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

Overview

The purpose of this study is to determine if adding Acthar to riluzole will further help by either slowing down how fast ALS symptoms progress and/or increasing the time before you die.

Description

The purpose of this study is to examine the effect of Acthar on decline in adult subjects with ALS.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: amyotrophic lateral sclerosis,Lou Gehrig's disease
  • Age: Between 18 Years - 75 Years
  • Gender: Male or Female

Inclusion Criteria
Must have a diagnosis of ALS
Must have had ALS symptom onset less than or equal to 2 years prior to the Screening Visit
Must have been on riluzole 50 mg bi-daily for greater than or equal to 4 weeks prior to the Screening Visit and, if possible, should remain on that dose throughout the study
Exclusion Criteria
Has participated in any ALS therapeutic trials in the 24 weeks prior to the Screening Visit or any non-ALS therapeutic trial in the 4 weeks prior to the Screening Visit
Unwilling to receive, or is intolerant of injections
Any history of use of ACTH preparations for treatment of ALS
History of sensitivity the ACTH preparations or to porcine protein products
Has any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
Has tracheostomy, diaphragm pacing, or ongoing need for assisted ventilation of any type
Has used oral corticosteroids in the 24 weeks prior to the Screening Visit
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
Has a clinically significant infection requiring intravenous administration of antibiotics and hospitalization in the 4 weeks prior to the Screening Visit
Has known immune compromised status
Has Type 1 or Type 2 diabetes mellitus
Has any solid tumor malignancy currently diagnosed or undergoing therapy, or has received therapy for any solid tumor malignancy in the 5 years prior to the Screening Visit, with the exception of treated and cured basal cell carcinoma, treated and cured squamous cell carcinoma of the skin, and treated and cured carcinoma in situ of the cervix
Has a diagnosis of, is undergoing therapy for, or has received therapy for a hematologic malignancy in the 5 years prior to the Screening Visit


Additional Information:
Participants will be compensated for their participation.

Updated on 20 Nov 2022 . Study ID: TX8017

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What happens next?
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