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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

Primary Purpose

Idiopathic Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Safinamide

Placebo

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Low dose (50-100mg/day)

High dose (150-200 mg/day)

Outcomes

Primary Outcome Measures

UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00643045

First Posted

March 21, 2008

Last Updated

March 24, 2008

Sponsor

Newron Pharmaceuticals SPA

1. Study Identification

Unique Protocol Identification Number

NCT00643045

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

December 2004 (undefined)

Primary Completion Date

January 2006 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Newron Pharmaceuticals SPA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Parkinson's Disease

Keywords

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

269 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Low dose (50-100mg/day)

Arm Title

Arm Type

Experimental

Arm Description

High dose (150-200 mg/day)

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Safinamide

Intervention Type

Drug

Intervention Name(s)

Safinamide

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

UPDRS Section III (Motor Examination [ME]) total score at Baseline, each post-baseline visit and Endpoint (Visit 8 [Week 24]).

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: