{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Berry JD"],"funding":["NCATS NIH HHS","NINDS NIH HHS"],"pagination":["e61177"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC3629222"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["8(4)"],"pubmed_abstract":["Objectives
Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing.Methods
In Stage 1, 66 subjects at ten clinical sites were enrolled and randomized equally into three study groups receiving intravenous placebo, ceftriaxone 2 grams daily or ceftriaxone 4 grams daily divided BID. Participants provided serum"],"journal":["PloS one"],"pubmed_title":["Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis."],"pmcid":["PMC3629222"],"funding_grant_id":["U01 NS049640-05","U01 NS049640","R01 NS049640","UL1 TR000448"],"pubmed_authors":["Caress JB","Simpson E","Keroack M","Conwit R","Rezania K","Rosenfeld J","Vriesendorp F","Berry JD","Katz J","Pascuzzi R","Rothstein JD","Greenblatt DJ","Pestronk A","Glass J","David WS","Cudkowicz ME","Shefner JM","Schoenfeld D","Krivickas L","Felsenstein D","Northeast ALS Consortium"],"additional_accession":[]},"is_claimable":false,"name":"Design and initial results of a multi-phase randomized trial of ceftriaxone in amyotrophic lateral sclerosis.","description":"Objectives
Ceftriaxone increases expression of the astrocytic glutamate transporter, EAAT2, which might protect from glutamate-mediated excitotoxicity. A trial using a novel three stage nonstop design, incorporating Phases I-III, tested ceftriaxone in ALS. Stage 1 determined the cerebrospinal fluid pharmacokinetics of ceftriaxone in subjects with ALS. Stage 2 evaluated safety and tolerability for 20-weeks. Analysis of the pharmacokinetics, tolerability, and safety was used to determine the ceftriaxone dosage for Stage 3 efficacy testing.Methods
In Stage 1, 66 subjects at ten clinical sites were enrolled and randomized equally into three study groups receiving intravenous placebo, ceftriaxone 2 grams daily or ceftriaxone 4 grams daily divided BID. Participants provided serum","dates":{"release":"2013-01-01T00:00:00Z","publication":"2013","modification":"2026-05-02T08:17:15.922Z","creation":"2019-03-26T23:14:10Z"},"accession":"S-EPMC3629222","cross_references":{"pubmed":["23613806"],"doi":["10.1371/journal.pone.0061177"]}}