HEALEY ALS Platform Trial - Master Protocol

Conditions

• Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zilucoplan — DRUG
  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
• Verdiperstat — DRUG
  Drug: Verdiperstat Administration: Oral Dose: 600mg twice daily
• CNM-Au8 — DRUG
  Drug: CNM-Au8 Administration: Oral Dose: 30 mg or 60 mg daily
• Pridopidine — DRUG
  Drug: Pridopidine Administration: Oral Dose: 45mg twice daily
• SLS-005 Trehalose — DRUG
  Drug: SLS-005 Trehalose Administration: Infusion Dose: 0.75 g/kg weekly
• ABBV-CLS-7262 — DRUG
  Drug: ABBV-CLS-7162 Administration: Oral Dose: Dose 1 or Dose 2
• DNL343 — DRUG
  Drug: DNL343 Administration: Oral Dose: Once per day
• NUZ-001 — DRUG
  Drug: NUZ-001. Administration: Oral. Dose: Once per day.

Study Details

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.

Key Dates

Start date

Jun 14, 2020

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen A - Zilucoplan
  Participants are randomized to receive either active zilucoplan or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen B - Verdiperstat
  Participants are randomized to receive either active verdiperstat or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen C - CNM-Au8
  Participants are randomized to receive either active CNM-Au8 or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen D - Pridopidine
  Participants are randomized to receive either active Pridopidine or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen E - SLS-005 Trehalose
  Participants are randomized to receive either active SLS-005 Trehalose or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen F- ABBV-CLS-7262
  Participants are randomized to receive either active ABBV-CLS-7262 or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen G - DNL343
  Participants are randomized to receive either active DNL343 or matching placebo. NO LONGER RECRUITING; RESULTS REPORTED.
• Experimental: Regimen I - NUZ-001
  Participants are randomized to receive either active NUZ-001 or matching placebo.

Primary Outcome Measure

Disease Progression [ Time Frame: 36 Weeks ]

Central Contacts

• HEALEY Center for ALS at Massachusetts General Hospital
  833-425-8257 (HALT ALS)
  [email protected]

Locations (81)

Find similar trials in Phoenix, AZ

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