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Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa (SETTLE)

Primary Purpose

Idiopathic Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Safinimide 50-100 mg/day
Matching Placebo
Sponsored by
Newron Pharmaceuticals SPA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Barrow Neurological Institute
  • Mayo Clinic Scottsdale
  • San Francisco Clinical Research Center
  • Parkinson's Institute
  • Institute for Neurodegenerative Disorders
  • Parkinson's Disease and Movement Disorder Center
  • Neurologic Consultants P.A.
  • University of Florida
  • Parkinson's Disease Treatment Center of SW Florida
  • Neurology Clinical Research Inc.
  • University Of South Florida Medical Center
  • Wesley Woods Geriatric Center
  • Columbus Research Institute
  • Northwestern University PD and Movement Disorders Center
  • Rush University Medical Center
  • University of Kansas Medical Center
  • University of Maryland Medical Center
  • Boston University School of Medicine
  • Quest Research Institute
  • Parkinson's Disease and Movement Disorder Center
  • North Shore Medical Center
  • Neurological Institute of New York
  • The Neurological Institute
  • Duke Movement Disorders Clinic
  • Pennsylvania Hospital
  • Vanderbilt University Medical Center
  • Baylor College of Medicine
  • Concord Repatriation General Hospital
  • Central Coast Neuroscience Research
  • Univ.Klinik Graz
  • Univ.Klinik Innsbruck
  • Cliniques Universitaires Saint-Luc
  • U.Z Antwerpen
  • Jessa Ziekenhuis - Campus Virga Jesse
  • ZNA Hoge Beuken
  • Heilig Hart Roeselare - Campus westlaan
  • AZ Sint-Augustinus
  • Research Site
  • Parkinson's and Neurodegenerative Disorders Clinic
  • University Health Network -Toronto Western Hosp.
  • Dynamic Clinical Research Group
  • King David
  • Kingston General Hospital
  • Tartu University Hospital
  • CHU Hopital Gabriel Montpied
  • CHU La Miletrie
  • CHU Nantes Hôpital Laennec - CIC Neurologie
  • CHU de Nimes, Hopital Caremeau
  • CIC-Hospital Purpan
  • Kliniken Beelitz GmbH
  • Charité Campus Virchow Universitaetsmedizin Berlin
  • Ehret Reinhard
  • St. Joseph-Krankenhaus Berlin-Weißensee
  • Universitaetsklinikum Goettingen
  • Arzneimittelforschung Leipzig GmbH
  • Philipps-Universitaet Marburg
  • Praxis Dipl med Bodenschatz
  • Neurologisches Krankenhaus Muenchen
  • Eberhard-Karls-Universität
  • Universitätsklinikum
  • Deutsche Klinik fuer Diagnostik
  • Clinexpert Kereskedelmi es Szolgaltato Kft.
  • Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
  • Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály
  • Nyiro Gyula Korhaz
  • Semmelweis Egyetem
  • SOTE Neurlogia
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
  • DE OEC Neurologiai Klinika
  • Peterfy S. Utcai Korhaz
  • Sopron Medical Egeszsegugyi Szolgaltato Kft.
  • BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke
  • Nizam's Institute of Medical Sciences
  • King George Hospital
  • All India Institute of Medical Sciences (AIIMS)
  • M. S. Ramaiah Medical College and Hospital
  • Mallikatta Neuro and Research Centre
  • BYL Nair Hospital ¬ TN Medical College
  • Brain & Mind Institute
  • Christian Medical College Hospital
  • Barzilai Medical Center
  • Rambam Health Care Campus
  • Rabin Medical Center
  • Sheba Medical Center
  • Sourasky Medical Center
  • Sieff Government Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Severance Hospital, Yonsei University College of Medicine
  • University of Malaya Medical Center
  • Hospital Pulau Pinang
  • Jeroen Bosch Ziekenhuis
  • Auckland City Hospital
  • Van der Veer Institute for Parkinson's & Brain Research
  • Waikato Hospital
  • MU Dr.Beata Dupejová neurologicka ambulancia s.r.o
  • Poliklinika Tehelna
  • Vseobecna nemocnica s poliklinikou Levoca
  • Fakultna nemocnica Trnava Interna klinika
  • Nestatne zdravotnicke zariadenie Neurologicka ambulancia
  • Fundacion Hospital de Alcorcon
  • Fundacion Jimenez Diaz
  • HU Carlos Haya
  • Policlinica Guipuzcoa
  • Inselspital Bern
  • Hopitaux Universitaires de Geneve - Hug
  • Chang-Hua Christian Hospital
  • Kaohsiung Veterans General Hospital
  • Shin Kong Wu Ho-Su Memorial Hospital
  • King Chulalongkorn Memorial Hospital
  • Phramongkutklao Hospital
  • Rajavithi Hospital
  • Lampang Hospital
  • Sappasithiprasong Hospital
  • Fylde Coast Hospital
  • Addenbrookes NHS Trust
  • Southern General Hospital
  • Royal Free Hospital
  • Clinical Ageing Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

