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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00865579
• Other study ID #: 28850
• Secondary ID: 63,901EudraCT-Nu
• Status: Terminated
• Phase: Phase 3
• First received: March 10, 2009
• Last updated: September 15, 2017
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: September 2017
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 964
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

Locations

Country	Name	City	State
Romania	Research Site	Timis

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Physical Exams		Anticipated time frame up to 3 years
Primary	Change from baseline in Neurologic Exams		Anticipated time frame up to 3 years
Primary	Change from baseline in Vital Signs		Anticipated time frame up to 3 years
Primary	Change from baseline in Laboratory Evaluations		Anticipated time frame up to 3 years
Primary	Change from baseline in Electrocardiograms		Anticipated time frame up to 3 years
Primary	Summary of Participants who had Adverse Experiences		Anticipated time frame up to 3 years
Primary	Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)		Anticipated time frame up to 3 years
Primary	Change from baseline in Dermatologic Exams		Anticipated time frame up to 3 years
Primary	Change from baseline in Ophthalmologic Exams		Anticipated time frame up to 3 years
Secondary	Change from baseline in Health Resource Utilisation		Anticipated time frame up to 3 years
Secondary	Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale		Anticipated time frame up to 3 years
Secondary	Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)		Anticipated time frame up to 3 years