Clinical trial NCT00627640: Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to Levodopa
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 549
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Evaluate the change from baseline to W24 in daily "on" time ("on" time without dyskinesia plus "on" time with minor dyskinesia)
timeFrame: 24 weeks
Secondary outcomes:
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Sunnyvale
country: United States
facility: Parkinson's Institute
state: California
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorder Center
state: Florida
city: Fort Lauderdale
country: United States
facility: Neurologic Consultants P.A.
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Port Charlotte
country: United States
facility: Parkinson's Disease Treatment Center of SW Florida
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research Inc.
state: Florida
city: Tampa
country: United States
facility: University Of South Florida Medical Center
state: Florida
city: Atlanta
country: United States
facility: Wesley Woods Geriatric Center
state: Georgia
city: Columbus
country: United States
facility: Columbus Research Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestern University PD and Movement Disorders Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Albany
country: United States
facility: Parkinson's Disease and Movement Disorder Center
state: New York
city: Manhasset
country: United States
facility: North Shore Medical Center
state: New York
city: New York
country: United States
facility: Neurological Institute of New York
state: New York
city: Charlotte
country: United States
facility: The Neurological Institute
state: North Carolina
city: Durham
country: United States
facility: Duke Movement Disorders Clinic
state: North Carolina
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
city: East Gosford
country: Australia
facility: Central Coast Neuroscience Research
city: Graz
country: Austria
facility: Univ.Klinik Graz
city: Innsbruck
country: Austria
facility: Univ.Klinik Innsbruck
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: U.Z Antwerpen
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis - Campus Virga Jesse
city: Hoboken
country: Belgium
facility: ZNA Hoge Beuken
city: Roeselare
country: Belgium
facility: Heilig Hart Roeselare - Campus westlaan
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Ottawa
country: Canada
facility: Parkinson's and Neurodegenerative Disorders Clinic
state: Ontario
city: Toronto
country: Canada
facility: University Health Network -Toronto Western Hosp.
state: Ontario
city: Pointe Claire
country: Canada
facility: Dynamic Clinical Research Group
state: Quebec
city: Halifax
country: Canada
facility: King David
city: Kingston
country: Canada
facility: Kingston General Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Clermont Ferrand
country: France
facility: CHU Hopital Gabriel Montpied
city: Miletrie Poitiers
country: France
facility: CHU La Miletrie
city: Nantes Cedex
country: France
facility: CHU Nantes Hôpital Laennec - CIC Neurologie
city: Nimes Cedex
country: France
facility: CHU de Nimes, Hopital Caremeau
city: Pavillon Riser Toulouse
country: France
facility: CIC-Hospital Purpan
city: Beelitz-Heilstaetten
country: Germany
facility: Kliniken Beelitz GmbH
city: Berlin
country: Germany
facility: Charité Campus Virchow Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Ehret Reinhard
city: Berlin
country: Germany
facility: St. Joseph-Krankenhaus Berlin-Weißensee
city: Goettingen
country: Germany
facility: Universitaetsklinikum Goettingen
city: Leipzig
country: Germany
facility: Arzneimittelforschung Leipzig GmbH
city: Marburg
country: Germany
facility: Philipps-Universitaet Marburg
city: Mittweida
country: Germany
facility: Praxis Dipl med Bodenschatz
city: Muenchen
country: Germany
facility: Neurologisches Krankenhaus Muenchen
city: Tubingen
country: Germany
facility: Eberhard-Karls-Universität
city: Ulm
country: Germany
facility: Universitätsklinikum
city: Wiesbaden
country: Germany
facility: Deutsche Klinik fuer Diagnostik
city: Budapest
country: Hungary
facility: Clinexpert Kereskedelmi es Szolgaltato Kft.
city: Budapest
country: Hungary
facility: Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
city: Budapest
country: Hungary
facility: Fővárosi Önkormányzat Nyírő Gyula Kórhaz Neurologiai Osztály
city: Budapest
country: Hungary
facility: Nyiro Gyula Korhaz
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: SOTE Neurlogia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
city: Móricz
country: Hungary
facility: DE OEC Neurologiai Klinika
city: Peterfy Sandor
country: Hungary
facility: Peterfy S. Utcai Korhaz
city: Sopron
country: Hungary
facility: Sopron Medical Egeszsegugyi Szolgaltato Kft.
city: Szentpetri
country: Hungary
facility: BAZ Country Hospital and Outpatient Clinic Dept. of Neurology Toxicology and Stroke
city: Hyderabad
country: India
facility: Nizam's Institute of Medical Sciences
state: Andh Prad
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andh Prad
city: New Delhi
country: India
facility: All India Institute of Medical Sciences (AIIMS)
state: Delhi
city: Bangalore
country: India
facility: M. S. Ramaiah Medical College and Hospital
state: Karna
city: Mangalore
country: India
facility: Mallikatta Neuro and Research Centre
city: Mumbai Mahara
country: India
facility: BYL Nair Hospital ¬ TN Medical College
city: Nagpur
country: India
facility: Brain & Mind Institute
city: Vellore
country: India
facility: Christian Medical College Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Zefat
country: Israel
facility: Sieff Government Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University College of Medicine
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Center
city: Pinang
country: Malaysia
facility: Hospital Pulau Pinang
city: Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Aucklan
country: New Zealand
facility: Auckland City Hospital
city: Christchurch
country: New Zealand
facility: Van der Veer Institute for Parkinson's & Brain Research
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Banska Bystrica
country: Slovakia
facility: MU Dr.Beata Dupejová neurologicka ambulancia s.r.o
city: Bratislava
country: Slovakia
facility: Poliklinika Tehelna
city: Levoca
country: Slovakia
facility: Vseobecna nemocnica s poliklinikou Levoca
city: Slovak Republic
country: Slovakia
facility: Fakultna nemocnica Trnava Interna klinika
city: Slovak Republic
country: Slovakia
facility: Nestatne zdravotnicke zariadenie Neurologicka ambulancia
city: Madrid
country: Spain
facility: Fundacion Hospital de Alcorcon
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Malaga
country: Spain
facility: HU Carlos Haya
city: San Sebastian
country: Spain
facility: Policlinica Guipuzcoa
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve - Hug
city: Chang Hua
country: Taiwan
facility: Chang-Hua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Lampang
country: Thailand
facility: Lampang Hospital
city: Ubonratchathani
country: Thailand
facility: Sappasithiprasong Hospital
city: Blackpool
country: United Kingdom
facility: Fylde Coast Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes NHS Trust
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Clinical Ageing Research Unit
Study officials:
affiliation: Merck Serono S.A., Geneva
name: Algirdas Kakarieka, MD
role: STUDY_DIRECTOR
References:
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.