Parkinson's DiseasePhase 3NCT00865579
Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
A Phase 3 study testing Safinamide in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA at 1 site in Romania.
Trial summary
Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Safinamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 964 participants
- Where
- 1 siteRomania
- Study dates
- Apr 2009to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the subject has completed a previous clinical study with Safinamide in PD
- the subject successfully completed all trial requirements of the antecedent trial
- 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 for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive
- subjects must be willing and able to participate in the trial and provide written informed consent
Who cannot join
- the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide
- if female, the subject is pregnant or lactating
- any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's Disease (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing 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 humans.
Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.
- Conditions
- Parkinson's Disease
- Being tested
- Safinamide
- Keywords
- MAO inhibitors, motor fluctuations, dyskinesia, Parkinson's Disease
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafinamideDrug
The Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm).
Trial Medication is to be taken once daily, in the morning.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects to receive first 50mg/d Safinamide with an increase of target dose of 100mg/d after 14 days of taper period until end of treatment visit. In case of any intolerance the daily dose of 100mg might be decreased to 50mg/d. Patients permanently discontinuing treatment will enter a 7day taper phase before treatment discontinuation at a dose of 50mg/day. Subjects already taking 50mg/d may stop Safinamide immediately. Receives: Drug: Safinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical Exams
Measured: Anticipated time frame up to 3 years
Change from baseline in Neurologic Exams
Measured: Anticipated time frame up to 3 years
Change from baseline in Vital Signs
Measured: Anticipated time frame up to 3 years
Change from baseline in Laboratory Evaluations
Measured: Anticipated time frame up to 3 years
Change from baseline in Electrocardiograms
Measured: Anticipated time frame up to 3 years
Summary of Participants who had Adverse Experiences
Measured: Anticipated time frame up to 3 years
Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Measured: Anticipated time frame up to 3 years
Change from baseline in Dermatologic Exams
Measured: Anticipated time frame up to 3 years
Change from baseline in Ophthalmologic Exams
Measured: Anticipated time frame up to 3 years
Secondary outcomes (3)
Change from baseline in Health Resource Utilisation
Measured: Anticipated time frame up to 3 years
Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale
Measured: Anticipated time frame up to 3 years
Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)
Measured: Anticipated time frame up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: study terminated early due to change in Sponsorship
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 964 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 Inc., an Affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865579
- Sponsor's protocol ID
- 28850
- Other IDs
- 63,901, EudraCT-Number: 2008-005492-94
- Status last verified
- Sep 2017
- First submitted
- 10 Mar 2009
- Last updated
- 18 Sep 2017
- Results posted
- No
- Individual data sharing
- No: No efficacy endpoints were analyzed in this trial.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT00865579
- Acronym / sponsor ID
- 28850
- Conditions
- Parkinson's Disease
- Keywords
- MAO inhibitors, motor fluctuations, dyskinesia, Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study terminated early due to change in Sponsorship
- Enrolment
- 964 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Apr 2009 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 19 Mar 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 (PD) is a major neurodegenerative disorder in which there is a progressive loss of dopamine-containing 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 humans.
Safinamide is an inhibitor of MAO-B. This study is to evaluate the long term safety and tolerability of safinamide in PD patients, that have already completed a previous clinical study with Safinamide. The physical and neurological conditions as well as other safety parameters will get compared from baseline to subsequent visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SafinamideAll subjects to receive first 50mg/d Safinamide with an increase of target dose of 100mg/d after 14 days of taper period until end of treatment visit. In case of any intolerance the daily dose of 100mg might be decreased to 50mg/d. Patients permanently discontinuing treatment will enter a 7day taper phase before treatment discontinuation at a dose of 50mg/day. Subjects already taking 50mg/d may stop Safinamide immediately. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the subject has completed a previous clinical study with Safinamide in PD
- the subject successfully completed all trial requirements of the antecedent trial
- 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 for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial women of child bearing potential are defined of all female subjects after puberty unless they are postmenopausal for at least two years, are surgically sterile or are sexually inactive
- subjects must be willing and able to participate in the trial and provide written informed consent
Key exclusion criteria (3 listed)
- the subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with Safinamide
- if female, the subject is pregnant or lactating
- any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject's ability to participate in this open-label trial
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 |
|---|---|---|
| SafinamideThe Investigational Medicinal Product will be provided by the Sponsor in the form of tablets at dosage strengths of safinamide 50 mg (small - 7 mm) or safinamide 100 mg (large - 9 mm). Trial Medication is to be taken once daily, in the morning. | Drug | 1 |
Primary outcome
Change from baseline in Physical Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Neurologic Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Vital Signs
Time frame: Anticipated time frame up to 3 years
Change from baseline in Laboratory Evaluations
Time frame: Anticipated time frame up to 3 years
Change from baseline in Electrocardiograms
Time frame: Anticipated time frame up to 3 years
Summary of Participants who had Adverse Experiences
Time frame: Anticipated time frame up to 3 years
Change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: Anticipated time frame up to 3 years
Change from baseline in Dermatologic Exams
Time frame: Anticipated time frame up to 3 years
Change from baseline in Ophthalmologic Exams
Time frame: Anticipated time frame up to 3 years
3 secondary outcomes
Change from baseline in Health Resource Utilisation
Time frame: Anticipated time frame up to 3 years
Change from baseline in EuroQol Group EQ-5D™ Quality of Life Scale
Time frame: Anticipated time frame up to 3 years
Change from baseline in Parkinson Disease Questionnaire 39 (PDQ-39)
Time frame: Anticipated time frame up to 3 years
Results and safety
The study was stopped early (reason given: study terminated early due to change in Sponsorship). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: No. No efficacy endpoints were analyzed in this trial.
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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 Inc., an Affiliate of Merck KGaA, Darmstadt, Germany
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 in people with Parkinson's Disease, run by Newron Pharmaceuticals SPA at 1 site in Romania.
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 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: stopped early, as of the sponsor's last update on 18 Sep 2017. 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 Romania. 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. 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: study terminated early due to change in Sponsorship). 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?
Change from baseline in Physical Exams (time frame: Anticipated time frame up to 3 years). The study lists 9 primary outcomes in all. 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 18 Sep 2017.