2012
Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis
Shefner J, Cedarbaum JM, Cudkowicz ME, Maragakis N, Lee J, Jones D, Watson ML, Mahoney K, Chen M, Saikali K, Mao J, Russell AJ, Hansen RL, Malik F, Wolff AA, Team F. Safety, tolerability and pharmacodynamics of a skeletal muscle activator in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis And Frontotemporal Degeneration 2012, 13: 430-438. PMID: 22591195, DOI: 10.3109/17482968.2012.684214.Peer-Reviewed Original ResearchConceptsAmyotrophic lateral sclerosisSingle dosesGlobal ImpressionLateral sclerosisFast skeletal muscle troponin activatorFrequent adverse eventsDose-related fashionLimb muscle strengthMaximum voluntary ventilationDose-dependent benefitMeasures of enduranceAdverse eventsPulmonary functionVoluntary ventilationGeneral fatigueTroponin activatorMuscle strengthPharmacodynamic markersHandgrip endurancePatientsRandom orderMaximal strengthDosesTolerabilityFurther studiesA Study To Evaluate Safety, and Tolerability of Repeated Doses of CK-2017357 (CK-357) in Patients with Amyotrophic Lateral Sclerosis (S25.005)
Shefner J, Barohn R, Boylan K, Bradshaw D, Brooks B, Heiman-Patterson T, Katz J, Maragakis N, Mitsumoto H, Pestronk A, Simmons Z, Wolff A, Lee J, Masonek J, Jones D, Meng L, Cedarbaum J. A Study To Evaluate Safety, and Tolerability of Repeated Doses of CK-2017357 (CK-357) in Patients with Amyotrophic Lateral Sclerosis (S25.005). Neurology 2012, 78: s25.005-s25.005. DOI: 10.1212/wnl.78.1_meetingabstracts.s25.005.Peer-Reviewed Original ResearchA Study To Evaluate Safety and Tolerability of CK-2017357 (CK-357) in Patients with Amyotrophic Lateral Sclerosis Using a Twice-Daily, Dose-Titration Regimen (P04.155)
Shefner J, Andrews J, Bedlack R, Berry J, Goslin K, Jackson C, Kissel J, Lange D, Licht J, Mozaffar T, Pestronk A, Rosenfeld J, Wolff A, Lee J, Masonek J, Jones D, Meng L, Cedarbaum J. A Study To Evaluate Safety and Tolerability of CK-2017357 (CK-357) in Patients with Amyotrophic Lateral Sclerosis Using a Twice-Daily, Dose-Titration Regimen (P04.155). Neurology 2012, 78: p04.155-p04.155. DOI: 10.1212/wnl.78.1_meetingabstracts.p04.155.Peer-Reviewed Original Research
2011
P2‐476: A Phase 1, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral daily doses of ELND006 in healthy elderly subjects
Liang E, Liu W, Lohr L, Nguyen V, Lin H, Munson M, Crans G, Cedarbaum J. P2‐476: A Phase 1, dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral daily doses of ELND006 in healthy elderly subjects. Alzheimer's & Dementia 2011, 7: s465-s465. DOI: 10.1016/j.jalz.2011.05.1347.Peer-Reviewed Original Research