamide sulla qualità della vita (QoL) e sui punteggi motori in pazienti con PD fluttuante

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects of both genders over 18 years of age, with a clinical diagnosis of idiopathic PD according to UK Brain Bank diagnostic criteria;
• A Modified Hoehn and Yahr stage of = 4 in the “off” state;
• A stable (4 weeks since last modification) anti-parkinsonian therapy, always including levodopa (L- dopa)/dopa-decarboxylase inhibitor (DDI);
• 1 month wash out is needed if patient received other MAO-B inhibitors;
• The presence of FOG (defined as the persistence of gait hesitation and failure in starting the gait or the reported sensation of having the legs “frozen” or “glued to the ground”) even on an optimized dopaminergic treatment (patients with FOG item 3 score >0)

• Soggetti di entrambi i sessi oltre i 18 anni di età, con una diagnosi clinica di MPidiopatica secondo i criteri diagnostici della UK Brain Bank;
• Stadio Hoehn e Yahr di = 4 nello stato "off";
• Una terapia antiparkinsoniana stabile (4 settimane dopo l'ultima modifica), che include sempre levodopa (L-dopa) / inibitore della dopa-decarbossilasi (DDI);
• È necessario 1 mese di washout nei pazienti che hanno ricevuto trattamento con altri inibitori MAO-B;
• La presenza di FOG (definita come la persistenza di esitazione dell'andatura e fallimento nell'avvio dell'andatura o la sensazione riportata di avere le gambe "congelate" o "incollate a terra") anche su un trattamento dopaminergico ottimizzato (pazienti con punteggio all’item 3 del FOG-Q > 0)

E.4

Principal exclusion criteria

Subjects with other severe neurological or systemic concomitant conditions, sensory deficits, clear signs of peripheral neuropathy or orthopaedic comorbidities which may interfere with gait;
• Patients for whom Safinamide is contraindicated according to the current SmPC.
Female subjects with ongoing or lactating or fertile pregnancy who do not adopt or intend to use adequate methods of contraception for the duration of the study. Individuals who agree to use a reliable contraceptive method during the study will be admitted (for example: more prophylactic oral contraceptive, intrauterine device (DIU or IUD) more prophylactic, diaphragm with more prophylactic spermicide). Subjects with sterile partners (eg vasectomy) and menopausal subjects for at least 1 year or surgically sterile may be included in the study.

• Soggetti con altre gravi condizioni neurologiche o sistemiche concomitanti, deficit sensoriali, chiari segni di neuropatia periferica o comorbidità ortopediche che possono interferire con la deambulazione;
• Pazienti per i quali la safinamide è controindicata secondo l'attuale SmPC.
• Soggetti di sesso femminile con gravidanza in corso, in allattamento o in età fertile che non adottano o non intendono utilizzare adeguati metodi di contraccezione per tutta la durata dello studio. Saranno ammessi i soggetti che accettano di far uso di un metodo contraccettivo affidabile durante lo studio (ad esempio: contraccettivo orale più profilattico, dispositivo intrauterino (DIU o IUD) più profilattico, diaframma con spermicida più profilattico). I soggetti con partner sterili (per esempio vasectomia) e i soggetti in menopausa da almeno 1 anno o chirurgicamente sterili potranno essere inclusi nello studio.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in the FOG-scale (= 3 points)

Cambiamento rispetto al basale nella scala FOG (= 3 punti)

E.5.1.1

Timepoint(s) of evaluation of this end point

14 weeks

14 settimane

E.5.2

Secondary end point(s)

Change from baseline in UPDRS, FES-I, TUG and PDQ-39

Cambiamento nelle scale UPDRS, FES-I, TUG e PDQ-39

E.5.2.1

Timepoint(s) of evaluation of this end point

14 weeks

14 settimane

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

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

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

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

Information not present in EudraCT

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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

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

128

F.4.2

For a multinational trial

F.4.2.1

In the EEA

128

F.4.2.2

In the whole clinical trial

128

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)

Subjects will be entered in the follow-up of usual care

I soggetti verranno assistiti continuativamente come nella normale pratica clinica

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

2021-04-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-12-17

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

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