1 active (50 - 100 mg/day)

Outcomes

Primary Outcome Measures

Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)

Secondary Outcome Measures

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

Full Information

First Posted
February 13, 2008
Last Updated
March 27, 2013
Sponsor
Newron Pharmaceuticals SPA
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1. Study Identification

Unique Protocol Identification Number
NCT00627640
Brief Title
Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
Acronym
SETTLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newron Pharmaceuticals SPA

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
549 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1 active (50 - 100 mg/day)
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Safinimide 50-100 mg/day
Intervention Description
Safinamide, (S)-(+)-2-[4-(3-fluorobenzyloxy) benzylamino] propanamide methanesulfonate, is an a-aminoamide derivative
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Algirdas Kakarieka, MD
Organizational Affiliation
Merck Serono S.A., Geneva
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
Country
United States
Facility Name
Parkinson's Institute
City
Sunnyvale
State/Province
California
Country
United States
Facility Name
Institute for Neurodegenerative Disorders
City
New Haven
State/Province
Connecticut
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Neurologic Consultants P.A.
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Parkinson's Disease Treatment Center of SW Florida
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
Neurology Clinical Research Inc.
City
Sunrise
State/Province
Florida
Country
United States
Facility Name
University Of South Florida Medical Center
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Wesley Woods Geriatric Center
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Columbus Research Institute
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
Northwestern University PD and Movement Disorders Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Quest Research Institute
City
Bingham Farms
State/Province
Michigan
Country
United States
Facility Name
Parkinson's Disease and Movement Disorder Center
City
Albany
State/Province
New York
Country
United States
Facility Name
North Shore Medical Center
City
Manhasset
State/Province
New York
Country
United States
Facility Name
Neurological Institute of New York
City
New York
State/Province
New York
Country
United States
Facility Name
The Neurological Institute
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Duke Movement Disorders Clinic
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
Country
Australia
Facility Name
Central Coast Neuroscience Research
City
East Gosford
Country
Australia
Facility Name
Univ.Klinik Graz
City
Graz
Country
Austria
Facility Name
Univ.Klinik Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Facility Name
U.Z Antwerpen
City
Edegem
Country
Belgium
Facility Name
Jessa Ziekenhuis - Campus Virga Jesse
City
Hasselt
Country
Belgium
Facility Name
ZNA Hoge Beuken
City
Hoboken
Country
Belgium
Facility Name
Heilig Hart Roeselare - Campus westlaan
City
Roeselare
Country
Belgium
Facility Name
AZ Sint-Augustinus
City
Wilrijk
Country
Belgium
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Parkinson's and Neurodegenerative Disorders Clinic
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
University Health Network -Toronto Western Hosp.
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Dynamic Clinical Research Group
City
Pointe Claire
State/Province
Quebec
Country
Canada
Facility Name
King David
City
Halifax
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
Country
Canada
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Facility Name
CHU Hopital Gabriel Montpied
City
Clermont Ferrand
Country
France
Facility Name
CHU La Miletrie
City
Miletrie Poitiers
Country
France
Facility Name
CHU Nantes Hôpital Laennec - CIC Neurologie
City
Nantes Cedex
Country
France
Facility Name
CHU de Nimes, Hopital Caremeau
City
Nimes Cedex
Country
France
Facility Name
CIC-Hospital Purpan
City
Pavillon Riser Toulouse
Country
France
Facility Name
Kliniken Beelitz GmbH
City
Beelitz-Heilstaetten
Country
Germany
Facility Name
Charité Campus Virchow Universitaetsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Ehret Reinhard
City
Berlin
Country
Germany
Facility Name
St. Joseph-Krankenhaus Berlin-Weißensee
City
Berlin
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Goettingen
Country
Germany
Facility Name
Arzneimittelforschung Leipzig GmbH
City
Leipzig
Country
Germany
Facility Name
