Protocol of a randomised delayed-start double-blind placebo-controlled multi-centre trial for Levodopa in EArly Parkinson’s disease: the LEAP-study
Identifieur interne : 000568 ( Main/Exploration ); précédent : 000567; suivant : 000569Protocol of a randomised delayed-start double-blind placebo-controlled multi-centre trial for Levodopa in EArly Parkinson’s disease: the LEAP-study
Auteurs : Constant V. M. Verschuur [Pays-Bas] ; S. R. Suwijn [Pays-Bas] ; B. Post [Pays-Bas] ; M. Dijkgraaf [Pays-Bas] ; B. R. Bloem [Pays-Bas] ; J. J. Van Hilten [Pays-Bas] ; T. Van Laar [Pays-Bas] ; G. Tissingh [Pays-Bas] ; G. Deuschl [Allemagne] ; A. E. Lang [Canada] ; R. J. De Haan [Pays-Bas] ; R. M. A. De Bie [Pays-Bas]Source :
- BMC Neurology [ 1471-2377 ] ; 2015.
Descripteurs français
- Wicri :
- geographic : Pays-Bas.
English descriptors
- KwdEn :
- Antiparkinson Agents (therapeutic use), Carbidopa (therapeutic use), Cost-Benefit Analysis, Disease Progression, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Humans, Levodopa (therapeutic use), Netherlands, Parkinson Disease (drug therapy), Quality of Life, Time-to-Treatment.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Carbidopa, Levodopa.
- geographic : Netherlands.
- drug therapy : Parkinson Disease.
- Cost-Benefit Analysis, Disease Progression, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Humans, Quality of Life, Time-to-Treatment.
Abstract
The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson’s disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs. Additionally, cost-effectiveness and cost-utility of early levodopa treatment will be assessed.
To differentiate between the direct symptomatic effects and possible disease modifying effects of levodopa, we use a randomised delayed-start double-blind placebo-controlled multi-centre trial design. Patients with early stage PD whose functional health does not yet necessitate initiation of PD-medication will be randomised to either 40 weeks of treatment with levodopa/carbidopa 100/25 mg TID including 2 weeks of dose escalation or to 40 weeks placebo TID. Subsequently, all patients receive levodopa/carbidopa 100/25 mg TID for 40 weeks. There are 8 assessments: at baseline and at 4, 22, 40, 44, 56, 68, and 80 weeks. The primary outcome measure is the difference in the mean total Unified Parkinson’s Disease Rating Scale scores between the early- and delayed-start groups at 80 weeks. Secondary outcome measures are rate of progression, the AMC Linear Disability Score, side effects, perceived quality of life with the Parkinson’s Disease Questionnaire-39, the European Quality of Life-5 Dimensions (EQ-5D), ability to (maintain) work, the use of (informal) care, caregiver burden, and costs. 446 newly diagnosed PD patients without impaired functional health need to be recruited in order to detect a minimal clinical relevant difference of 4 points on the total UPDRS at 80 weeks.
The LEAP-study will provide insights into the possible disease modifying effects of early levodopa.
