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)

A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 80 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Safinamide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 227 participants
Where: No sites listed yet
Study dates: Jun 2005to Jul 2007
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
The patient was compliant with taking study medication in Study 015.
The patient is willing to participate in the study and signed an approved Informed Consent form.

Who cannot join

The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
The patient has shown clinically significant deterioration during participation in Study 015.
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.

About this study

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.

Read the 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).

Conditions: Parkinson's Disease
Being tested: Safinamide, Placebo
Keywords: Parkinson's disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SafinamideDrug
SafinamideDrug
PlaceboDrug

Study groups in NCT00642889
Study group	Role	What they receive
High Dose	Experimental	150-200mg/day Receives: Drug: Safinamide
Low dose	Experimental	50-100mg/day Receives: Drug: Safinamide
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2005Jul 2007

First posted25 Mar 2008 (estimated)
Study startJun 2005
Primary completionJan 2007
Study completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642889
Sponsor's protocol ID: NW-1015/017/III/2003
Status last verified: Mar 2008
First submitted: 21 Mar 2008
Last updated: 25 Mar 2008
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Adaptive DBS to Offset STN Dysregulation During Exercise in PD
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Compulsive Eating and Brain's Reward System in Different Pathologies
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Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00642889
Acronym / sponsor ID: NW-1015/017/III/2003
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Jan 2007 (actual)
Study completion: Jul 2007 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
High Dose	Experimental	Drug: Safinamide150-200mg/day
Low dose	Experimental	Drug: Safinamide50-100mg/day
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 30 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.
The patient was compliant with taking study medication in Study 015.
The patient is willing to participate in the study and signed an approved Informed Consent form.

Key exclusion criteria (3 listed)

The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
The patient has shown clinically significant deterioration during participation in Study 015.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Safinamide	Drug	High Dose
Safinamide	Drug	Low dose
Placebo	Drug	Placebo

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2008.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00642889.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2008.