Idiopathic Parkinson's DiseasePhase 3SETTLENCT00627640
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
A Phase 3 study testing Safinimide 50-100 mg/day in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 121 sites in 21 countries.
Trial summary
Parkinson's Disease 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… 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?
- Safinimide 50-100 mg/day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 549 participants
- Where
- 121 sitesin 21 countries
- Study dates
- Feb 2009to Mar 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
- Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.
- Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.
- Have motor fluctuations, with >1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)
Who cannot join
- 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;.
- Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
- Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
- Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.
- Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
Trial locations and contacts
121 sites in 21 countries.
121 sites in 21 countries
United States28 sites
Parkinson's Disease and Movement Disorder Center
Albany, New York
Wesley Woods Geriatric Center
Atlanta, Georgia
University of Maryland Medical Center
Baltimore, Maryland
Quest Research Institute
Bingham Farms, Michigan
University of Alabama at Birmingham
Birmingham, Alabama
Parkinson's Disease and Movement Disorder Center
Boca Raton, Florida
Boston University School of Medicine
Boston, Massachusetts
The Neurological Institute
Charlotte, North Carolina
Northwestern University PD and Movement Disorders Center
Chicago, Illinois
Rush University Medical Center
Chicago, Illinois
Columbus Research Institute
Columbus, Georgia
Duke Movement Disorders Clinic
Durham, North Carolina
Neurologic Consultants P.A.
Fort Lauderdale, Florida
University of Florida
Gainesville, Florida
Baylor College of Medicine
Houston, Texas
University of Kansas Medical Center
Kansas City, Kansas
North Shore Medical Center
Manhasset, New York
Vanderbilt University Medical Center
Nashville, Tennessee
Institute for Neurodegenerative Disorders
New Haven, Connecticut
Neurological Institute of New York
New York, New York
Pennsylvania Hospital
Philadelphia, Pennsylvania
Barrow Neurological Institute
Phoenix, Arizona
Parkinson's Disease Treatment Center of SW Florida
Port Charlotte, Florida
San Francisco Clinical Research Center
San Francisco, California
Mayo Clinic Scottsdale
Scottsdale, Arizona
Parkinson's Institute
Sunnyvale, California
Neurology Clinical Research Inc.
Sunrise, Florida
University Of South Florida Medical Center
Tampa, Florida
Germany12 sites
Kliniken Beelitz GmbH
Beelitz-Heilstätten
Charité Campus Virchow Universitaetsmedizin Berlin
Berlin
Ehret Reinhard
Berlin
St. Joseph-Krankenhaus Berlin-Weißensee
Berlin
Universitaetsklinikum Goettingen
Göttingen
Arzneimittelforschung Leipzig GmbH
Leipzig
Philipps-Universitaet Marburg
Marburg
Praxis Dipl med Bodenschatz
Mittweida
Neurologisches Krankenhaus Muenchen
München
Eberhard-Karls-Universität
Tübingen
Universitätsklinikum
Ulm
Deutsche Klinik fuer Diagnostik
Wiesbaden
Hungary12 sites
Clinexpert Kereskedelmi es Szolgaltato Kft.
Budapest
Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
Budapest
Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály
Budapest
Nyiro Gyula Korhaz
Budapest
Semmelweis Egyetem
Budapest
SOTE Neurlogia
Budapest
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
Debrecen
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc
DE OEC Neurologiai Klinika
Móricz
Peterfy S. Utcai Korhaz
Peterfy Sandor
Sopron Medical Egeszsegugyi Szolgaltato Kft.
Sopron
BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke
Szentpetri
India8 sites
M. S. Ramaiah Medical College and Hospital
Bangalore, Karna
Nizam's Institute of Medical Sciences
Hyderabad, Andh Prad
Mallikatta Neuro and Research Centre
Mangalore
BYL Nair Hospital ¬ TN Medical College
Mumbai Mahara
Brain & Mind Institute
Nagpur
All India Institute of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi
Christian Medical College Hospital
Vellore
King George Hospital
Visakhapatnam, Andh Prad
Belgium6 sites
Cliniques Universitaires Saint-Luc
Brussels
U.Z Antwerpen
Edegem
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt
ZNA Hoge Beuken
Hoboken
Heilig Hart Roeselare - Campus westlaan
Roeselare
AZ Sint-Augustinus
Wilrijk
Canada6 sites
Research Site
Halifax, Nova Scotia
King David
Halifax
Kingston General Hospital
Kingston
Parkinson's and Neurodegenerative Disorders Clinic
Ottawa, Ontario
Dynamic Clinical Research Group
Pointe-Claire, Quebec
University Health Network -Toronto Western Hosp.
Toronto, Ontario
Israel6 sites
Barzilai Medical Center
Ashkelon
Rambam Health Care Campus
Haifa
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Sieff Government Hospital
Safed
Sourasky Medical Center
Tel Aviv
France5 sites
CHU Hopital Gabriel Montpied
Clermont-Ferrand
CHU La Miletrie
Miletrie Poitiers
CHU Nantes Hôpital Laennec - CIC Neurologie
Nantes
CHU de Nimes, Hopital Caremeau
Nîmes
CIC-Hospital Purpan
Pavillon Riser Toulouse
Slovakia5 sites
MU Dr.Beata Dupejová neurologicka ambulancia s.r.o
Banská Bystrica
Poliklinika Tehelna
Bratislava
Vseobecna nemocnica s poliklinikou Levoca
Levoča
Fakultna nemocnica Trnava Interna klinika
Slovak Republic
Nestatne zdravotnicke zariadenie Neurologicka ambulancia
Slovak Republic
Thailand5 sites
King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
Rajavithi Hospital
Bangkok
Lampang Hospital
Lampang
Sappasithiprasong Hospital
Ubonratchathani
United Kingdom5 sites
Fylde Coast Hospital
Blackpool
Addenbrookes NHS Trust
Cambridge
Southern General Hospital
Glasgow
Royal Free Hospital
London
Clinical Ageing Research Unit
Newcastle upon Tyne
Spain4 sites
Policlinica Guipuzcoa
Donostia / San Sebastian
Fundacion Hospital de Alcorcon
Madrid
Fundacion Jimenez Diaz
Madrid
HU Carlos Haya
Málaga
New Zealand3 sites
Auckland City Hospital
Aucklan
Van der Veer Institute for Parkinson's & Brain Research
Christchurch
Waikato Hospital
Hamilton
South Korea3 sites
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Severance Hospital, Yonsei University College of Medicine
Seoul
Taiwan3 sites
Chang-Hua Christian Hospital
Chang-hua
Kaohsiung Veterans General Hospital
Kaohsiung City
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Australia2 sites
Concord Repatriation General Hospital
Concord
Central Coast Neuroscience Research
East Gosford
Malaysia2 sites
Hospital Pulau Pinang
George Town
University of Malaya Medical Center
Kuala Lumpur
Switzerland2 sites
Inselspital Bern
Bern
Hopitaux Universitaires de Geneve - Hug
Geneva
About this study
Official title: A Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine
Parkinson's Disease 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 man.
Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.
The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Safinimide 50-100 mg/day, Matching 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.
Safinimide 50-100 mg/dayDrug
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Matching PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1 active (50 - 100 mg/day) Receives: Drug: Safinimide 50-100 mg/day |
| 2 | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)
Measured: 24 weeks
Secondary outcomes (1)
Evaluate the changes from baseline to W24 in Activities of Daily Living, cognition, dyskinesias, change in global clinical status, motor symptoms, motor fluctuations, change in levopoda dose and Health Related Quality of life
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 549 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newron Pharmaceuticals SPA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Algirdas Kakarieka, MD, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627640
- Sponsor's protocol ID
- 27919
- Other IDs
- IND: 63,901, EudraCT Number: 2007-002964-90
- Acronym
- SETTLE
- Status last verified
- Jun 2012
- First submitted
- 13 Feb 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
Publications
Cattaneo C, Kulisevsky J. The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Adv Ther. 2024 Feb;41(2):638-648. doi: 10.1007/s12325-023-02736-2. Epub 2023 Dec 9.
