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

Primary Purpose

Parkinson's Disease

Status

Terminated

Phase

Phase 3

Locations

Romania

Study Type

Interventional

Intervention

Safinamide

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring MAO inhibitors, motor fluctuations, dyskinesia, Parkinson's Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

the subject has completed a previous clinical study with Safinamide in PD
the subject successfully completed all trial requirements of the antecedent trial
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
subjects must be willing and able to participate in the trial and provide written informed consent

Exclusion Criteria:

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
if female, the subject is pregnant or lactating
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

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 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.

Outcomes

Primary Outcome Measures

Change from baseline in Physical Exams

Change from baseline in Neurologic Exams

Change from baseline in Vital Signs

Change from baseline in Laboratory Evaluations

Change from baseline in Electrocardiograms

Summary of Participants who had Adverse Experiences

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

Change from baseline in Dermatologic Exams

Change from baseline in Ophthalmologic Exams

Secondary Outcome Measures

Change from baseline in Health Resource Utilisation

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

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

Full Information

NCT ID

NCT00865579

First Posted

March 10, 2009

Last Updated

September 15, 2017

Sponsor

Newron Pharmaceuticals SPA

1. Study Identification

Unique Protocol Identification Number

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Why Stopped

study terminated early due to change in Sponsorship

Study Start Date

April 2009 (Actual)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Newron Pharmaceuticals SPA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

MAO inhibitors, motor fluctuations, dyskinesia, Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

964 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Safinamide

Intervention 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.

Primary Outcome Measure Information:

Title

Change from baseline in Physical Exams

Time Frame