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

March 24, 2008 updated by: Newron Pharmaceuticals SPA

A Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200 mg/day and Low Dose: 50 to 100 mg/day) orally, as 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 agonist. It is hypothesized that, over a 24-week period, add-on treatment with safinamide will result in greater improvement of motor symptoms in these patients, compared to treatment with a dopamine agonist alone.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with a diagnosis of idiopathic Parkinson's disease of less than 5 years duration, and a Hoehn and Yahr Stage of I to III,
  • who were receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to Visit 1 (Screening).

Exclusion Criteria:

  • Patients with medical conditions and/or taking concomitant medications that would have put them at risk, interfered with the study evaluations, or made them unable to complete the requirements of the study;
  • patients with a diagnosis or recent history of substance abuse,
  • a history of psychosis,
  • who were depressed,
  • had evidence of dementia or cognitive dysfunction,
  • or who were experiencing end of dose wearing-off;
  • female patients of childbearing potential;
  • patients who have previously received safinamide.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 3
Drug: Placebo
Experimental: 1
Low dose (50-100mg/day)
Drug: Safinamide
Experimental: 2
High dose (150-200 mg/day)
Drug: Safinamide

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
UPDRS Section III (ME) item (& total) scores.CGI Change from Baseline score.UPDRS Section II (ADL) item (& total) scores.CGI Severity of Illness score. H&Y Staging.All above at each visit and Endpoint (LOCF). Cogtest PD battery score each visit
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Newron Pharmaceuticals SPA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcelo Merello, MD, Instituto FLENI, Buenos Aires
  • Principal Investigator: Rolando Giannaula, MD, Hospital Español - Servicio de Neurologia, Buenos Aires
  • Principal Investigator: Federico Micheli, MD, Hospital de Clinicas, Servicio de Movimientos, Buenos Aires
  • Principal Investigator: Marcelo Miranda, MD, Liga Chilena Contra el Mal De Parkinson, Santiago, Chile
  • Principal Investigator: David Saez, MD, Hospital Barros Luco Trudeau, Servicio de Neurologia, Santiago, Chile
  • Principal Investigator: Roque Villagra, MD, Hospital Salvador-Neurologia, Santiago, Chile
  • Principal Investigator: Yuri Takeuchi, MD, Fundaciόn Valle de Lili Direcciόn Médica, Cali-Valle, Colombia
  • Principal Investigator: Mauricio Acevedo, MD, Hospital Militar, Departamento de Neurología, Bogotà-D.C, Colombia
  • Principal Investigator: Pablo Lorenzana, MD, Consultorio, Bogotà-D.C, Colombia
  • Principal Investigator: Madhuri Behari, MD, Department of Neurology, All India Institute of Medical Science (AIIMS), New Delhi, India
  • Principal Investigator: Mohit Bhatt, MD, Movement Disorder Clinic, Jaslok Hospital, Mumbai, India
  • Principal Investigator: Rupam Borgohain, MD, Nizam's Institute of Medical Sciences (NIMS), Hyderabad, India
  • Principal Investigator: Arunkumar Shah, MD, B.Y.L. Nair Hospital & T.N. Medical College, Mumbai, India
  • Principal Investigator: Ajit Roy, MD, St John's Medical College & Hospital, Bangalore, India
  • Principal Investigator: Uday Babu Rao Muthane, MD, National Institute of Mental Health and Neuro sciences, Bangalore, India
  • Principal Investigator: Fabrizio Stocchi, MD, IRCCS Neuromed Via Atinense 18 Pozzilli (IS), Italy
  • Principal Investigator: Leonardo Scarzelia, MD, Ospedale Evangelico Valdese, Torino, Italy
  • Principal Investigator: Gianpietro Nodera, MD, Dipartimento di Neurologia Casa di Cura "Villa Margherita", Vicenza, Italy
  • Principal Investigator: Pezzoli, MD, Isituti Clinici di Perfezionamento Centro Parkison, Milano, Italy
  • Principal Investigator: Leontino Battistin, MD, Dipartimento di Neuroscienze, Padova, Italy
  • Principal Investigator: Marco Onofri, MD, Divisione di Neurologia, Ospedale civile di Pescara, Italy
  • Principal Investigator: Paolo Lamberti, MD, Clinica Neurologica I Policinico di Bari, Italy
  • Principal Investigator: Alessandra Monge, MD, Osp. S. Giovanni Battista, Roma, Italy
  • Principal Investigator: Paolo Barone, Prof, MD, Dipartimento di Scienze Neurologiche, Universita di Napoli Federico II, Naples, Italy
  • Principal Investigator: Giovanni Abruzzese, MD, Dipartimento di Neuroscienze DINOG, Universita degli Studi di Genova, Italy
  • Principal Investigator: Roberto Marconi, MD, Ospedale della Misericordia, Grosseto, Italy
  • Principal Investigator: Kulisevsky, MD, Serv. Neurologia, Barcelona, Spain
  • Principal Investigator: Lopez Lozano, MD, H. Puerta de Hierro, Serv. Neurologia, Madrid, Spain
  • Principal Investigator: Antonio Vacquez, MD, H. Clinico San Carlos, Ser. Neurologia, Spain
  • Principal Investigator: Schapira, Prof, MD, Department of Neurology, Royal Free Hospital, UK
  • Principal Investigator: Chaudhuri, MD, Day Hospital, Care of the Elderly, Lewisham University Hospital, London, UK
  • Principal Investigator: Barker, MD, Cambridge Centre for Brain Repair, Cambridge, UK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NW 1015/015/III/2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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