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 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
1991
Reduction of Circulating 3-O-Methyldopa by Inhibition of Gatechol-O-Methyltransferase With OR-611 and OR-462 in Cynomolgus Monkeys: Implications for the Treatment of Parkinson's Disease.
Cedarbaum J, Leger G, Guttman M. Reduction of Circulating 3-O-Methyldopa by Inhibition of Gatechol-O-Methyltransferase With OR-611 and OR-462 in Cynomolgus Monkeys: Implications for the Treatment of Parkinson's Disease. Clinical Neuropharmacology 1991, 14: 330. PMID: 1913700, DOI: 10.1097/00002826-199108000-00005.Peer-Reviewed Original Research
1988
Controlled-Release Levodopa/Carbidopa III: Sinemet CR5 Treatment of Response Fluctuations in Parkinson's Disease.
Cedarbaum JM, Hoey M, Kutt H, McDowell FH. Controlled-Release Levodopa/Carbidopa III: Sinemet CR5 Treatment of Response Fluctuations in Parkinson's Disease. Clinical Neuropharmacology 1988, 11: 168. PMID: 3378225, DOI: 10.1097/00002826-198804000-00008.Peer-Reviewed Original ResearchConceptsSinemet CR4Parkinson's diseasePeak plasma levodopa concentrationResponse fluctuationsOpen-label studyAdvanced Parkinson's diseasePlasma levodopa concentrationsStandard SinemetInterdose intervalDaily dosesTherapeutic responseLevodopa concentrationsSame patientLabel studyDiseaseRelative bioavailabilityPatientsGreater delayTreatmentSinemetLevodopaDoses
1987
Controlled-release levodopa/carbidopa. II. Sinemet CR4 treatment of response fluctuations in Parkinson's disease.
Cedarbaum J, Breck L, Kutt H, McDowell F. Controlled-release levodopa/carbidopa. II. Sinemet CR4 treatment of response fluctuations in Parkinson's disease. Neurology 1987, 37: 1607-12. PMID: 3658164, DOI: 10.1212/wnl.37.10.1607-a.Peer-Reviewed Original ResearchConceptsSinemet CR4Interdose intervalParkinson's diseaseResponse fluctuationsTherapeutic response fluctuationsOpen-label trialPlasma levodopa levelsSlow-release preparationAntiparkinsonian effectsStandard levodopaLevodopa dosesLevodopa preparationsLevodopa levelsDaily dosesRelease preparationDiseaseLevodopaDosesProlongationTreatmentOverall benefitSinemetPatientsSlight reductionControlled-release levodopa/carbidopa. I. Sinemet CR3 treatment of response fluctuations in Parkinson's disease.
Cedarbaum J, Breck L, Kutt H, McDowell F. Controlled-release levodopa/carbidopa. I. Sinemet CR3 treatment of response fluctuations in Parkinson's disease. Neurology 1987, 37: 233-41. PMID: 3808304, DOI: 10.1212/wnl.37.2.233.Peer-Reviewed Original ResearchConceptsPlasma levodopa levelsLevodopa levelsResponse fluctuationsParkinson's diseaseControlled-release carbidopa/levodopaCarbidopa/levodopaOpen-label trialBioavailability of levodopaStandard SinemetDisability scoresLevodopa preparationsInterdose intervalDaily dosesParkinson's patientsControlled-release formulationClinical performanceDiseaseLevodopaDay consistencyOverall benefitSinemetPatientsDosesTrialsWeeks
1986
Effect of Supplemental Carbidopa on Bioavailability of l-Dopa.
Cedarbaum J, Kutt H, Dhar A, Watkins S, McDowell F. Effect of Supplemental Carbidopa on Bioavailability of l-Dopa. Clinical Neuropharmacology 1986, 9: 153. PMID: 3085927, DOI: 10.1097/00002826-198604000-00006.Peer-Reviewed Original Research