{"id":4486,"date":"2024-10-14T16:03:56","date_gmt":"2024-10-14T21:03:56","guid":{"rendered":"https:\/\/lsom.uthscsa.edu\/neurology\/?page_id=4486"},"modified":"2024-10-14T17:01:42","modified_gmt":"2024-10-14T22:01:42","slug":"als-amyotrophic-lateral-sclerosis-trials","status":"publish","type":"page","link":"https:\/\/lsom.uthscsa.edu\/neurology\/als-amyotrophic-lateral-sclerosis-trials\/","title":{"rendered":"ALS (Amyotrophic Lateral Sclerosis) Trials"},"content":{"rendered":"

[vc_row][vc_column width=”1\/3″][vc_column_text css=””]\"\"Prinicipal Investigator:
\nCarlayne Jackson, MD[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][\/vc_column][vc_column width=”1\/3″][vc_column_text css=””]<\/p>\n

\"\"<\/p>\n

 <\/p>\n

 <\/p>\n

 <\/p>\n

Study Coordinator:
\nRandee Kent Baron, LVN<\/p>\n

[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=””]<\/p>\n

HEALEY ALS Platform Trial:<\/strong>
\n<\/strong><\/em><\/h2>\n

Eligibility<\/em><\/strong>
\n1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria (Appendix I).
\n2. Age 18 years or older.
\n3. Capable of providing informed consent and complying with study procedures, in the SI\u2019s opinion.
\n4. Time since onset of weakness due to ALS \u2264 36 months at the time of the Master Protocol Screening Visit.
\n5. SVC \u2265 50% of predicted capacity for age, height, and sex at the time of the Master Protocol Screening Visit.
\n6. Participants must either not take riluzole or be on a stable dose of riluzole for \u2265 30 days prior to the Master Protocol Screening Visit. Riluzole-na\u00efve participants are permitted in the study.
\n7. Participants must either not take edaravone or have completed at least one cycle of edaravone prior to the Master Protocol Screening Visit. Edaravone-na\u00efve participants are permitted in the study.
\n8. Participants must have the ability to swallow pills and liquids at the time of the Master Protocol Screening Visit and, in the SI\u2019s opinion, have the ability to swallow pills for the duration of the study.
\n9. Geographically accessible to the site.<\/p>\n

Study Duration<\/em><\/strong>
\nTreatment duration of placebo-controlled regimens is a maximum of 24-weeks for each regimen. An optional open label extension (OLE) may be offered and will be described in the respective RSAs.[\/vc_column_text][vc_empty_space][vc_separator css=””][vc_empty_space][\/vc_column][vc_column][vc_column_text css=””]<\/p>\n

CReATe: Clinical Research in ALS and Related Disorders for Therapeutic Development Consortium:<\/strong>
\n<\/strong><\/em><\/h2>\n

Eligibility<\/em><\/strong>
\n1. Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy)
\n2. Receiving care at a clinical center that uses Epic as its EHR.
\n3. Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).<\/p>\n

Observational Study<\/em><\/strong>
\nReturn visits (frequency dictated by clinical needs)[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

[vc_row][vc_column width=”1\/3″][vc_column_text css=””]Prinicipal Investigator: Carlayne Jackson, MD[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][\/vc_column][vc_column width=”1\/3″][vc_column_text css=””]       Study Coordinator: Randee Kent Baron, LVN [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=””] HEALEY ALS Platform Trial: Eligibility 1. Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria (Appendix I). 2. Age 18 years or older. […]<\/p>\n","protected":false},"author":226,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4486","page","type-page","status-publish","hentry"],"yoast_head":"\nALS (Amyotrophic Lateral Sclerosis) Trials - Department of Neurology<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lsom.uthscsa.edu\/neurology\/als-amyotrophic-lateral-sclerosis-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ALS (Amyotrophic Lateral Sclerosis) Trials - Department of Neurology\" \/>\n<meta property=\"og:description\" content=\"[vc_row][vc_column width=”1\/3″][vc_column_text css=””]Prinicipal Investigator: Carlayne Jackson, MD[\/vc_column_text][\/vc_column][vc_column width=”1\/3″][\/vc_column][vc_column width=”1\/3″][vc_column_text css=””]       Study Coordinator: Randee Kent Baron, LVN [\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column][vc_column_text css=””] HEALEY ALS Platform Trial: Eligibility 1. 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