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

NCT ID: NCT00865579

Last Updated: 2017-09-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 964 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2012-06-30

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

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Safinamide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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 Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Willmer, MD

Role: STUDY_DIRECTOR

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

Locations

Research Site

Timuș, , Romania

Countries

Romania

Other Identifiers

63,901

Identifier Type: -

Identifier Source: secondary_id

EudraCT-Number: 2008-005492-94

Identifier Type: -

Identifier Source: secondary_id

28850

Identifier Type: -

Identifier Source: org_study_id