A MULTICENTER, D OUBLE BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF H.P. ACTHAR® GEL IN THE TREATMENT OF SUBJECTS WITH AMYOTROPHIC LATERAL SCLEROSIS

Mallinckrodt ARD Inc,0 个研究点目标入组 0 人开始时间: 2018年7月13日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Male or nonpregnant, nonlactating female subjects 18 to 75 years of age (inclusive) with a diagnosis of clinically definite, clinically probable-laboratory supported, or clinically probable ALS based on the El Escorial criteria and onset of symptoms (defined as date of first muscle weakness or dysarthria) ≤ 2 years prior to the Screening Visit. Subjects must have a systolic blood pressure of ≤ 140 mm Hg, a diastolic blood pressure ≤ 90 mm Hg, and a percent predicted forced vital capacity ≥ 60%. Subjects who have been on a stable dose of 50 mg of riluzole BID ≥ 4 weeks prior to the Screening Visit and will remain on that dose throughout the study (unless taper or discontinuation is required for tolerability issues after the Baseline Visit) may be enrolled.
•Subjects who have completed the 36 week Randomized Treatment Period and are willing and able to continue in the open label extension may do so if, in the opinion of the Investigator, the subject willbenefit from additional treatment with study drug.
•For more details, refer to protocol.

•Subjects may not have tracheostomy, diaphragm pacing, or the ongoing need for assisted ventilation of any type. Subjects may not have taken oral corticosteroids ≥ 10 mg. prednisone/prednisone equivalent for more than 4 consecutive weeks, in the 8 weeks prior to, or any parenteral corticosteroids in the 8 weeks prior to, or any intrathecal/epidural corticosteroids in the 4 weeks prior to, the Screening Visit. Subjects may not have any contraindication as per the United States of America Prescribing Information for Acthar. Subjects cannot have any history of Type 1 or Type 2 diabetes mellitus, or have any clinically significant infection.

发起方