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
Investigating the Effect of an Investigational Medication on ALS Symptoms
Brief description of study.
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.
Detailed description of study
The purpose of this study is to examine the effect of Acthar on decline in adult subjects with ALS.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: amyotrophic lateral sclerosis
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Age: 18 years - 75 years
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Gender: All
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
This study investigates the effect of an investigational medication on adults with Amyotrophic Lateral Sclerosis (ALS). ALS is a condition that affects nerve cells in the brain and spinal cord, leading to loss of muscle control. The purpose of this study is to see if adding the investigational medication to an existing treatment can slow down the progression of ALS symptoms or extend survival time.
Participants in the study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will involve regular monitoring of ALS symptoms and overall health to assess the effects of the treatment.
- Who can participate: Adults diagnosed with ALS who had symptom onset within the last 2 years and have been on a specific medication for at least 4 weeks may participate. Participants must not have been in recent ALS trials and should not have certain medical conditions or histories, such as diabetes or active infections.
- Study details: Participants will be assigned to receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study involves regular health assessments and monitoring of ALS symptoms.
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