Search Results - "Forrestal, Fiona"

Long-term safety and effectiveness of natalizumab redosing and treatment in the STRATA MS Study by OʼConnor, Paul, Goodman, Andrew, Kappos, Ludwig, Lublin, Fred, Polman, Chris, Rudick, Richard A, Hauswirth, Kathy, Cristiano, Lynda M, Forrestal, Fiona, Duda, Petra

“…OBJECTIVES:Report long-term safety and effectiveness of natalizumab over 240 weeks in the prospective, observational, open-label Safety of TYSABRI Re-dosing…”
Get full text

Assessment of JC virus DNA in blood and urine from natalizumab-treated patients by Rudick, Richard A., O'Connor, Paul W., Polman, Chris H., Goodman, Andrew D., Ray, Soma S., Griffith, Nancy M., Jurgensen, Stephanie A., Gorelik, Leonid, Forrestal, Fiona, Sandrock, Alfred W., E. Goelz, Susan

“…Objective Analyses were conducted to determine the clinical utility of measuring JC virus (JCV) DNA in blood or urine of natalizumab‐treated multiple sclerosis…”
Get full text

Amyloid-Related Imaging Abnormalities in 2 Phase 3 Studies Evaluating Aducanumab in Patients With Early Alzheimer Disease by Salloway, Stephen, Chalkias, Spyros, Barkhof, Frederik, Burkett, Patrick, Barakos, Jerome, Purcell, Derk, Suhy, Joyce, Forrestal, Fiona, Tian, Ying, Umans, Kimberly, Wang, Guanfang, Singhal, Priya, Budd Haeberlein, Samantha, Smirnakis, Karen

“…The EMERGE and ENGAGE phase 3 randomized clinical trials of aducanumab provide a robust data set to characterize amyloid-related imaging abnormalities (ARIA)…”
Get more information

Zuranolone for the Treatment of Postpartum Depression by Deligiannidis, Kristina M, Meltzer-Brody, Samantha, Maximos, Bassem, Peeper, E Quinn, Freeman, Marlene, Lasser, Robert, Bullock, Amy, Kotecha, Mona, Li, Sigui, Forrestal, Fiona, Rana, Nilanjana, Garcia, Manny, Leclair, Bridgette, Doherty, James

“…Postpartum depression (PPD) is a common perinatal complication with adverse maternal and infant outcomes. This study investigated the efficacy and safety of…”
Get full text

Zuranolone for the Treatment of Adults With Major Depressive Disorder: A Randomized, Placebo-Controlled Phase 3 Trial by Clayton, Anita H, Lasser, Robert, Parikh, Sagar V, Iosifescu, Dan V, Jung, JungAh, Kotecha, Mona, Forrestal, Fiona, Jonas, Jeffrey, Kanes, Stephen J, Doherty, James

“…This study assessed the efficacy and safety of a 14-day treatment course of once-daily zuranolone 50 mg, an investigational oral positive allosteric modulator…”
Get full text

Natalizumab treatment shows no clinically meaningful effects on immunization responses in patients with relapsing-remitting multiple sclerosis by Kaufman, Michael, Pardo, Gabriel, Rossman, Howard, Sweetser, Marianne T, Forrestal, Fiona, Duda, Petra

“…Abstract Natalizumab is an immunomodulatory drug approved for the treatment of multiple sclerosis. This randomized, multicenter, open-label study evaluated…”
Get full text

Effect of zuranolone on insomnia symptoms in patients with postpartum depression in the SKYLARK study by Maximos, Bassem, Deligiannidis, Kristina, Meltzer-Brody, Samantha, Peeper, E. Quinn, Lasser, Robert, Bullock, Amy, Kotecha, Mona, Sigui li, Forrestal, Fiona, Garcia, Manny, Leclair, Bridgette, Doherty, Jim

Get full text

Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study by Parikh, Sagar V, Aaronson, Scott T, Mathew, Sanjay J, Alva, Gustavo, DeBattista, Charles, Kanes, Stephen, Lasser, Robert, Bullock, Amy, Kotecha, Mona, Jung, JungAh, Forrestal, Fiona, Jonas, Jeff, Vera, Theresa, Leclair, Bridgette, Doherty, James

“…Major depressive disorder (MDD) is a mental health disorder that can cause disability and functional impairment that standard-of-care (SOC) antidepressant…”
Get full text

Item-Level Analysis of Clinical Measures in Patients With Early Symptomatic Alzheimer’s Disease Following Treatment With High-Dose Aducanumab in the Phase 3 EMERGE Study (P1-1.Virtual) by Cohen, Sharon, He, Ping, Benea, Mihaela Levitchi, Miller, Ryan, Forrestal, Fiona, Pang, Menglan, Castrillo-Viguera, Carmen, Jaeger, Judith, Mummery, Catherine, Porsteinsson, Anton, Cummings, Jeffrey, Tian, Ying, Yang, Lili, Haeberlein, Samantha Budd

“…Abstract only…”
Get full text

Long-Term Safety and Efficacy of Initial and Repeat Treatment Courses With Zuranolone in Adult Patients With Major Depressive Disorder: Interim Results From the Open-Label, Phase 3 SHORELINE Study by Cutler, Andrew J, Mattingly, Gregory W, Kornstein, Susan G, Aaronson, Scott T, Lasser, Robert, Zhang, Hongling, Rana, Nilanjana, Brown, Colville, Levin, Seth, Miller, Catherine, Kotecha, Mona, Forrestal, Fiona, Doherty, James

“…Zuranolone is a positive allosteric modulator of both synaptic and extrasynaptic γ-aminobutyric acid (GABA) type A receptors and a neuroactive steroid approved…”
Get full text

Population Pharmacokinetics of Vixotrigine in Healthy Volunteers and Subjects with Trigeminal Neuralgia, Painful Lumbosacral Radiculopathy and Erythromelalgia by Naik, Himanshu, Zhao, Yuan, Forrestal, Fiona, Cleall, Simon, Bockbrader, Howard, Chapel, Sunny

“…Background Vixotrigine is a voltage and use dependent sodium channel blocker currently under development for treatment of various neuropathic pain indications…”
Get full text

CONVEY, A Phase 2 Placebo-Controlled, Double-Blind, Enriched Enrollment Randomized Withdrawal Study Design of Vixotrigine for the Treatment of Pain in Participants With Confirmed Small Fiber Neuropathy (P2.6-068) by Shinobu, Leslie, Polydefkis, Michael, Lauria, Giuseppe, Faber, Catharina, Freeman, Roy, Steiner, Deborah, Naik, Himanshu, Forrestal, Fiona, Bolsover, Nikki, Dawson, Katherine

“…Abstract only…”
Get full text

Predicted Lifetime Health Outcomes for Aducanumab in Patients with Early Alzheimer’s Disease by Herring, William L., Gould, Ian Gopal, Fillit, Howard, Lindgren, Peter, Forrestal, Fiona, Thompson, Robin, Pemberton-Ross, Peter

“…Introduction Alzheimer’s disease (AD) is a chronic and progressive neurodegenerative disease that places a substantial burden on patients and caregivers…”
Get full text

Item‐level analysis of clinical measures in patients with early symptomatic Alzheimer’s disease following treatment with high‐dose aducanumab in the phase 3 study EMERGE by Cohen, Sharon, He, Ping, Benea, Mihaela Levitchi, Miller, Ryan, Forrestal, Fiona, Pang, Menglan, Castrillo‐Viguera, Carmen, Harrison, John E, Jaeger, Judy, Mummery, Catherine J., Porsteinsson, Anton P., Cummings, Jeffrey L., Tian, Ying, Yang, Lili, Haeberlein, Samantha Budd

“…Background EMERGE (NCT02484547), 1 of 2 Phase 3 trials evaluating aducanumab in patients with early Alzheimer’s disease (AD), demonstrated a statistically…”
Get full text

Do MRI Lesions Predict MS Relapses? (P3.190) by Richert, Nancy, Forrestal, Fiona, Lee, Sophia, Duda, Petra

“…Abstract only…”
Get full text

Disability Progression in Multiple Sclerosis Patients Treated with Natalizumab in the Long-term STRATA Study (P3.163) by Goodman, Andrew, Kappos, Ludwig, Lublin, Fred, Belachew, Shibeshih, Chirieac, Madalina, Forrestal, Fiona, Duda, Petra

“…Abstract only…”
Get full text