Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criterias

Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, clinically probable ALS, or clinically possible ALS based on the revised El Escorial criteria.
Upright slow vital capacity (SVC)≥ 60% of predicted.
Medically (either independently or with caregiver assistance) able to comply with study procedures, including subcutaneous (SC) injections of study medication and adherence to concomitant medication restrictions.
...
Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, clinically probable ALS, or clinically possible ALS based on the revised El Escorial criteria.
Upright slow vital capacity (SVC)≥ 60% of predicted.
Medically (either independently or with caregiver assistance) able to comply with study procedures, including subcutaneous (SC) injections of study medication and adherence to concomitant medication restrictions.
Patients with ALS ≤ 3 years since symptom onset. Symptom onset is defined as date of first muscle weakness or dysarthria.
Able to provide informed consent.
If taking riluzole and/or Nuedexta®, stable regimen is required for ≥ 30 days prior to screening.

Exclusion Criterias

For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV.
For the purposes of this study, osteoporosis is defined as a history of a lumbar spine and/or femoral neck T-score ≤ -2.5 on bone densitometry (DXA), OR osteoporosis requiring pharmacologic therapy, OR a history of non-traumatic low impact hip or vertebral fracture, OR patient reported history of osteoporosis.
For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening.
...
For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV.
For the purposes of this study, osteoporosis is defined as a history of a lumbar spine and/or femoral neck T-score ≤ -2.5 on bone densitometry (DXA), OR osteoporosis requiring pharmacologic therapy, OR a history of non-traumatic low impact hip or vertebral fracture, OR patient reported history of osteoporosis.
For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening.
Tracheostomy, diaphragm pacing, or ongoing need for assisted ventilation of any type (e.g., bilevel positive airway pressure) for treatment of ALS-related respiratory dysfunction (vital capacity of < 60% predicted, nocturnal desaturation, and/or nocturnal hypoventilation). Patients on assisted ventilation for other reasons require approval from the Medical Monitor. (Supplemental oxygen is acceptable).
Clinically evident cognitive and/or behavioral impairment that in the opinion of the Investigator would impair the ability of the patient to comply with the study procedures.
For the purposes of this study, uncontrolled hypertension is defined as mean systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg on ≥ 3 seated readings taken at least 5 minutes apart during the screening period.
Participation in another therapeutic (drug or device) investigational study within 30 days prior to screening.
Planned treatment with live or live attenuated vaccines once enrolled in the study.
Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS.
Recorded diagnosis or evidence of major psychiatric disorder.
History of prior sensitivity to Acthar or other porcine protein products.
Chronic systemic corticosteroid use, defined as > 20 mg of prednisone or equivalent systemic corticosteroid taken for more than 4 consecutive weeks within 6 months prior to randomization. Topical, inhaled, or intra-articular corticosteroids are allowed.
Type 1 or type 2 diabetes mellitus, or patients currently taking hypoglycemic medication.

Summary

Conditions
Amyotrophic Lateral Sclerosis
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Inclusion Criterias

Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, clinically probable ALS, or clinically possible ALS based on the revised El Escorial criteria.
Upright slow vital capacity (SVC)≥ 60% of predicted.
Medically (either independently or with caregiver assistance) able to comply with study procedures, including subcutaneous (SC) injections of study medication and adherence to concomitant medication restrictions.
...
Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, clinically probable ALS, or clinically possible ALS based on the revised El Escorial criteria.
Upright slow vital capacity (SVC)≥ 60% of predicted.
Medically (either independently or with caregiver assistance) able to comply with study procedures, including subcutaneous (SC) injections of study medication and adherence to concomitant medication restrictions.
Patients with ALS ≤ 3 years since symptom onset. Symptom onset is defined as date of first muscle weakness or dysarthria.
Able to provide informed consent.
If taking riluzole and/or Nuedexta®, stable regimen is required for ≥ 30 days prior to screening.

Exclusion Criterias

For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV.
For the purposes of this study, osteoporosis is defined as a history of a lumbar spine and/or femoral neck T-score ≤ -2.5 on bone densitometry (DXA), OR osteoporosis requiring pharmacologic therapy, OR a history of non-traumatic low impact hip or vertebral fracture, OR patient reported history of osteoporosis.
For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening.
...
For the purposes of this study, congestive heart failure is defined as New York Heart Association Functional Class III-IV.
For the purposes of this study, osteoporosis is defined as a history of a lumbar spine and/or femoral neck T-score ≤ -2.5 on bone densitometry (DXA), OR osteoporosis requiring pharmacologic therapy, OR a history of non-traumatic low impact hip or vertebral fracture, OR patient reported history of osteoporosis.
For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months prior to screening.
Tracheostomy, diaphragm pacing, or ongoing need for assisted ventilation of any type (e.g., bilevel positive airway pressure) for treatment of ALS-related respiratory dysfunction (vital capacity of < 60% predicted, nocturnal desaturation, and/or nocturnal hypoventilation). Patients on assisted ventilation for other reasons require approval from the Medical Monitor. (Supplemental oxygen is acceptable).
Clinically evident cognitive and/or behavioral impairment that in the opinion of the Investigator would impair the ability of the patient to comply with the study procedures.
For the purposes of this study, uncontrolled hypertension is defined as mean systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg on ≥ 3 seated readings taken at least 5 minutes apart during the screening period.
Participation in another therapeutic (drug or device) investigational study within 30 days prior to screening.
Planned treatment with live or live attenuated vaccines once enrolled in the study.
Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS.
Recorded diagnosis or evidence of major psychiatric disorder.
History of prior sensitivity to Acthar or other porcine protein products.
Chronic systemic corticosteroid use, defined as > 20 mg of prednisone or equivalent systemic corticosteroid taken for more than 4 consecutive weeks within 6 months prior to randomization. Topical, inhaled, or intra-articular corticosteroids are allowed.
Type 1 or type 2 diabetes mellitus, or patients currently taking hypoglycemic medication.

Locations

Phoenix, Arizona, 85018
San Antonio, Texas, 78229
Dallas, Texas, 75214
Birmingham, Alabama, 35233
Stanford, California, 94305
...
Phoenix, Arizona, 85018
San Antonio, Texas, 78229
Dallas, Texas, 75214
Birmingham, Alabama, 35233
Stanford, California, 94305
Pittsburgh, Pennsylvania, 15212
Tampa, Florida, 33612
Lincoln, Nebraska, 68506
Miami, Florida, 33136
Atlanta, Georgia, 30322
Kansas City, Kansas, 66160
San Francisco, California, 94115
Jacksonville, Florida, 32224
Rochester, Minnesota, 55905
Houston, Texas, 77030
Memphis, Tennessee, 38104
Hershey, Pennsylvania, 17033

Tracking Information

NCT #
NCT01906658
Collaborators
Not Provided
Investigators
Not Provided