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

Study Purpose:

This is a multicenter, multiple dose study to examine the effect of H.P. Acthar® (Acthar) on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, currently recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Susan VanMeter, Mallinckrodt

Clinicaltrials.gov ID (11 digit #):

NCT03068754

Neals Affiliated?

No

Coordinating Center Contact Information


Roman Bilyk / .(JavaScript must be enabled to view this email address) / 800-556-3314
.(JavaScript must be enabled to view this email address)

Full Study Summary:

This is a multicenter, multiple dose study to examine the effect of Acthar on functional decline in adult subjects with amyotrophic lateral sclerosis (ALS). Approximately 195 subjects will be enrolled.

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 ) daily (QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3 week taper.

Study Sponsor:

Mallinckrodt

Participant Duration:

Estimated Enrollment:

195

Estimated Study Start Date:

06/14/2017

Estimated Study Completion Date:

12/31/2019

Posting Last Modified Date:

08/25/2017

Date Study Added to alsconsortium.org:

08/25/2017
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Min Vital Capacity (% predicted normal):

    60

    Time since Symptom Onset:

    <24 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    Neuromuscular Research Center
    Phoenix, Arizona 85208
    United States

    Loma Linda University Health System, Department of Neurology
    Recruiting Loma Linda, California 92354
    United States

    Colorado Springs Neurological Associates
    Colorado Springs, Colorado 80907
    United States

    GW Medical Faculty Associates
    Washington, D.C., District of Columbia 20037
    United States

    University of South Florida
    Tampa, Florida 33609
    United States

    Wesley Neurology Clinic
    Cordova, Tennessee 38018
    United States

    Texas Neurology, P.A.
    Dallas, Texas 75215
    United States

    Medical College of Wisconsin/Froedtert Hospital
    Milwaukee, Wisconsin 53226
    United States