Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes
Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-week, placebo-controlled crossover design (Study 201; N=33) and a 12-week parallel-group design (Study 202;...
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| Veröffentlicht in: | Sleep medicine 2017-07, Vol.35, p.12-16 |
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| creator | Ruoff, Chad, MD Bogan, Richard K., MD Emsellem, Helen, MD Feldman, Neil, MD Lankford, Alan, PhD Bream, Gary, PhD Khayrallah, Moise, PhD Lu, Yuan, MS Carter, Lawrence P., PhD Black, Jed, MD |
| description | Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-week, placebo-controlled crossover design (Study 201; N=33) and a 12-week parallel-group design (Study 202; N=93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-minute MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-minute censored MWT data and compared to 40-minute MWT data. Results In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) minutes with JZP-110 versus 0.9 (6.0) minutes with placebo ( P =0.0002) for 40-minute data, and 8.9 (6.3) versus 0.4 (4.6) minutes for 20-minute censored data ( P |
| doi_str_mv | 10.1016/j.sleep.2017.03.025 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1910796330</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1389945717301740</els_id><sourcerecordid>1910796330</sourcerecordid><originalsourceid>FETCH-LOGICAL-c459t-63ebfc9854737220e06abde6a4922cf9082517045e60fad30e1d00e0e8a60e4b3</originalsourceid><addsrcrecordid>eNqFks9u1DAQxiMEoqXwBEjIRy5ZxnbiJAeQqtXyTy1UohUSF8vrTKi3WXvxOEX7CLw1Trdw4IJkybb0-2bs75uieM5hwYGrV5sFjYi7hQDeLEAuQNQPimPeNm1Z16Ae5rNsu7Kr6uaoeEK0gQzytnpcHIlW8Y436rj4tbo142SSC56FgaVrZKthQJvm28dvFyXnwJxnFxlBn4j9dOmafTLRhhF3tGenRJhXz67I-e93Bc6N8wm98RbnKl_NDQ7T6DPGLpESW6KnELMkBSaAnTs_JaSnxaPBjITP7veT4urt6nL5vjz7_O7D8vSstFXdpVJJXA-2a-uqkY0QgKDMukdlqk4IO3TQipo3UNWoYDC9BOQ9ZApbowCrtTwpXh7q7mL4MeX36K0ji-NoPIaJdDYGmk5JCRmVB9TGQBRx0LvotibuNQc9Z6A3-i4DPWegQeqcQVa9uG8wrbfY_9X8MT0Drw8A5m_eOoyabDbXYu9idl73wf2nwZt_9HZ03lkz3uAeaROm6LODmmsSGvSXeQzmKeCNzFUqkL8B8pqtlw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1910796330</pqid></control><display><type>article</type><title>Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Ruoff, Chad, MD ; Bogan, Richard K., MD ; Emsellem, Helen, MD ; Feldman, Neil, MD ; Lankford, Alan, PhD ; Bream, Gary, PhD ; Khayrallah, Moise, PhD ; Lu, Yuan, MS ; Carter, Lawrence P., PhD ; Black, Jed, MD</creator><creatorcontrib>Ruoff, Chad, MD ; Bogan, Richard K., MD ; Emsellem, Helen, MD ; Feldman, Neil, MD ; Lankford, Alan, PhD ; Bream, Gary, PhD ; Khayrallah, Moise, PhD ; Lu, Yuan, MS ; Carter, Lawrence P., PhD ; Black, Jed, MD</creatorcontrib><description>Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-week, placebo-controlled crossover design (Study 201; N=33) and a 12-week parallel-group design (Study 202; N=93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-minute MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-minute censored MWT data and compared to 40-minute MWT data. Results In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) minutes with JZP-110 versus 0.9 (6.0) minutes with placebo ( P =0.0002) for 40-minute data, and 8.9 (6.3) versus 0.4 (4.6) minutes for 20-minute censored data ( P <0.0001). In Study 202, mean changes in MWT sleep latency were 12.8 (10.3) minutes with JZP-110 versus 2.1 (7.9) minutes with placebo ( P <0.0001) for 40-minute data, and 8.9 (5.5) versus 1.1 (5.6) minutes for 20-minute censored data ( P <0.0001). In Studies 201 and 202, respectively, Cohen’s d effect sizes were large and numerically greater for 20-minute censored data (1.54 and 1.41) versus 40-minute data (1.37 and 1.17). Conclusions In patients with narcolepsy, JZP-110 significantly improved the ability to stay awake compared with placebo, with large effect sizes using both the 40-minute and 20-minute censored MWT data.