Clinical trial NCT00865579: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: MAO inhibitors
motor fluctuations
dyskinesia
Parkinson's Disease
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 964
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from baseline in Physical Exams
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Neurologic Exams
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Vital Signs
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Laboratory Evaluations
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Electrocardiograms
timeFrame: Anticipated time frame up to 3 years
measure: Summary of Participants who had Adverse Experiences
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Dermatologic Exams
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Ophthalmologic Exams
timeFrame: Anticipated time frame up to 3 years
Secondary outcomes:
measure: Change from baseline in Health Resource Utilisation
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale
timeFrame: Anticipated time frame up to 3 years
measure: Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)
timeFrame: Anticipated time frame up to 3 years
Other outcomes:
Locations:
city: Timis
country: Romania
facility: Research Site
Study officials:
affiliation: EMD Serono Inc., an Affiliate of Merck KGaA, Darmstadt, Germany
name: Jonathan Willmer, MD
role: STUDY_DIRECTOR
References: