A Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in the Treatment of Subjects With Amyotrophic Lateral Sclerosis



Status:Recruiting
Conditions:Neurology, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 75
Updated:11/23/2018
Start Date:June 22, 2017
End Date:December 2019
Contact:Lisa Fitzgerald, BS, CCRA
Email:clinicaltrials@mnk.com
Phone:800-556-3314

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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

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).

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 213
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 [U]) daily
(QD) or SC matching placebo 0.2 mL QD for 36 weeks, followed by a 3 week taper.

Subjects who complete the 36 week double-blind treatment period are eligible to enter an Open
Label Extension phase where all subjects will receive Acthar 0.2 mL (16 U) daily.

Inclusion Criteria:

1. Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS, or
clinically probable ALS based on revised El Escorial criteria.

2. ALS symptom onset ≤ 2 years prior to the Screening Visit.

3. Subjects who have been on riluzole may enter the study if they have been on a stable
dose of 50 mg BID for ≥ 4 weeks prior to the Screening Visit and, if possible, should
remain on that dose throughout the study.

4. Forced vital capacity (FVC) ≥ 60% at the Screening Visit.

5. Systolic blood pressure ≤ 140 mm Hg and a mean diastolic blood pressure of ≤ 90 mm Hg
at the Screening and Baseline Visits.

Exclusion Criteria:

1. History of use of adrenocorticotropic hormone (ACTH) preparations for treatment of
ALS.

2. Any medical condition known to have an association with motor neuron dysfunction
(other than ALS) which might confound or obscure the diagnosis of ALS.

3. Subject has tracheostomy, diaphragm pacing, or ongoing (used for greater than 7
consecutive days in the 4 weeks prior to the Screening Visit) need for assisted
ventilation of any type.

4. History of chronic active hepatitis including active or chronic hepatitis B, or acute
or chronic hepatitis C.

5. History of tuberculosis (TB) infection, any signs/symptoms of TB, or any close contact
with an individual with an active TB infection.

6. Clinically significant infection requiring intravenous administration of antibiotics
and hospitalization in the 4 weeks prior to the Screening Visit.

7. Subject has used edaravone in the 1 week prior to the Screening Visit or in the 2
weeks prior to the Randomization Visit.
We found this trial at
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Washington, District of Columbia 20052
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
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Los Angeles, California 90095
310-825-4321
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Augusta, Georgia 30912
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Austin, Texas 78703
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601 North Caroline Street
Baltimore, Maryland 21287
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Colchester, Vermont 05446
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Colorado Springs, Colorado 80907
Phone: 719-389-1129
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Cordova, Tennessee 38018
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Dallas, Texas 75214
Phone: 214-827-3610
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Edmonton, Alberta
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Grand Rapids, Michigan 49503
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500 University Drive
Hershey, Pennsylvania 17033
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Houston, Texas 77030
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355 West 16th Street
Indianapolis, Indiana 46202
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
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Las Vegas, Nevada 89145
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Lincoln, Nebraska 68506
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11234 Anderson Street
Loma Linda, California 92354
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Neptune, New Jersey 07754
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New York, New York 10021
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101 The City Drive South
Orange, California 92868
714-456-7890
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Philadelphia, Pennsylvania 19140
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Phoenix, Arizona 85028
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
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Portland, Oregon 97213
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Richmond, Virginia 23298
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
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San Francisco, California 94143
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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Seattle, Washington 98122
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3700 O St NW
Washington, District of Columbia 20057
(202) 687-0100
Georgetown University Georgetown University is one of the world's leading academic and research institutions, offering...
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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