PubMed 38070039Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467.
PubMed 27942720
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, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or Amantadine
- ClinicalTrials.gov ID
- NCT00627640
- Acronym / sponsor ID
- SETTLE / 27919
- Conditions
- Idiopathic Parkinson's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 549 participants (actual)
- Lead sponsor
- Newron Pharmaceuticals SPAIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 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.
Parkinson's Disease 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 man.
Safinamide is an inhibitor of MAO-B. This is a phase III trial to evaluate the efficacy and safety of safinamide (50 and 100 mg p.o. q.a.m.) compared to placebo as add-on therapy to a stable dose to levodopa in subjects with advance idiopathic Parkinson's Disease.
The principal efficacy measure is the increase in mean daily "on" time during the 18-hr diary recording period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Safinimide 50-100 mg/day1 active (50 - 100 mg/day) |
| 2 | Placebo comparator | Drug: Matching 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)
- Male and female between the ages of 30 to 80 years with diagnosis of idiopathic Parkinson's Disease of more than 5 years duration, with a Hoehn and Yahr stage of I-IV during an "off" phase.
- Be levodopa-responsive and have been receiving treatment with a stable dose of levodopa for at least 4 weeks.
- Have motor fluctuations, with >1.5 hours "off" time during the day. Be able to maintain an accurate and complete diary (18-hour)
Key exclusion criteria (5 listed)
- 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;.
- Be in a late stage of Parkinson's Disease, and experiencing severe, disabling peak-dose or biphasic dyskinesia and/or unpredictable or widely swinging fluctuations in their symptoms.
- Current diagnosis of substance abuse or history of alcohol or drug abuse in the past 3 months.
- Have received treatment with safinamide previously. History of, or current depression psychosis (e.g. schizophrenia or psychotic depression) Evidence of dementia or cognitive dysfunction. History of allergic response to anticonvulsants, levodopa, or other anti-Parkinsonian agents.
- Hypersensitivity or contraindications to MAO-B inhibitors. Ophthalmologic history including any of the following conditions: albino subjects, family history of hereditary retinal disease, progressive and/or severe diminution of visual acuity (i.e., 20/70), retinitis pigmentosa, retinal pigmentation due to any cause, any active retinopathy or ocular inflammation (uveitis), or diabetic retinopathy.
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 |
|---|---|---|
| Safinimide 50-100 mg/daySafinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative | Drug | 1 |
| Matching PlaceboMatching Placebo | Drug | 2 |
Primary outcome
Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)
Time frame: 24 weeks
1 secondary outcome
Evaluate the changes from baseline to W24 in Activities of Daily Living, cognition, dyskinesias, change in global clinical status, motor symptoms, motor fluctuations, change in levopoda dose and Health Related Quality of life
Time frame: 24 weeks
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 29 Mar 2013.
- Derived from this study: PubMed 38070039Cattaneo C, Kulisevsky J. The Effects of Safinamide in Chinese and Non-Chinese Patients with Parkinson's Disease. Adv Ther. 2024 Feb;41(2):638-648. doi: 10.1007/s12325-023-02736-2. Epub 2023 Dec 9.
- Derived from this study: PubMed 27942720Schapira AH, Fox SH, Hauser RA, Jankovic J, Jost WH, Kenney C, Kulisevsky J, Pahwa R, Poewe W, Anand R. Assessment of Safety and Efficacy of Safinamide as a Levodopa Adjunct in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol. 2017 Feb 1;74(2):216-224. doi: 10.1001/jamaneurol.2016.4467.
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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.
Algirdas Kakarieka, MD study director
Merck Serono S.A., Geneva
121 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safinimide 50-100 mg/day in people with Idiopathic Parkinson's Disease, run by Newron Pharmaceuticals SPA at 121 sites in 21 countries.
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 5 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 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 121 sites in United States, Germany, Hungary, India, Belgium and 16 more countries. 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 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?
Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia) (time frame: 24 weeks). 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 NCT00627640, which also lists 2 linked publications.
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.