Url:
DOI: 10.1186/s12883-015-0491-1
PubMed: 26584951
PubMed Central: 4653886
Affiliations:
- Allemagne, Canada, Pays-Bas
- Groningue (province), Gueldre, Hollande-Méridionale, Hollande-Septentrionale, Ontario, Schleswig-Holstein
- Amsterdam, Groningue, Kiel, Leyde, Nimègue, Toronto
- Université d'Amsterdam, Université de Toronto
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Le document en format XML
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Van Laar</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Department of Neurology, University Medical Center Groningen, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, University Medical Center Groningen, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Tissingh, G" sort="Tissingh, G" uniqKey="Tissingh G" first="G." last="Tissingh">G. 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M." last="Verschuur">Constant V. M. Verschuur</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam</wicri:regionArea><orgName type="university">Université d'Amsterdam</orgName><placeName><settlement type="city">Amsterdam</settlement><region>Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Suwijn, S R" sort="Suwijn, S R" uniqKey="Suwijn S" first="S. R." last="Suwijn">S. R. Suwijn</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam</wicri:regionArea><orgName type="university">Université d'Amsterdam</orgName><placeName><settlement type="city">Amsterdam</settlement><region>Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Post, B" sort="Post, B" uniqKey="Post B" first="B." last="Post">B. Post</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Dijkgraaf, M" sort="Dijkgraaf, M" uniqKey="Dijkgraaf M" first="M." last="Dijkgraaf">M. Dijkgraaf</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Academic Medical Center, Clinical Research Unit, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Academic Medical Center, Clinical Research Unit, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="Bloem, B R" sort="Bloem, B R" uniqKey="Bloem B" first="B. R." last="Bloem">B. R. Bloem</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen</wicri:regionArea><placeName><settlement type="city">Nimègue</settlement><region type="province" nuts="2">Gueldre</region></placeName></affiliation></author><author><name sortKey="Van Hilten, J J" sort="Van Hilten, J J" uniqKey="Van Hilten J" first="J. J." last="Van Hilten">J. J. Van Hilten</name><affiliation wicri:level="3"><nlm:aff id="Aff4">Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Leiden University Medical Center, Leiden</wicri:regionArea><placeName><settlement type="city">Leyde</settlement><region nuts="2" type="province">Hollande-Méridionale</region></placeName></affiliation></author><author><name sortKey="Van Laar, T" sort="Van Laar, T" uniqKey="Van Laar T" first="T." last="Van Laar">T. Van Laar</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Department of Neurology, University Medical Center Groningen, Groningen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, University Medical Center Groningen, Groningen</wicri:regionArea><placeName><settlement type="city">Groningue</settlement><region nuts="2" type="province">Groningue (province)</region></placeName></affiliation></author><author><name sortKey="Tissingh, G" sort="Tissingh, G" uniqKey="Tissingh G" first="G." last="Tissingh">G. Tissingh</name><affiliation wicri:level="1"><nlm:aff id="Aff6">Department of Neurology, Atrium-Orbis Medical Center Heerlen/Sittard, Heerlen, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Atrium-Orbis Medical Center Heerlen/Sittard, Heerlen</wicri:regionArea><wicri:noRegion>Heerlen</wicri:noRegion></affiliation></author><author><name sortKey="Deuschl, G" sort="Deuschl, G" uniqKey="Deuschl G" first="G." last="Deuschl">G. Deuschl</name><affiliation wicri:level="3"><nlm:aff id="Aff7">Department of Neurology, University Medical Center Schleswig-Holstein, Kiel, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Neurology, University Medical Center Schleswig-Holstein, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Lang, A E" sort="Lang, A E" uniqKey="Lang A" first="A. E." last="Lang">A. E. Lang</name><affiliation wicri:level="4"><nlm:aff id="Aff8">The Edmond J. Safra Program in Parkinson’s Disease and Morton and Gloria Shulman Movement Disorders Center, Toronto Western Hospital, University of Toronto, Toronto, Ontario Canada</nlm:aff><orgName type="university">Université de Toronto</orgName><country>Canada</country><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="De Haan, R J" sort="De Haan, R J" uniqKey="De Haan R" first="R. J." last="De Haan">R. J. De Haan</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Academic Medical Center, Clinical Research Unit, Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Academic Medical Center, Clinical Research Unit, Amsterdam</wicri:regionArea><placeName><settlement