Search Results - "VERSAVEL, Mark"

Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of Vixotrigine in Healthy Volunteers by Naik, Himanshu, Steiner, Deb J., Versavel, Mark, Palmer, Joanne, Fong, Regan

“…Neuropathic pain affects ~ 6.9–10% of the general population and leads to loss of function, anxiety, depression, sleep disturbance, and impaired cognition…”
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Efficacy and tolerability of twice-daily pregabalin for treating pain and related sleep interference in postherpetic neuralgia: a 13‐week, randomized trial by van Seventer, Robert, Feister, Hilary A., Young, James P., Stoker, Malcolm, Versavel, Mark, Rigaudy, Laurence

“…ABSTRACT Objective: This trial evaluated the efficacy and safety of pregabalin dosed twice daily (BID) for relief of neuro-pathic pain associated with…”
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Phase 1 study to evaluate the absorption, metabolism and excretion of the NAV1.7-selective sodium channel blocker BIIB074 by Woodward, Caroline, Naik, Himanshu, Versavel, Mark, Xu, Lin, Miao, Xiaopeng, Sun, Hao, Gohdes, Mark, Dunbar, Joi

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Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations by Edwards, Robert R., Dworkin, Robert H., Turk, Dennis C., Angst, Martin S., Dionne, Raymond, Freeman, Roy, Hansson, Per, Haroutounian, Simon, Arendt-Nielsen, Lars, Attal, Nadine, Baron, Ralf, Brell, Joanna, Bujanover, Shay, Burke, Laurie B., Carr, Daniel, Chappell, Amy S., Cowan, Penney, Etropolski, Mila, Fillingim, Roger B., Gewandter, Jennifer S., Katz, Nathaniel P., Kopecky, Ernest A., Markman, John D., Nomikos, George, Porter, Linda, Rappaport, Bob A., Rice, Andrew S.C., Scavone, Joseph M., Scholz, Joachim, Simon, Lee S., Smith, Shannon M., Tobias, Jeffrey, Tockarshewsky, Tina, Veasley, Christine, Versavel, Mark, Wasan, Ajay D., Wen, Warren, Yarnitsky, David

“…There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great…”
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Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease by Hey, John A., Yu, Jeremy Y., Versavel, Mark, Abushakra, Susan, Kocis, Petr, Power, Aidan, Kaplan, Paul L., Amedio, John, Tolar, Martin

“…Background ALZ-801 is an orally available, valine-conjugated prodrug of tramiprosate. Tramiprosate, the active agent, is a small-molecule β-amyloid (Aβ)…”
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A Phase 2a Study of CX-8998, an Oral, Potent and Selective T-Type Calcium Modulator in Adolescents and Young Adults with Absence Epilepsy: Rationale for population and dose selection (P5.282) by Papapetropoulos, Spiridon, Lee, Margaret, Boyer, Stacey, Versavel, Mark

“…Abstract only…”
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A Phase 2 Proof‐of‐Concept, Randomized, Placebo‐Controlled Trial of CX‐8998 in Essential Tremor by Papapetropoulos, Spyros, Lee, Margaret S., Versavel, Stacey, Newbold, Evan, Jinnah, Hyder A., Pahwa, Rajesh, Lyons, Kelly E., Elble, Rodger, Ondo, William, Zesiewicz, Theresa, Hedera, Peter, Handforth, Adrian, Elder, Jenna, Versavel, Mark

“…Background Available essential tremor (ET) therapies have limitations. Objectives The objective of this study was to evaluate CX‐8998, a selective T‐type…”
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Patient phenotyping in clinical trials of chronic pain treatments: IMMPACT recommendations by Edwards, Robert R., Dworkin, Robert H., Turk, Dennis C., Angst, Martin S., Dionne, Raymond, Freeman, Roy, Hansson, Per, Haroutounian, Simon, Arendt-Nielsen, Lars, Attal, Nadine, Baron, Ralf, Brell, Joanna, Bujanover, Shay, Burke, Laurie B., Carr, Daniel, Chappell, Amy S., Cowan, Penney, Etropolski, Mila, Fillingim, Roger B., Gewandter, Jennifer S., Katz, Nathaniel P., Kopecky, Ernest A., Markman, John D., Nomikos, George, Porter, Linda, Rappaport, Bob A., Rice, Andrew S.C., Scavone, Joseph M., Scholz, Joachim, Simon, Lee S., Smith, Shannon M., Tobias, Jeffrey, Tockarshewsky, Tina, Veasley, Christine, Versavel, Mark, Wasan, Ajay D., Wen, Warren, Yarnitsky, David

“…There is tremendous interpatient variability in the response to analgesic therapy (even for efficacious treatments), which can be the source of great…”
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Ziprasidone Plus a Mood Stabilizer in Subjects With Bipolar I Disorder: A 6-Month, Randomized, Placebo-Controlled, Double-Blind Trial by BOWDEN, Charles L, VIETA, Eduard, ICE, Kathleen S, SCHWARTZ, Jeffrey H, WANG, Paul P, VERSAVEL, Mark

“…To evaluate the efficacy and safety of ziprasidone adjunctive to a mood stabilizer for the maintenance treatment of bipolar mania. Subjects with DSM-IV bipolar…”
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Evaluation of the Potential Pharmacokinetic Interactions Between Vixotrigine and an Oral Contraceptive by Zhao, Yuan, Versavel, Mark, Tidemann-Miller, Beth, Christmann, Romy, Naik, Himanshu

“…Background and Objective Vixotrigine is a voltage- and use-dependent sodium channel blocker in development for neuropathic pain management. This study…”
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Efficacy and Safety of CX-8998 in T-CALM, a Randomized, Double-Blind, Placebo-Controlled, Phase 2a Trial in Participants With Essential Tremor: Subgroup Analysis by Baseline Tremor Severity (1842) by Jinnah, Hyder A., Papapetropoulos, Spyros, Lee, Margaret, Boyer, Stacey, Newbold, Evan, Pahwa, Rajesh, Lyons, Kelly E., Elble, Rodger, Ondo, William, Zesiewicz, Theresa, Hedera, Peter, Handforth, Adrian, Elder, Jenna, Versavel, Mark

“…Abstract only…”
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Pregabalin for relief of neuropathic pain associated with diabetic neuropathy: A randomized, double-blind study by Tölle, Thomas, Freynhagen, Rainer, Versavel, Mark, Trostmann, Uwe, Young, James P

“…Abstract Seven published, randomized, placebo-controlled clinical trials with pregabalin have shown robust efficacy for relief of neuropathic pain from DPN and…”
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Pregabalin reduces pain and improves sleep and mood disturbances in patients with post-herpetic neuralgia: results of a randomised, placebo-controlled clinical trial by Sabatowski, Rainer, Gálvez, Rafael, Cherry, David A, Jacquot, Florence, Vincent, Emmanuelle, Maisonobe, Pascal, Versavel, Mark, The 1008-045 Study Group

“…This study was designed to assess the efficacy and safety of pregabalin—a novel α 2-δ ligand with analgesic, anxiolytic, and anticonvulsant activity—for…”
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Pain intensity rating training: results from an exploratory study of the ACTTION PROTECCT system by Smith, Shannon M., Amtmann, Dagmar, Askew, Robert L., Gewandter, Jennifer S., Hunsinger, Matthew, Jensen, Mark P., McDermott, Michael P., Patel, Kushang V., Williams, Mark, Bacci, Elizabeth D., Burke, Laurie B., Chambers, Christine T., Cooper, Stephen A., Cowan, Penney, Desjardins, Paul, Etropolski, Mila, Farrar, John T., Gilron, Ian, Huang, I-zu, Katz, Mitchell, Kerns, Robert D., Kopecky, Ernest A., Rappaport, Bob A., Resnick, Malca, Strand, Vibeke, Vanhove, Geertrui F., Veasley, Christin, Versavel, Mark, Wasan, Ajay D., Turk, Dennis C., Dworkin, Robert H.

“…Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes…”
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P2‐012: Phase 1 Development of ALZ‐801, a Novel Beta Amyloid Anti‐Aggregation Prodrug of Tramiprosate with Improved Drug Properties, Supporting Bridging to The Phase 3 Program by Hey, John, Abushakra, Susan, Power, Aidan, Yu, Jeremy, Versavel, Mark, Tolar, Martin

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PHASE 1 DEVELOPMENT OF ALZ-801, A NOVEL BETA AMYLOID ANTI-AGGREGATION PRODRUG OF TRAMIPROSATE WITH IMPROVED DRUG PROPERTIES, SUPPORTING BRIDGING TO THE PHASE 3 PROGRAM by Hey, John, Abushakra, Susan, Power, Aidan, Yu, Jeremy, Versavel, Mark, Tolar, Martin

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Tolerability of oral ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder by DelBello, Melissa P, Versavel, Mark, Ice, Kathleen, Keller, David, Miceli, Jeffrey

“…This study characterizes the tolerability of ziprasidone in children and adolescents with bipolar mania, schizophrenia, or schizoaffective disorder…”
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Evaluation of the Pharmacokinetic Interaction Between the Voltage‐ and Use‐Dependent Nav1.7 Channel Blocker Vixotrigine and Carbamazepine in Healthy Volunteers by Dunbar, Joi, Versavel, Mark, Zhao, Yuan, Tate, Simon, Morisset, Valerie, Giblin, Gerard M. P., Palmer, Joanne, Tidemann‐Miller, Beth, Naik, Himanshu

“…Vixotrigine is a voltage‐ and use‐dependent Nav1.7 channel blocker under investigation for the treatment of peripheral neuropathic pain conditions, including…”
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The impact of calories and fat content of meals on oral ziprasidone absorption: a randomized, open-label, crossover trial by Gandelman, Kuan, Alderman, Jeffrey A, Glue, Paul, Lombardo, Ilise, LaBadie, Robert R, Versavel, Mark, Preskorn, Sheldon H

“…Food is known to increase the bioavailability of ziprasidone. Therefore, we evaluated the effects of meals of differing caloric and fat content on steady-state…”
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Inclusion and exclusion criteria for epilepsy clinical trials–Recommendations from the April 30, 2011 NINDS workshop by Fertig, Evan, Fureman, Brandy E, Bergey, Gregory K, Brodie, Mary Ann, Hesdorffer, Dale C, Hirtz, Deborah, Kossoff, Eric H, LaFrance, W. Curt, Versavel, Mark, French, Jacqueline

“…Highlights • Adequate selection and enrollment of subjects are key to successful epilepsy trials. • Selection criteria must maximize scientific impact, safety,…”
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