</description><identifier>ISSN: 1389-9457</identifier><identifier>EISSN: 1878-5506</identifier><identifier>DOI: 10.1016/j.sleep.2017.03.025</identifier><identifier>PMID: 28619176</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Adult ; Carbamates - adverse effects ; Carbamates - therapeutic use ; Cross-Over Studies ; Female ; Humans ; JZP-110 ; Maintenance of Wakefulness Test ; Male ; Narcolepsy ; Narcolepsy - diagnosis ; Narcolepsy - drug therapy ; Neurology ; Phenylalanine - adverse effects ; Phenylalanine - analogs & derivatives ; Phenylalanine - therapeutic use ; Sleep - drug effects ; Sleep latency ; Sleep Medicine ; Time Factors ; Treatment Outcome ; Wakefulness ; Wakefulness - drug effects ; Wakefulness-Promoting Agents - adverse effects ; Wakefulness-Promoting Agents - therapeutic use</subject><ispartof>Sleep medicine, 2017-07, Vol.35, p.12-16</ispartof><rights>The Author(s)</rights><rights>2017 The Author(s)</rights><rights>Copyright © 2017 The Author(s). Published by Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c459t-63ebfc9854737220e06abde6a4922cf9082517045e60fad30e1d00e0e8a60e4b3</citedby><cites>FETCH-LOGICAL-c459t-63ebfc9854737220e06abde6a4922cf9082517045e60fad30e1d00e0e8a60e4b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1389945717301740$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28619176$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ruoff, Chad, MD</creatorcontrib><creatorcontrib>Bogan, Richard K., MD</creatorcontrib><creatorcontrib>Emsellem, Helen, MD</creatorcontrib><creatorcontrib>Feldman, Neil, MD</creatorcontrib><creatorcontrib>Lankford, Alan, PhD</creatorcontrib><creatorcontrib>Bream, Gary, PhD</creatorcontrib><creatorcontrib>Khayrallah, Moise, PhD</creatorcontrib><creatorcontrib>Lu, Yuan, MS</creatorcontrib><creatorcontrib>Carter, Lawrence P., PhD</creatorcontrib><creatorcontrib>Black, Jed, MD</creatorcontrib><title>Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes</title><title>Sleep medicine</title><addtitle>Sleep Med</addtitle><description>Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-week, placebo-controlled crossover design (Study 201; N=33) and a 12-week parallel-group design (Study 202; N=93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-minute MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-minute censored MWT data and compared to 40-minute MWT data. Results In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) minutes with JZP-110 versus 0.9 (6.0) minutes with placebo ( P =0.0002) for 40-minute data, and 8.9 (6.3) versus 0.4 (4.6) minutes for 20-minute censored data ( P <0.0001). In Study 202, mean changes in MWT sleep latency were 12.8 (10.3) minutes with JZP-110 versus 2.1 (7.9) minutes with placebo ( P <0.0001) for 40-minute data, and 8.9 (5.5) versus 1.1 (5.6) minutes for 20-minute censored data ( P <0.0001). In Studies 201 and 202, respectively, Cohen’s d effect sizes were large and numerically greater for 20-minute censored data (1.54 and 1.41) versus 40-minute data (1.37 and 1.17). Conclusions In patients with narcolepsy, JZP-110 significantly improved the ability to stay awake compared with placebo, with large effect sizes using both the 40-minute and 20-minute censored MWT data.</description><subject>Adult</subject><subject>Carbamates - adverse effects</subject><subject>Carbamates - therapeutic use</subject><subject>Cross-Over Studies</subject><subject>Female</subject><subject>Humans</subject><subject>JZP-110</subject><subject>Maintenance of Wakefulness Test</subject><subject>Male</subject><subject>Narcolepsy</subject><subject>Narcolepsy - diagnosis</subject><subject>Narcolepsy - drug therapy</subject><subject>Neurology</subject><subject>Phenylalanine - adverse effects</subject><subject>Phenylalanine - analogs & derivatives</subject><subject>Phenylalanine - therapeutic use</subject><subject>Sleep - drug effects</subject><subject>Sleep latency</subject><subject>Sleep Medicine</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Wakefulness</subject><subject>Wakefulness - drug effects</subject><subject>Wakefulness-Promoting Agents - adverse effects</subject><subject>Wakefulness-Promoting Agents - therapeutic use</subject><issn>1389-9457</issn><issn>1878-5506</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFks9u1DAQxiMEoqXwBEjIRy5ZxnbiJAeQqtXyTy1UohUSF8vrTKi3WXvxOEX7CLw1Trdw4IJkybb0-2bs75uieM5hwYGrV5sFjYi7hQDeLEAuQNQPimPeNm1Z16Ae5rNsu7Kr6uaoeEK0gQzytnpcHIlW8Y436rj4tbo142SSC56FgaVrZKthQJvm28dvFyXnwJxnFxlBn4j9dOmafTLRhhF3tGenRJhXz67I-e93Bc6N8wm98RbnKl_NDQ7T6DPGLpESW6KnELMkBSaAnTs_JaSnxaPBjITP7veT4urt6nL5vjz7_O7D8vSstFXdpVJJXA-2a-uqkY0QgKDMukdlqk4IO3TQipo3UNWoYDC9BOQ9ZApbowCrtTwpXh7q7mL4MeX36K0ji-NoPIaJdDYGmk5JCRmVB9TGQBRx0LvotibuNQc9Z6A3-i4DPWegQeqcQVa9uG8wrbfY_9X8MT0Drw8A5m_eOoyabDbXYu9idl73wf2nwZt_9HZ03lkz3uAeaROm6LODmmsSGvSXeQzmKeCNzFUqkL8B8pqtlw</recordid><startdate>20170701</startdate><enddate>20170701</enddate><creator>Ruoff, Chad, MD</creator><creator>Bogan, Richard K., MD</creator><creator>Emsellem, Helen, MD</creator><creator>Feldman, Neil, MD</creator><creator>Lankford, Alan, PhD</creator><creator>Bream, Gary, PhD</creator><creator>Khayrallah, Moise, PhD</creator><creator>Lu, Yuan, MS</creator><creator>Carter, Lawrence P., PhD</creator><creator>Black, Jed, MD</creator><general>Elsevier B.V</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20170701</creationdate><title>Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes</title><author>Ruoff, Chad, MD ; Bogan, Richard K., MD ; Emsellem, Helen, MD ; Feldman, Neil, MD ; Lankford, Alan, PhD ; Bream, Gary, PhD ; Khayrallah, Moise, PhD ; Lu, Yuan, MS ; Carter, Lawrence P., PhD ; Black, Jed, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c459t-63ebfc9854737220e06abde6a4922cf9082517045e60fad30e1d00e0e8a60e4b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Carbamates - adverse effects</topic><topic>Carbamates - therapeutic use</topic><topic>Cross-Over Studies</topic><topic>Female</topic><topic>Humans</topic><topic>JZP-110</topic><topic>Maintenance of Wakefulness Test</topic><topic>Male</topic><topic>Narcolepsy</topic><topic>Narcolepsy - diagnosis</topic><topic>Narcolepsy - drug therapy</topic><topic>Neurology</topic><topic>Phenylalanine - adverse effects</topic><topic>Phenylalanine - analogs & derivatives</topic><topic>Phenylalanine - therapeutic use</topic><topic>Sleep - drug effects</topic><topic>Sleep latency</topic><topic>Sleep Medicine</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Wakefulness</topic><topic>Wakefulness - drug effects</topic><topic>Wakefulness-Promoting Agents - adverse effects</topic><topic>Wakefulness-Promoting Agents - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ruoff, Chad, MD</creatorcontrib><creatorcontrib>Bogan, Richard K., MD</creatorcontrib><creatorcontrib>Emsellem, Helen, MD</creatorcontrib><creatorcontrib>Feldman, Neil, MD</creatorcontrib><creatorcontrib>Lankford, Alan, PhD</creatorcontrib><creatorcontrib>Bream, Gary, PhD</creatorcontrib><creatorcontrib>Khayrallah, Moise, PhD</creatorcontrib><creatorcontrib>Lu, Yuan, MS</creatorcontrib><creatorcontrib>Carter, Lawrence P., PhD</creatorcontrib><creatorcontrib>Black, Jed, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Sleep medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ruoff, Chad, MD</au><au>Bogan, Richard K., MD</au><au>Emsellem, Helen, MD</au><au>Feldman, Neil, MD</au><au>Lankford, Alan, PhD</au><au>Bream, Gary, PhD</au><au>Khayrallah, Moise, PhD</au><au>Lu, Yuan, MS</au><au>Carter, Lawrence P., PhD</au><au>Black, Jed, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes</atitle><jtitle>Sleep medicine</jtitle><addtitle>Sleep Med</addtitle><date>2017-07-01</date><risdate>2017</risdate><volume>35</volume><spage>12</spage><epage>16</epage><pages>12-16</pages><issn>1389-9457</issn><eissn>1878-5506</eissn><abstract>Abstract Objective To evaluate the effects of JZP-110 on the Maintenance of Wakefulness Test (MWT) with data censored to include only the first 20 minutes of a 40-minute MWT. Methods In a four-week, placebo-controlled crossover design (Study 201; N=33) and a 12-week parallel-group design (Study 202; N=93), JZP-110 was evaluated in narcolepsy patients using changes from baseline in the 40-minute MWT as the primary endpoint. Effect sizes based on the change from baseline in mean MWT sleep latency were calculated using 20-minute censored MWT data and compared to 40-minute MWT data. Results In Study 201, mean (standard deviation) changes in MWT sleep latency were 12.7 (10.6) minutes with JZP-110 versus 0.9 (6.0) minutes with placebo ( P =0.0002) for 40-minute data, and 8.9 (6.3) versus 0.4 (4.6) minutes for 20-minute censored data ( P <0.0001). In Study 202, mean changes in MWT sleep latency were 12.8 (10.3) minutes with JZP-110 versus 2.1 (7.9) minutes with placebo ( P <0.0001) for 40-minute data, and 8.9 (5.5) versus 1.1 (5.6) minutes for 20-minute censored data ( P <0.0001). In Studies 201 and 202, respectively, Cohen’s d effect sizes were large and numerically greater for 20-minute censored data (1.54 and 1.41) versus 40-minute data (1.37 and 1.17). Conclusions In patients with narcolepsy, JZP-110 significantly improved the ability to stay awake compared with placebo, with large effect sizes using both the 40-minute and 20-minute censored MWT data.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>28619176</pmid><doi>10.1016/j.sleep.2017.03.025</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Carbamates - adverse effects Carbamates - therapeutic use Cross-Over Studies Female Humans JZP-110 Maintenance of Wakefulness Test Male Narcolepsy Narcolepsy - diagnosis Narcolepsy - drug therapy Neurology Phenylalanine - adverse effects Phenylalanine - analogs & derivatives Phenylalanine - therapeutic use Sleep - drug effects Sleep latency Sleep Medicine Time Factors Treatment Outcome Wakefulness Wakefulness - drug effects Wakefulness-Promoting Agents - adverse effects Wakefulness-Promoting Agents - therapeutic use |
| title | Evaluation of the Effect of JZP-110 in Patients with Narcolepsy Assessed Using the Maintenance of Wakefulness Test Censored to 20 Minutes |
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