A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis

Purpose

This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS). View more study details on ClinicalTrials.gov.

Procedures

  • Following a screening period of up to 28 days, subjects with ALS and symptom onset (defined as first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit will be randomized on a 2:1 basis to receive subcutaneous (SC) Acthar 0.2 mL (16 Units [U]) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3 week taper.
  • Subjects who complete the 36 week double-blind treatment period are eligible to enter an Open Label Extension phase where all subjects will receive Acthar 0.2 mL (16 U) daily.

For more details about study procedures, please contact Derek Ridgeway:

Eligibility 

  • Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, or clinically probable ALS based on revised El Escorial criteria.
  • ALS symptom onset ≤ 2 years prior to the Screening Visit.
  • Subjects who have been on riluzole may enter the study if they have been on a stable dose of 50 mg BID for ≥ 4 weeks prior to the Screening Visit and, if possible, should remain on that dose throughout the study.
  • Forced vital capacity (FVC) ≥ 60% at the Screening Visit.
  • Systolic blood pressure ≤ 140 mm Hg and a mean diastolic blood pressure of ≤ 90 mm Hg at the Screening and Baseline Visits.

For more details about eligibility criteria, please contact Derek Ridgeway:

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

Amyotrophic lateral sclerosis, ALS - resources, ALS, Neurology

Principal Investigator

James Wymer, MD, PhD

Department

Neurology

Contact Information

Derek.Ridgeway@neurology.ufl.edu

352-273-9194


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
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Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
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