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COMPLETEDPHASE3

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

A Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist

NCT00605683•Newron Pharmaceuticals SPA

View on ClinicalTrials.gov

Summary

Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic 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 man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosis of idiopathic Parkinson's Disease of less than 5 years duration, with a Hoehn and Yahr stage of I-III. The diagnosis should be based on medical history and neurological examination.
•2. 30 to 80 years, inclusive, at screening.
•3. If female, be either post menopausal for at least 2 years, surgically sterilised 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 purposes of this study, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive.
•4. Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.
•5. Willing and able to participate in the study and have provided written, informed consent.

Exclusion Criteria

•To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
•1. Any indication of forms of Parkinsonism, other than idiopathic Parkinson's Disease.
•2. If female, be pregnant or lactating.
•3. Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
•4. Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
•5. Current clinically significant gastrointestinal, renal, hepatic, endocrine, pulmonary or cardiovascular disease, including acute gastric ulcer, hypertension that is not well controlled, asthma, chronic obstructive pulmonary disease (COPD), and Type I diabetes. Subjects with a history of gastric ulcer who have not had a recent episode of acute gastritis and are not currently experiencing gastric pain will be eligible for inclusion.
•6. Second- or third-degree atrioventricular block or sick sinus syndrome, uncontrolled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction within 3 months of the screening visit, or significant ECG abnormality, including QTc ≥ 450 msec (males) or ≥ 470 msec (females), where QTc is based on Bazett's correction method.
•7. Have received treatment with safinamide previously.
•8. Concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
•9. History of, or current psychosis (e.g. schizophrenia or psychotic depression) or a score ≥ 3 on item 2 (thought disorder) or 3 (depression) of the UPDRS, Section I at screening.
+17 more criteria

Locations (125)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Neurological Institute

Phoenix, Arizona, United States

Pacific Neuroscience Medical Group

Oxnard, California, United States

San Francisco Clinical Research Center

San Francisco, California, United States

Parkinson's Institute

Sunnyvale, California, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Parkinson's Disease and Movement Disorder Center

Boca Raton, Florida, United States

Neurologic Consultants P.A.

Fort Lauderdale, Florida, United States

University Of Florida

Gainesville, Florida, United States

Parkinson's Disease Treatment Center of SW Florida

Port Charlotte, Florida, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

January 1, 2012

Completion Date

March 1, 2012

Last Updated

October 29, 2013

Enrollment

679

ACTUAL participants

Conditions

Idiopathic Parkinson's Disease

Interventions

Safinamide (as add-on therapy)

DRUG

Safinamide (as add-on therapy)

DRUG

Safinamide (as add-on therapy)

DRUG

Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease

NCT05094011

Idiopathic Parkinson's Disease

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COMPLETEDPHASE3

Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

NCT02610231

Idiopathic Parkinson's Disease

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COMPLETEDNA

Robot Walking Rehabilitation in Parkinson's Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist

Inclusion Criteria

Exclusion Criteria

Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease

Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's Disease

Robot Walking Rehabilitation in Parkinson's Disease

Dopamine Effect on Inhibitory Control

PA Behavior and HRQoL in Parkinson's Disease Patients Patients: Role of Social Cognitive Variables

Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease