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

NCT00865579 | Terminated Phase 3

• 3 other identifiers: 2885063,901EudraCT-Number: 2008-005492-94
• Study Type: interventional
• Target: 964
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Change from baseline in Physical Exams

  Anticipated time frame up to 3 years

• Change from baseline in Neurologic Exams

  Anticipated time frame up to 3 years

• Change from baseline in Vital Signs

  Anticipated time frame up to 3 years

• Change from baseline in Laboratory Evaluations

  Anticipated time frame up to 3 years

• Change from baseline in Electrocardiograms

  Anticipated time frame up to 3 years

• Summary of Participants who had Adverse Experiences

  Anticipated time frame up to 3 years

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

  Anticipated time frame up to 3 years

• Change from baseline in Dermatologic Exams

  Anticipated time frame up to 3 years

• Change from baseline in Ophthalmologic Exams

  Anticipated time frame up to 3 years

Secondary Outcomes (3)

• Change from baseline in Health Resource Utilisation

  Anticipated time frame up to 3 years

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

  Anticipated time frame up to 3 years

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

  Anticipated time frame up to 3 years

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Safinamide 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.

1

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Study Sites (1)

Research Site

Timuș, Romania

Location

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

safinamide

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jonathan Willmer, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 19, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: September 18, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)