Philipps-Universitaet Marburg
City
Marburg
Country
Germany
Facility Name
Praxis Dipl med Bodenschatz
City
Mittweida
Country
Germany
Facility Name
Neurologisches Krankenhaus Muenchen
City
Muenchen
Country
Germany
Facility Name
Eberhard-Karls-Universität
City
Tubingen
Country
Germany
Facility Name
Universitätsklinikum
City
Ulm
Country
Germany
Facility Name
Deutsche Klinik fuer Diagnostik
City
Wiesbaden
Country
Germany
Facility Name
Clinexpert Kereskedelmi es Szolgaltato Kft.
City
Budapest
Country
Hungary
Facility Name
Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
City
Budapest
Country
Hungary
Facility Name
Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály
City
Budapest
Country
Hungary
Facility Name
Nyiro Gyula Korhaz
City
Budapest
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
Country
Hungary
Facility Name
SOTE Neurlogia
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
City
Debrecen
Country
Hungary
Facility Name
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
City
Miskolc
Country
Hungary
Facility Name
DE OEC Neurologiai Klinika
City
Móricz
Country
Hungary
Facility Name
Peterfy S. Utcai Korhaz
City
Peterfy Sandor
Country
Hungary
Facility Name
Sopron Medical Egeszsegugyi Szolgaltato Kft.
City
Sopron
Country
Hungary
Facility Name
BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke
City
Szentpetri
Country
Hungary
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
State/Province
Andh Prad
Country
India
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andh Prad
Country
India
Facility Name
All India Institute of Medical Sciences (AIIMS)
City
New Delhi
State/Province
Delhi
Country
India
Facility Name
M. S. Ramaiah Medical College and Hospital
City
Bangalore
State/Province
Karna
Country
India
Facility Name
Mallikatta Neuro and Research Centre
City
Mangalore
Country
India
Facility Name
BYL Nair Hospital ¬ TN Medical College
City
Mumbai Mahara
Country
India
Facility Name
Brain & Mind Institute
City
Nagpur
Country
India
Facility Name
Christian Medical College Hospital
City
Vellore
Country
India
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Rambam Health Care Campus
City
Haifa
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikva
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel Aviv
Country
Israel
Facility Name
Sieff Government Hospital
City
Zefat
Country
Israel
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
University of Malaya Medical Center
City
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
Pinang
Country
Malaysia
Facility Name
Jeroen Bosch Ziekenhuis
City
Hertogenbosch
Country
Netherlands
Facility Name
Auckland City Hospital
City
Aucklan
Country
New Zealand
Facility Name
Van der Veer Institute for Parkinson's & Brain Research
City
Christchurch
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
Country
New Zealand
Facility Name
MU Dr.Beata Dupejová neurologicka ambulancia s.r.o
City
Banska Bystrica
Country
Slovakia
Facility Name
Poliklinika Tehelna
City
Bratislava
Country
Slovakia
Facility Name
Vseobecna nemocnica s poliklinikou Levoca
City
Levoca
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava Interna klinika
City
Slovak Republic
Country
Slovakia
Facility Name
Nestatne zdravotnicke zariadenie Neurologicka ambulancia
City
Slovak Republic
Country
Slovakia
Facility Name
Fundacion Hospital de Alcorcon
City
Madrid
Country
Spain
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain
Facility Name
HU Carlos Haya
City
Malaga
Country
Spain
Facility Name
Policlinica Guipuzcoa
City
San Sebastian
Country
Spain
Facility Name
Inselspital Bern
City
Bern
Country
Switzerland
Facility Name
Hopitaux Universitaires de Geneve - Hug
City
Geneve
Country
Switzerland
Facility Name
Chang-Hua Christian Hospital
City
Chang Hua
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Phramongkutklao Hospital
City
Bangkok
Country
Thailand
Facility Name
Rajavithi Hospital
City
Bangkok
Country
Thailand
Facility Name
Lampang Hospital
City
Lampang
Country
Thailand
Facility Name
Sappasithiprasong Hospital
City
Ubonratchathani
Country
Thailand
Facility Name
Fylde Coast Hospital
City
Blackpool
Country
United Kingdom
Facility Name
Addenbrookes NHS Trust
City
Cambridge
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
Country
United Kingdom
Facility Name
Clinical Ageing Research Unit
City
Newcastle Upon Tyne
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27942720
Citation
Schapira 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.
Results Reference
derived

Learn more about this trial

Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa

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