A Multicenter, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis

Gender:

Minimum Age:

Maximum Age:

Min Vital Capacity (% predicted normal):

Time since Symptom Onset:

Time since Diagnosis:

Can participants use Riluzole?

Inclusion Criteria:

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.
On riluzole 50 mg twice a day for ≥ 4 weeks prior to the Screening Visit.
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.

Exclusion Criteria:

History of use of adrenocorticotropic hormone (ACTH) preparations for treatment of ALS.
Any medical condition known to have an association with motor neuron dysfunction (other than ALS) which might confound or obscure the diagnosis of ALS.
Requires nocturnal continuous positive airway pressure or bilevel positive airway pressure.
Tracheostomy, diaphragm pacing, or ongoing need for assisted ventilation of any type at Screening Visit.
Known contraindication(s) to Acthar.
History of chronic active hepatitis including active or chronic hepatitis B, or acute or chronic hepatitis C.
History of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact with an individual with an active TB infection.
Clinically significant infection requiring intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the Screening Visit.