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A Phase 3, Randomized, Double-blind, Placebo-controlled Study To Evaluate The Efficacy And Safety Of Pridopidine In Participants With Amyotrophic Lateral Sclerosis
Jacksonville, FL
The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:
Does pridopidine slow disease progression of ALS?
Researchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.
Participants will:
Take pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.
Visit the clinic once every 1-3 months for checkups and tests
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HEALEY ALS Platform Trial (HEALEY)
Jacksonville, FL
Rochester, MN
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and effectiveness of investigational products for the treatment of ALS.
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PLS Natural History Study (PLS)
Jacksonville, FL
Rochester, MN
The purpose of this study is to develop a natural history dataset and biorepository of early Primary Lateral Sclerosis (PLS) and well-established PLS cases for future clinical trials.
Contact Us for the Latest Status
Closed for Enrollment
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial To Evaluate Efficacy And Safety Of Lenabasum In Dermatomyositis
Scottsdale/Phoenix, AZ
Jacksonville, FL
what is the efficacy of lenabasum compared to placebo in subjects with dermatomyositis (DM) as measured by TotalImprovement Score (TIS)
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A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study To Evaluate The Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, And Immunogenicity Of Efgartigimod PH20 SC In Participants Aged 18 Years And Older With Active Idiopathic Inflammatory Myopathy
Jacksonville, FL
The purpose of this study is to measure the treatment response from Efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM).
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A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy
Jacksonville, FL
The purpose of this study is to measure the long-term safety and tolerability of efgartigimod PH20 SC in adult participants with Idiopathic Inflammatory Myopathy (IIM) who previously participated in
ARGX-113-2007. Secondary objectives include efficacy measures of efgartigimod PH20 SC in participants with IIM.
IIM is a disease of the immune system that causes weakness of the pelvic muscles, the shoulder girdle muscles, or both. These symptoms lead to difficulties in ADL and reduce quality of life. The typical treatment for IIM is high-dose glucocorticoids combined with immunosuppressive drugs.
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A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study To Determine The Efficacy And Safety Of ABC008 In The Treatment Of Subjects With Inclusion Body Myositis
Jacksonville, FL
Rochester, MN
The purpose of this study is to determine the effectiveness, safety, and tolerability of subcutaneous (SC) dosing of ABC008 in subjects with inclusion body myositis (IBM).
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A Second Intermediate-Size Expanded Access Protocol (EAP) For Pridopidine In People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)
Jacksonville, FL
Rochester, MN
The purpose of this study is to provide access to the investigational product, pridopidine, for up to 200 participants with ALS who are ineligible for clinical trials.
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An Open-label, Multicenter Study To Evaluate The Long-term Safety And Efficacy Of Ulviprubart (ABC008) In Subjects Who Have Completed A Trial Of Ulviprubart For The Treatment Of Inclusion Body Myositis
Jacksonville, FL
Rochester, MN
ABC008-IBM-202 is an open-label, multicenter study to evaluate the safety and efficacy of long-term administration of ulviprubart (ABC008) in subjects with IBM who have completed either Study ABC008-IBM-101 or Study ABC008-IBM-201. Subjects may be enrolled in this study if they meet study eligibility criteria and:
* Have completed the Part 2 (Multiple Ascending Dose \[MAD\]) End of-Treatment (EOT) Visit in Study ABC008-IBM-101; subjects who continued further on into Part 3 of the study (MAD Extension) prior to enrolling in this study are also eligible; OR
* Have completed the Week 80 Follow-up Visit in Study ABC008-IBM-201.
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FRT- 2019: Pilot Study of Electrical Impedance Myography as an Outcome Measure in Myositis
Jacksonville, FL
The purpose of this study is to assess Electrical Impedance Myography (EIM) as an outcome measure in patients with Idiiopathic Inflammatory Myopathies (IIM) or Myositis.
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