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

Newron Pharmaceuticals SPA125 sites in 4 countries679 target enrollmentNovember 2007

ConditionsIdiopathic Parkinson's Disease

InterventionsSafinamide (as add-on therapy)

DrugsSafinamide (as add-on therapy)

Overview

Phase: Phase 3
Intervention: Safinamide (as add-on therapy)
Conditions: Idiopathic Parkinson's Disease
Sponsor: Newron Pharmaceuticals SPA
Enrollment: 679
Locations: 125
Primary Endpoint: Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

March 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Newron Pharmaceuticals SPA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•30 to 80 years, inclusive, at screening.
•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.
•Receiving treatment with a single dopamine agonist at a stable dose for at least 4 weeks prior to the screening visit.
•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:
•Any indication of forms of Parkinsonism, other than idiopathic Parkinson's Disease.
•If female, be pregnant or lactating.
•Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
•Currently experiencing end of dose wearing off or on-off phenomena, disabling peak dose or biphasic dyskinesias, or unpredictable or widely swinging fluctuations.
•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.
•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.
•Have received treatment with safinamide previously.
•Concomitant disease likely to interfere with the study medication (e.g. capable of altering absorption, metabolism or elimination of the study drug).
•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.

Arms & Interventions

1

50 mg/day Safinamide

Intervention: Safinamide (as add-on therapy)

2

Safinamide 100mg/day

Intervention: Safinamide (as add-on therapy)

3

Placebo 0mg/Safinamide

Intervention: Safinamide (as add-on therapy)

Outcomes

Primary Outcomes

Evaluate the changes from baseline to W24 in motor symptoms (UPDRS Section III).

Time Frame: 24 weeks

Secondary Outcomes

Evaluate the changes from baseline to W24 in activities of daily living, cognition, change in global clinical status, responder rates with regard to motor symptoms and health related quality of life(24 weeks)