Idiopathic Parkinson's DiseasePhase 3MOTIONNCT01028586
MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)
A Phase 3 study testing Safinamide, MAO-B inhibitor in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Safinamide, MAO-B inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 507 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2009to May 2012
- 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 subject completed 24 weeks of Trial 27918.
- The subject successfully completed all trial requirements in Trial 27918.
- If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, 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".
- Subject is willing and able to participate in the trial and has provided written, informed consent
Who cannot join
- If female, the subject is pregnant or lactating.
- The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
- The subject has shown clinically significant deterioration during participation in Trial 27918.
- Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
- The investigator deems it is not in the subject's best interest to participate to trial 27938
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
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, extension trial, 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 objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Safinamide, MAO-B inhibitor, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safinamide, MAO-B inhibitorDrug
Safinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
Safinamide, MAO-B inhibitorDrug
Safinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist.
PlaceboDrug
matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: Safinamide, MAO-B inhibitor |
| Arm 2 | Active comparator | Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: Safinamide, MAO-B inhibitor |
| Arm 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
Measured: Week 78
Secondary outcomes (8)
Proportion of subjects requiring intervention
Measured: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
Measured: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
Measured: Week 78
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
Measured: Week 78
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
Measured: Week 78
EuroQoL 5D (EQ-5D) score change from baseline to week 78
Measured: Week 78
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
Measured: Week 78
Cogtest® PD battery test score change from baseline to week 78
Measured: Week 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2012
Why it stopped: Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Willmer, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028586
- Sponsor's protocol ID
- 27938
- Other IDs
- IND: 63,901
- Acronym
- MOTION
- Status last verified
- Aug 2012
- First submitted
- 7 Dec 2009
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
- ClinicalTrials.gov ID
- NCT01028586
- Acronym / sponsor ID
- MOTION / 27938
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals
- Enrolment
- 507 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- First posted
- 9 Dec 2009 (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.
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, extension trial, 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 objective is to evaluate the time to first intervention, as some previous data suggested that safinamide may delay the need for further dopaminergic supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Safinamide, MAO-B inhibitorNumber of Cycles: until progression or unacceptable toxicity develops. |
| Arm 2 | Active comparator | Drug: Safinamide, MAO-B inhibitorNumber of Cycles: until progression or unacceptable toxicity develops. |
| Arm 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject completed 24 weeks of Trial 27918.
- The subject successfully completed all trial requirements in Trial 27918.
- If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception as defined in the protocol for four weeks prior to, during and four weeks after the last dose of trial medication. For the purposes of this trial, 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".
- Subject is willing and able to participate in the trial and has provided written, informed consent
Key exclusion criteria (6 listed)
- If female, the subject is pregnant or lactating.
- The subject experienced a clinically significant adverse effect during trial 27918 that could put the subject at risk according to the investigator's opinion.
- The subject has shown clinically significant deterioration during participation in Trial 27918.
- Motor deterioration during trial 27918 that required upward titration of existing anti-parkinsonian medication or the initiation of an additional anti-parkinsonian medication.
- The investigator deems it is not in the subject's best interest to participate to trial 27938
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, MAO-B inhibitorSafinamide, MAO-B inhibitor 50 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist. | Drug | Arm 1 |
| Safinamide, MAO-B inhibitorSafinamide, MAO-B inhibitor 100 mg: once-daily orally for 78 weeks in addition to their dose of DA-agonist. | Drug | Arm 2 |
| Placebomatching placebo tablets | Drug | Arm 3 |
Primary outcome
Time from baseline to first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy
Time frame: Week 78
8 secondary outcomes
Proportion of subjects requiring intervention
Time frame: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section III (motor) score change from baseline to week 78
Time frame: Week 78
Unified Parkinson's Disease Rating Scale (UPDRS) Section II (ADL) score change from baseline to week 78
Time frame: Week 78
Clinical Global impression (CGI) - Change scale score, change from Day 0 of Trial 27918 to week 78
Time frame: Week 78
Clinical Global impression (CGI) - Severity scale score change from baseline to week 78
Time frame: Week 78
EuroQoL 5D (EQ-5D) score change from baseline to week 78
Time frame: Week 78
Parkinson's Disease Questionnaire (PDQ-39) score change from baseline to week 78
Time frame: Week 78
Cogtest® PD battery test score change from baseline to week 78
Time frame: Week 78
Results and safety
The study was stopped early (reason given: Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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.
Jonathan Willmer, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safinamide, MAO-B inhibitor in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 1 site in Switzerland.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Trial is terminated due to a company decision to return all rights for Safinamide back to Newron Pharmaceuticals). Results are not available in the source record.
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 first intervention, i.e., change in the dose of Dopamine (DA) agonist, addition of another DA-agonist, levodopa, or other Parkinson Disease (PD) therapy, or discontinuation due to lack of efficacy (time frame: Week 78). 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 29 Mar 2013.