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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newron Sweden AB
ClinicalTrials.gov Identifier:
NCT00865579
First received: March 10, 2009
Last updated: March 28, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: Safinamide
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients

Resource links provided by NLM:


Further study details as provided by Newron Sweden AB:

Primary Outcome Measures:
  • Change from baseline in Physical Exams [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Neurologic Exams [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Vital Signs [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Laboratory Evaluations [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Electrocardiograms [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Summary of Participants who had Adverse Experiences [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Dermatologic Exams [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Ophthalmologic Exams [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in Health Resource Utilisation [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]
  • Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39) [ Time Frame: Anticipated time frame up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 965
Study Start Date: March 2009
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865579

Locations
Romania
Research Site
Timis, Romania
Sponsors and Collaborators
Newron Sweden AB
Investigators
Study Director: Jonathan Willmer, MD EMD Serono Inc., an Affiliate of Merck KGaA, Darmstadt, Germany
  More Information

No publications provided

Responsible Party: Newron Sweden AB
ClinicalTrials.gov Identifier: NCT00865579     History of Changes
Other Study ID Numbers: 28850, 63,901, EudraCT-Number: 2008-005492-94
Study First Received: March 10, 2009
Last Updated: March 28, 2013
Health Authority: Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care ; Belgium: Federal Agency for Medicinal Products and Health Products ;
Canada: Health Canada
Switzerland: Ethikkommission
Chile: Instituto de Salud Pública de Chile
Czech Republic: Ethics Committee
Germany: Ethics Commission
Finland: Ethics Committee
Spain: Ministry of Health and Consumption
Slovak Republic: Ethics Committee
Estonia: The State Agency of Medicine
Denmark: The Ministry of the Interior and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: Institutional Ethics Committee
India: Central Drugs Standard Control Organization
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Ministry of Health
Romania: National Medicines Agency
Slovakia: State Institute for Drug Control
Thailand: Ministry of Public Health
Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Newron Sweden AB:
MAO inhibitors
motor fluctuations
dyskinesia
Parkinson's Disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 30, 2014