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

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.

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Drug: Safinamide

• Study Type: Interventional
• Enrollment (Actual): 964
• Phase: Phase 3

Contacts and Locations

Study Locations

• Romania
  • Timis, Romania
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; 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.

Drug: Safinamide; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Physical Exams	Anticipated time frame up to 3 years
Change from baseline in Neurologic Exams	Anticipated time frame up to 3 years
Change from baseline in Vital Signs	Anticipated time frame up to 3 years
Change from baseline in Laboratory Evaluations	Anticipated time frame up to 3 years
Change from baseline in Electrocardiograms	Anticipated time frame up to 3 years
Summary of Participants who had Adverse Experiences	Anticipated time frame up to 3 years
Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)	Anticipated time frame up to 3 years
Change from baseline in Dermatologic Exams	Anticipated time frame up to 3 years
Change from baseline in Ophthalmologic Exams	Anticipated time frame up to 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Health Resource Utilisation	Anticipated time frame up to 3 years
Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale	Anticipated time frame up to 3 years
Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)	Anticipated time frame up to 3 years

Collaborators and Investigators

• Sponsor: Newron Pharmaceuticals SPA
• Investigators: Study Director: Jonathan Willmer, MD, EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 10, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Parkinson's Disease; dyskinesia; MAO inhibitors; motor fluctuations
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 28850; 63,901; EudraCT-Number: 2008-005492-94

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No efficacy endpoints were analyzed in this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No