Clinical trial NCT04297683: HEALEY ALS Platform Trial - Master Protocol
Official title: HEALEY ALS Platform Trial
Conditions: Amyotrophic Lateral Sclerosis
Summary: The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS.
Interventions:
description: Drug: Zilucoplan Administration: Subcutaneous injection Dose: Minimum of .0.22 mg/kg daily to a maximum dose of 0.42 mg/kg daily, dependent on weight
name: Zilucoplan
type: Drug
description: Drug: Verdiperstat Administration: Oral Dose: 600mg twice daily
name: Verdiperstat
type: Drug
description: Drug: CNM-Au8 Administration: Oral Dose: 30 mg or 60 mg daily
name: CNM-Au8
type: Drug
description: Drug: Pridopidine Administration: Oral Dose: 45mg twice daily
name: Pridopidine
type: Drug
description: Drug: SLS-005 Trehalose Administration: Infusion Dose: 0.75 g/kg weekly
name: SLS-005 Trehalose
type: Drug
description: Drug: ABBV-CLS-7162 Administration: Oral Dose: Dose 1 or Dose 2
name: ABBV-CLS-7262
type: Drug
description: Drug: DNL343 Administration: Oral Dose: Once per day
name: DNL343
type: Drug
description: Drug: NUZ-001. Administration: Oral. Dose: Once per day.
name: NUZ-001
type: Drug
Study arms:
design_group_description: Participants are randomized to receive either active zilucoplan or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen A - Zilucoplan
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active verdiperstat or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen B - Verdiperstat
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active CNM-Au8 or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen C - CNM-Au8
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active Pridopidine or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen D - Pridopidine
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active SLS-005 Trehalose or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen E - SLS-005 Trehalose
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active ABBV-CLS-7262 or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen F- ABBV-CLS-7262
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active DNL343 or matching placebo.<br/>NO LONGER RECRUITING; RESULTS REPORTED.
design_group_title: Regimen G - DNL343
design_group_type: Experimental
design_group_description: Participants are randomized to receive either active NUZ-001 or matching placebo.
design_group_title: Regimen I - NUZ-001
design_group_type: Experimental
Sponsor: The General Hospital Corp.
Collaborators: The General Hospital Corp.
Drug name mappings:
name: Verdiperstat
lang: EN
name: 海藻糖
lang: CN
name: Trehalose
lang: EN
name: 泽卢克布仑钠
lang: CN
name: Zilucoplan
lang: EN
name: ジルコプランナトリウム
lang: JP
name: Evetifator
lang: EN
name: 普利多匹定
lang: CN
name: Pridopidine
lang: EN
name: Monepantel
lang: EN
name: CNM-Au8
lang: EN
name: Fosigotifator
lang: EN