type="city">Amsterdam</settlement><region nuts="2" type="province">Hollande-Septentrionale</region></placeName></affiliation></author><author><name sortKey="De Bie, R M A" sort="De Bie, R M A" uniqKey="De Bie R" first="R. M. A." last="De Bie">R. M. A. De Bie</name><affiliation wicri:level="4"><nlm:aff id="Aff1">Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Neurology, Academic Medical Center, University of Amsterdam, PO BOX 22600, 1100 DD Amsterdam</wicri:regionArea><orgName type="university">Université d'Amsterdam</orgName><placeName><settlement type="city">Amsterdam</settlement><region>Hollande-Septentrionale</region></placeName></affiliation></author></analytic><series><title level="j">BMC Neurology</title><idno type="eISSN">1471-2377</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (therapeutic use)</term><term>Cost-Benefit Analysis</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Netherlands</term><term>Parkinson Disease (drug therapy)</term><term>Quality of Life</term><term>Time-to-Treatment</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Netherlands</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Cost-Benefit Analysis</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Humans</term><term>Quality of Life</term><term>Time-to-Treatment</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Pays-Bas</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson’s disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs. Additionally, cost-effectiveness and cost-utility of early levodopa treatment will be assessed.</p></sec><sec><title>Methods</title><p>To differentiate between the direct symptomatic effects and possible disease modifying effects of levodopa, we use a randomised delayed-start double-blind placebo-controlled multi-centre trial design. Patients with early stage PD whose functional health does not yet necessitate initiation of PD-medication will be randomised to either 40 weeks of treatment with levodopa/carbidopa 100/25 mg TID including 2 weeks of dose escalation or to 40 weeks placebo TID. Subsequently, all patients receive levodopa/carbidopa 100/25 mg TID for 40 weeks. There are 8 assessments: at baseline and at 4, 22, 40, 44, 56, 68, and 80 weeks. The primary outcome measure is the difference in the mean total Unified Parkinson’s Disease Rating Scale scores between the early- and delayed-start groups at 80 weeks. Secondary outcome measures are rate of progression, the AMC Linear Disability Score, side effects, perceived quality of life with the Parkinson’s Disease Questionnaire-39, the European Quality of Life-5 Dimensions (EQ-5D), ability to (maintain) work, the use of (informal) care, caregiver burden, and costs. 446 newly diagnosed PD patients without impaired functional health need to be recruited in order to detect a minimal clinical relevant difference of 4 points on the total UPDRS at 80 weeks.</p></sec><sec><title>Discussion</title><p>The LEAP-study will provide insights into the possible disease modifying effects of early levodopa.</p></sec><sec><title>Trial registration</title><p><ext-link ext-link-type="uri" xlink:href="http://www.isrctn.com/ISRCTN30518857">ISRCTN30518857</ext-link>, EudraCT number 2011-000678-72</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Lewitt, Pa" uniqKey="Lewitt P">PA 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M." last="Verschuur">Constant V. M. Verschuur</name></region><name sortKey="Bloem, B R" sort="Bloem, B R" uniqKey="Bloem B" first="B. R." last="Bloem">B. R. Bloem</name><name sortKey="De Bie, R M A" sort="De Bie, R M A" uniqKey="De Bie R" first="R. M. A." last="De Bie">R. M. A. De Bie</name><name sortKey="De Haan, R J" sort="De Haan, R J" uniqKey="De Haan R" first="R. J." last="De Haan">R. J. De Haan</name><name sortKey="Dijkgraaf, M" sort="Dijkgraaf, M" uniqKey="Dijkgraaf M" first="M." last="Dijkgraaf">M. Dijkgraaf</name><name sortKey="Post, B" sort="Post, B" uniqKey="Post B" first="B." last="Post">B. Post</name><name sortKey="Suwijn, S R" sort="Suwijn, S R" uniqKey="Suwijn S" first="S. R." last="Suwijn">S. R. Suwijn</name><name sortKey="Tissingh, G" sort="Tissingh, G" uniqKey="Tissingh G" first="G." last="Tissingh">G. Tissingh</name><name sortKey="Van Hilten, J J" sort="Van Hilten, J J" uniqKey="Van Hilten J" first="J. J." last="Van Hilten">J. J. Van Hilten</name><name sortKey="Van Laar, T" sort="Van Laar, T" uniqKey="Van Laar T" first="T." last="Van Laar">T. Van Laar</name></country><country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Deuschl, G" sort="Deuschl, G" uniqKey="Deuschl G" first="G." last="Deuschl">G. Deuschl</name></region></country><country name="Canada"><region name="Ontario"><name sortKey="Lang, A E" sort="Lang, A E" uniqKey="Lang A" first="A. E." last="Lang">A. E. Lang</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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