Parkinson's DiseasePhase 3NCT01286935
18-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PD
A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA.
Trial summary
The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa. 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
- 544 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Aug 2010
- 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 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
- The patient was compliant with taking study medication in Study 016.
- 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 016, and has reached Hoehn and Yahr Stage V.
- The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
About this study
Official title: A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
- Conditions
- Parkinson's Disease
- Being tested
- Safinamide, Placebo
- Keywords
- Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,
- 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 group | Role | What they receive |
|---|---|---|
| Low Dose (50mg/day) | Experimental | Not described Receives: Drug: Safinamide |
| High Dose (100mg/day) | Experimental | Not described 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.
Mean change in the dyskinesias rating scale (DRS) during "on" time
mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
Measured: Up to 104 weeks (from baseline 016 to EOS study 018)
Secondary outcomes (1)
Endpoints include 'ON time', responder rates and UPDRS IV change
- Chge in ON time (ON+ON minor dysk),
- Diary Resp Rate at 12-m, 18 \& 24 m on the ITT\&mITT pop\&pts who completed 2-yr period
- UPDRS IV chge in total score,items 32-35 \& 32-34
- Time develop tblsome dysk(> 30min incr of tblsome dysk)
- Time develop any (minor \&/or tblsome) dysk (> 30 min incr of dysk)
- Chge ADLs during ON, vs pbo(UPDRS II)
- Maintenance of effect in UPDRS II "resp'(resp >=20% impr in ADLs).
- chge in L-dopa dose
- chge in any PD(other than L-dopa)drug dose
- Chge in UPDRS III, CGI-C and CGI-S
- Chge in diary categories(ON, OFF, ON minor dysk, ON tblsome dysk, ASLEEP)
Measured: Up to 104 weeks (from baseline 016 to EOS study 018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startAug 2007
- Primary completionApr 2010
- Study completionAug 2010
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
- 544 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- See Study 016 for details, Principal investigator, PI's are the same as for study NW-1015/016/III/2006
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286935
- Sponsor's protocol ID
- NW-1015/018/III/2006
- Other IDs
- 2006-005861-21
- Status last verified
- Jan 2011
- First submitted
- 23 Aug 2010
- Last updated
- 31 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or Anticholinergic
- ClinicalTrials.gov ID
- NCT01286935
- Acronym / sponsor ID
- NW-1015/018/III/2006
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, PD, Levodopa, Patients with idiopathic Parkinson's Disease with motor fluctuations,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 544 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Jan 2011 (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.
The purpose of this study is to determine the long-term efficacy and safety of two doses of safinamide (50 and 100 mg/day, p.o), compared to placebo, as add-on therapy in patients with idiopathic Parkinson's disease with motor fluctuations, who are currently receiving a stable dose of levodopa.
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 |
|---|---|---|
| Low Dose (50mg/day) | Experimental | Drug: Safinamide |
| High Dose (100mg/day) | Experimental | Drug: Safinamide |
| 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 016, or, if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24, as part of the Retrieved Dropout (RDO) population.
- The patient was compliant with taking study medication in Study 016.
- 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 016, and has reached Hoehn and Yahr Stage V.
- The patient discontinued Study 016 prematurely for any reason, and did not return for scheduled efficacy evaluations at Weeks 12 and 24.
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 | Low Dose (50mg/day) |
| Safinamide | Drug | High Dose (100mg/day) |
| Placebo | Drug | Placebo |
Primary outcome
Mean change in the dyskinesias rating scale (DRS) during "on" time
Time frame: Up to 104 weeks (from baseline 016 to EOS study 018)
mean change in the dyskinesias rating scale (DRS) during "on" time from baseline (study 016) to endpoint (last visit in study 018).
1 secondary outcome
Endpoints include 'ON time', responder rates and UPDRS IV change
Time frame: Up to 104 weeks (from baseline 016 to EOS study 018)
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 31 Jan 2011.
- Related InfoLink provided by the sponsor.
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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.
See Study 016 for details principal investigator
PI's are the same as for study NW-1015/016/III/2006
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 31 Jan 2011. 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?
Mean change in the dyskinesias rating scale (DRS) during "on" time (time frame: Up to 104 weeks (from baseline 016 to EOS study 018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2011.