Author Contributions: Dr Brandes, as principal investigator, had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Brandes, Adelman, Spruill, Barrett, Lener.
Acquisition of data: Brandes, Kudrow, Stark, O’Carroll, Adelman, O’Donnell, Spruill.
Analysis and interpretation of data: Brandes, Kudrow, Stark, O’Carroll, Adelman, O’Donnell, Alexander, Spruill, Barrett, Lener.
Drafting of the manuscript: Brandes, Kudrow, Stark, O’Donnell, Spruill.
Critical revision of the manuscript for important intellectual content: Brandes, Kudrow, Stark, O’Carroll, Adelman, O’Donnell, Alexander, Spruill, Barrett, Lener.
Statistical analysis: Spruill.
Obtained funding: Barrett, Lener.
Administrative, technical, or material support: Brandes, Kudrow.
Study supervision: Brandes, Adelman, Alexander, Barrett, Lener.
Financial Disclosures: Dr Brandes reports having received clinical research or educational support from Merck, GlaxoSmithKline, UCB Pharma, Allergan, Johnson & Johnson, AstraZeneca, Pfizer, Bristol-Myers Squibb, Winston Laboratories, Sanofi-Aventis, Elan Pharmaceuticals, Novartis, Endo, POZEN, Vernalis, Ortho-McNeil, Advanced Bionics, Forest Laboratories, MedPointe Pharmaceuticals, and Aradigm Corp. Dr Kudrow reports having received research grants from Ortho-McNeil, Pfizer, GlaxoSmithKline, Merck, and Eisai and has served on the speaker's bureau for Pfizer and GlaxoSmithKline. Dr Stark reports having received clinical research or educational support from GlaxoSmithKline, Proethics, Allergan, Ortho-McNeil, Pfizer, and Merck. Dr O’Carroll reports having received clinical research or educational support from Allergan, GlaxoSmithKline, Merck, Pfizer, Eli Lilly, Sanofi-Aventis, Cephalon, Forest Pharmaceutical, AstraZeneca, Ortho-McNeil, POZEN, and Ligand Pharmaceuticals. Dr Adelman reports having received clinical research support from GlaxoSmithKline and POZEN and having served on advisory boards or speaker's bureaus for GlaxoSmithKline, AstraZeneca, Pfizer, Merck, and Ortho-McNeil. Dr O’Donnell reports having received research support from Merck, GlaxoSmithKline, and Allergan; having served as a consultant for Merck, GlaxoSmithKline, and Ortho-McNeil; and having received speaker's honoraria from Merck, GlaxoSmithKline, Pfizer, and Ortho-McNeil. Dr Alexander is a previous employee and shareholder of POZEN. Ms Spruill is a previous employee of and currently serves as a consultant to POZEN. Ms Barrett is a previous employee of GlaxoSmithKline, serves as a consultant to GlaxoSmithKline, and is a stockholder in Pfizer. Ms Lener is an employee of GlaxoSmithKline.
MT400-301 Study Group:Alabama:Birmingham: Gregory M. Flippo, MD; Radiant Research, Birmingham, Gordon T. Connor, MD; Montgomery: Drug Research and Analysis Corp, Norman A. Garrison, Jr, MD; Arizona:Tucson: Northwest NeuroSpecialists PLLC, Jeanette Wendt; Arkansas:Hot Springs: Palmetto Clinical Research, Richard G. Pellegrino, MD; Little Rock: Clinical Study Centers LLC, Gordon L. Gibson, MD; California:San Diego: Medical Center for Clinical Research, William D. Koltun, MD; Santa Monica: California Medical Clinic for Headache, David Kudrow, MD; Oceanside: The Neurology Center, Benjamin M. Frishberg, MD; Walnut Creek: Neurological Research Institute of the East Bay, Michael Stein, MD; Florida:Hialeah: Medical Research Unlimited, Steven D. Wheeler, MD; Melbourne: Comprehensive Neuroscience Inc, Murray A. Kimmel, DO; Miami: Miami Research Associates Inc, Bruce Kohrman, MD; Palm Beach Gardens: Palm Beach Neurological Center, Michael M. Tuchman, MD; Plantation: Neurology Clinical Research Inc, Richard P. Singer, MD; Port Orange: Coastal Medical Research, Alex White, MD; West Palm Beach: Premiere Research Institute, Paul K. Winner, DO; Georgia:Augusta: Walton Headache Center, Marc Husid; Decatur: Neurology and Headache Specialists of Atlanta, Sarah E. DeRossett; Illinois:Chicago: Diamond Headache Clinic, Merle Lea Diamond, MD; Indiana:Evansville: MediSphere Medical Research Center LLC, Steven K. Elliott, MD; Research Solutions, Jennifer S. Wahle, MD; Indianapolis: Midwest Institute for Clinical Research, Phillip D. Toth, MD; Louisiana:Lake Charles: The Clinic, Alan Sconzert, MD, PhD; Metairie: New Orleans Medical Institute, Robert B. De Trinis, MD; Massachusetts:Milford: Milford Emergency Associates Inc, Anthony Puopolo, MD; North Dartmouth: Northeast Medical Research Associates Inc, S. David Miller, MD; Worcester: New England Regional Headache Center, Herbert G. Markley, MD; Michigan:Ann Arbor: Michigan Head-Pain and Neurological Institute, Todd Rozen, MD; Kalamazoo: Westside Family Medical Center, Gary Ruoff, MD; Missouri:St. Louis: Mercy Health Research, Timothy R. Smith, MD; Radiant Research Inc, Mohammed Z. Abudalu, MD; Nevada:Las Vegas: Lovelace Scientific Resources, James Snyder, MD; New Mexico:Albuquerque: Lovelace Scientific Resources, Lydia Lawson, MD; New York:Endwell: Regional Clinical Research Inc, Victor A. Elinoff, MD; New York City: Analgesic Development Ltd, Abraham Sunshine, MD; New York Headache Center, Alexander Mauskop, MD; North Carolina:Charlotte: Charlotte Clinical Research Inc, Greg V. Collins, MD; Greensboro: Headache Wellness Center, James U. Adelman, MD; Raleigh: Multi-Specialty Research Associates of North Carolina, John Rubino, MD; Ohio:Cincinnati: Community Research, Bruce C. Corser, MD; Radiant Research Inc, Michael J. Noss, MD; Oklahoma:Tulsa: Neurological Associates of Tulsa Inc, Harvey J. Blumenthal, MD, James Dean, MD; Oregon:Portland: Radiant Research Inc, Keith D. Klatt, MD; The Neurology Clinic, Hubert A. Leonard, MD, PhD; Pennsylvania:Lancaster: Oyster Point Family Health Center Research Across America, Michael Warren, MD; Philadelphia: Jefferson Headache Center, Stephen D. Silberstein, MD; Rhode Island:Warwick: Omega Medical Research, David L. Fried, MD; South Carolina:Mt Pleasant: Coastal Carolina Research Center, Cynthia Strout, MD; Summerville: Palmetto Clinical Research, Michael Otruba, DO; Tennessee:Nashville: Nashville Neuroscience Group PC, Jan Lewis Brandes, MD; Texas:Austin: Benchmark Research Austin, Teresa L. Coats, MD; Fort Worth: Benchmark Research, William Seger, MD; San Angelo: West Texas Medical Associates, Darrell T. Herrington, DO; San Antonio: Integra Clinical Research LLC, Susanne K. Gazda, MD; Radiant Research, San Antonio, William P. Jennings, MD; Richardson: KRK Medical Research, Roy S. Kiser, MD; Virginia:Roanoke: Blue Ridge Research Center, Gordon Burch, MD; Wisconsin:Milwaukee: Advanced Healthcare SC, Daniel J. Thompson, MD.
MT400-302 Study Group:Alabama:Huntsville: AmDoc Inc, Medical Affiliated Research Center Inc, Harry Lee McDaris, M.D; Mobile: USA Neurology, John F. Rothrock, MD; Arizona:Phoenix: Lovelace Scientific Resources Inc, Philip B. James, MD, Richard V. Albery, MD; Valley Neurological Headache Clinic, Carol Foster, MD; Scottsdale: Radiant Research-Scottsdale, Timm McCarty, MD; Tucson: Radiant Research-Tucson, Frank Dunlap, MD, Robert Hirsch, MD; Arkansas:Little Rock: Little Rock Family Practice Clinic, Kevin Roberts, MD; California:Carlsbad: Sanjeev Sharma, MD; Irvine: Radiant Research-Irvine, Sid Rosenblatt, MD; Newport Beach: Christopher Philip O’Carroll, MD; Northridge: Northridge Neurological Center; Ronald B. Ziman, MD; Redondo Beach: George J. Rederich, MD, PhD; Colorado:Denver: Radiant Research Inc, Leslie Moldauer, MD; Connecticut:Stamford: The New England Center for Headache, Alan M. Rapoport, MD; Stratford: Clinical Research Consultants Inc, Selwyn A. Cohen, MD; Florida:Clearwater: Tampa Bay Medical Research Inc, Steven C. Bowman, MD; Coral Gables: Clinical Research of South Florida, Jeffrey B. Rosen, MD; Ft Myers: Internal Medicine Associates-Department of Research, Stephen R. Zellner, MD; Gainesville: Florida Medical Research Institute PA, C. Richard King, MD; St Petersburg: Comprehensive NeuroScience Inc, Margarita Nunez, MD; Meridian Research, Mildred (Mimi) Farmer, MD; Georgia:Atlanta: Child Neurology Associates LLC, Frank Berenson, MD; Illinois:Peoria: NTouch Research, Daniel Brune, MD; Maryland:Towson: International Research Center, Alberto Yataco, MD; Minnesota:Plymouth: Clinical Research Institute, Gary Berman, MD; Missouri:Kansas City: The Center for Pharmaceutical Research, John Ervin, MD; Springfield: Headache Care Center, Roger Cady, MD; New Hampshire:Lebanon: Neurology Studies Group, Dartmouth-Hitchcock Medical Center, Thomas N. Ward, MD; New Jersey:Morristown: Neuroscience Center of Northern New Jersey, Stuart W. Fox, MD; Princeton: Global Medical Institute, Jeffrey Apter, MD; Ridgewood: Neurology Group of Bergen County, PA, Kenneth A. Levin, MD; New York:Albany: Upstate Clinical Research, James P. Wymer, MD; Manlius: Central New York Clinical Research, Douglas P. Zmolek, MD; North Carolina:Raleigh: North Carolina Clinical Research, Craig F. LaForce, MD; Winston-Salem: Piedmont Medical Research Associates, Thomas Littlejohn, MD; Ohio:Cleveland: Health Research Associates, Robert S. Kunkel, MD; Columbus: Columbus Neurological Group Inc, Kenneth A. Mankowski, MD; Radiant Research Inc, Douglas Schumacher, MD; Mogadore: Radiant Research Inc, Dennis C. McCluskey, MD; Toledo: Headache Center of Ohio, Gary Gerard, MD; West Chester: ClinExcel Research, Lisa K. Mannix, MD; Westerville: Ortho Neuro Inc, Francis O’Donnell, DO; Pennsylvania:Philadelphia: Radiant Research-Einstein Center One, Barry Packman, MD; South Carolina:Anderson: Radiant Research Inc, Harry I. Geisberg, MD; Greer: Radiant Research-Greer, William Travis Ellison, MD; Statesville: Statesville Research Institute, Neil M. Kassman, MD; Tennessee:Memphis: Wesley Headache Clinic, Stephen H. Landy, MD; Nashville: Clinical Research Associates Inc, Stephen C. Sharp, MD; Texas:Dallas: Harold Urschel, MD; Houston: The Houston Headache Clinic, Ninan T. Mathew, MD; Lubbock: Bhupesh Dihenia, MD; San Antonio: Texas Association of Pediatric Neurology PA, Jerry Tomasovic, MD; Utah:Salt Lake City: Jean Brown Research-JBA Research Inc, Gilbert Podolsky, MD; Vermont:Burlington: Department of Neurology, College of Medicine, University of Vermont, Robert Shapiro, MD; Virginia:Alexandria: The Innovative Clinical Research Center, Stuart R. Stark, MD; Washington:Spokane: Rockwood Research Department, Timothy W. Powell, MD, Steven Pugh, MD; Tacoma: Neurology and Neurosurgery Associates of Tacoma, John Huddlestone, MD; Wenatchee: Clinical Research-Wenatchee Valley Medical Center, James R. Cook, MD.
Funding/Support: The 2 clinical trials (MT-400:301 and MT-400:302) described in this article were funded by GlaxoSmithKline in partnership with POZEN, the IND sponsor of the investigational drug MT-400 (sumatriptan–naproxen sodium).
Role of the Sponsors: GlaxoSmithKline and Pozen Inc provided financial and material support, monitoring, data collection and management, and data analysis to the authors and study investigators.
Independent Statistical Analysis: Eugene Laska, PhD (director, Statistical Sciences Laboratory, Nathan S. Kline Institute for Psychiatric Research, and professor, Department of Psychiatry, New York University School of Medicine, Orangeburg), had full access to all of the efficacy data and was provided the SAS programs and statistical output produced by POZEN/GlaxoSmithKline. Dr Laska reviewed the appropriateness of the analytic approach to the analysis of the primary efficacy measures and select secondary outcomes, suggested additional analyses, and verified the primary results reported in the article. POZEN/GlaxoSmithKline Pharmaceutical Research and Development paid Dr Laska for the time he spent on the review. Research assistance was provided to Dr Laska by Joseph Wanderling, a research scientist at the Nathan S. Kline Institute for Psychiatric Research.
Acknowledgment: We acknowledge Meredith A. Cucuel, BA, of Nashville Neuroscience Group, Nashville, Tenn, for editorial assistance, Michael H. Ames, PhD, of GlaxoSmithKline, Research Triangle Park, NC, for statistical input, Jane Saiers, PhD, of The WriteMedicine Inc, Chapel Hill, NC, for assistance with preparation of the manuscript, and Susan A. McDonald, MA, of GlaxoSmithKline, Research Triangle Park, NC, for critical review of the manuscript. Ms Cucuel's work on the manuscript was funded by Nashville Neuroscience Group and Dr Saiers' work on the manuscript was funded by GlaxoSmithKline.