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Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)

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ClinicalTrials.gov Identifier: NCT00642889
Recruitment Status : Completed
First Posted : March 25, 2008
Last Update Posted : March 25, 2008
Sponsor:
Information provided by:
Newron Pharmaceuticals SPA

Brief Summary:
To determine the long-term safety and efficacy of a dose range of safinamide of 50-200 mg/day, p.o., compared to placebo, as add-on therapy in patients with early idiopathic Parkinson's disease who are currently receiving a stable dose of a single dopamine (DA) agonist.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: Safinamide Drug: Placebo Phase 3

Detailed Description:
The study will consist of 12 months of double-blind treatment. Patients will continue to take the original treatment administered in Study 015 (safinamide 100 mg/day, safinamide 200 mg/day, or placebo).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.
Study Start Date : June 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: High Dose
150-200mg/day
Drug: Safinamide
Experimental: Low dose
50-100mg/day
Drug: Safinamide
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. Time from baseline to intervention (e.g., increase in dose of DA-agonist; addition of another DA-agonist, levodopa, or other PD therapy; or discontinuation due to lack of efficacy); or time from baseline to the last follow up, if the event did not occur


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
  2. The patient was compliant with taking study medication in Study 015.
  3. The patient is willing to participate in the study and signed an approved Informed Consent form.

Exclusion Criteria:

  1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
  2. The patient has shown clinically significant deterioration during participation in Study 015.
  3. The patient discontinued Study 015 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) in Study 015.

Responsible Party: Dr Stefano Rossetti, Newron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00642889     History of Changes
Other Study ID Numbers: NW-1015/017/III/2003
First Posted: March 25, 2008    Key Record Dates
Last Update Posted: March 25, 2008
Last Verified: March 2008

Keywords provided by Newron Pharmaceuticals SPA:
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
Dopamine
Dopamine Agonists
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents