## Protocol Section
### Identification Module
**NCT ID:** NCT00865579

**Brief Title:** Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

**Official Title:** Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

#### Organization Study ID Info
**ID:** 28850
#### Organization
**Class:** INDUSTRY
**Full Name:** Newron Pharmaceuticals SPA
#### Secondary ID Infos
**ID:** 63,901
**ID:** EudraCT-Number: 2008-005492-94
### Status Module
#### Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-09-18

**Type:** ACTUAL

**Last Update Submit Date:** 2017-09-15

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2012-06

**Type:** ACTUAL

#### Start Date
**Date:** 2009-04

**Type:** ACTUAL

**Status Verified Date:** 2017-09

#### Study First Post Date
**Date:** 2009-03-19
**Type:** ESTIMATED
**Study First Submit Date:** 2009-03-10
**Study First Submit QC Date:** 2009-03-18
**Why Stopped:** study terminated early due to change in Sponsorship
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Newron Pharmaceuticals SPA

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO-B, the major DA metabolising enzyme in humans.

Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.

### Conditions Module

**Conditions:**

- Parkinson's Disease

**Keywords:**

- MAO inhibitors

- motor fluctuations

- dyskinesia

- Parkinson's Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 964

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All subjects to receive first 50mg/d Safinamide with an increase of target dose of 100mg/d after 14 days of taper period until end of treatment visit. In case of any intolerance the daily dose of 100mg might be decreased to 50mg/d. Patients permanently discontinuing treatment will enter a 7day taper phase before treatment discontinuation at a dose of 50mg/day. Subjects already taking 50mg/d may stop Safinamide immediately.

**Intervention Names:**

- Drug: Safinamide

**Label:** 1

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm).

Trial Medication is to be taken once daily, in the morning.

**Name:** Safinamide

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline in Physical Exams

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Neurologic Exams

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Vital Signs

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Laboratory Evaluations

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Electrocardiograms

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Summary of Participants who had Adverse Experiences

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Dermatologic Exams

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Ophthalmologic Exams

**Time Frame:** Anticipated time frame up to 3 years

#### Secondary Outcomes

**Measure:** Change from baseline in Health Resource Utilisation

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale

**Time Frame:** Anticipated time frame up to 3 years

**Measure:** Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)

**Time Frame:** Anticipated time frame up to 3 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. the subject has completed a previous clinical study with Safinamide in PD
2. the subject successfully completed all trial requirements of the antecedent trial
3. if female, they must be either post-menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential, they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive
4. subjects must be willing and able to participate in the trial and provide written informed consent

Exclusion Criteria:

1. the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide
2. if female, the subject is pregnant or lactating
3. any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Timis

**Country:** Romania

**Facility:** Research Site

#### Overall Officials

**Official 1:**

**Affiliation:** EMD Serono Inc., an Affiliate of Merck KGaA, Darmstadt, Germany

**Name:** Jonathan Willmer, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** No efficacy endpoints were analyzed in this trial.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11960

- Name: Monoamine Oxidase Inhibitors

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
