Trial Profile
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
Status:
Discontinued
Phase of Trial:
Phase II/III
Latest Information Update: 16 Oct 2020
Price :
$35
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At a glance
- Drugs Corticotropin (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions; Proof of concept; Registrational; Therapeutic Use
- Acronyms PENNANT
- Sponsors Mallinckrodt plc
- 16 Jul 2019 According to a Mallinckrodt plc media release, the company agreed that the study should be permanently halted in the interest of patient safety for this fragile population, one for which pneumonia is a particularly serious condition. Enrollment in the study will cease immediately, and those patients already enrolled will be tapered off the drug before discontinuing use.
- 16 Jul 2019 According to a Mallinckrodt plc media release, the DSMB's recommendation was based on the specific concern for pneumonia, which occurred at a higher rate in the ALS patients receiving Acthar Gel compared to those on placebo; the board also mentioned other adverse events specific to this patient population. The DSMB noted the proportion of patients who have completed Week 36- the primary endpoint target, precludes a definitive determination of a treatment effect.
- 16 Jul 2019 According to a Mallinckrodt plc media release, the company has decided to permanently discontinuing the trial, after careful consideration of a recommendation by the independent Data and Safety Monitoring Board (DSMB). The lack of a clear efficacy signal for this ALS patient population combined with the potential risk of pneumonia led to the board's recommendation.