CY 5022 for ALS Patients

Condition: Amyotrophic lateral sclerosis (ALS)

Eligibility

Key Inclusion Criteria

  • 18-80 years old
  • Diagnosis of familial or sporadic ALS
  • Upright slow vital capacity ≥65% of predicted for age, height and sex at screening
  • Able to swallow tablets

Key Exclusion Criteria

  • Any use of non-invasive ventilation, mechanical ventilation via tracheostomy, or on any form of oxygen supplementation at the time of screening
  • Neurological impairment due to a condition other than ALS
  • Medically significant cardiac, pulmonary, gastrointestinal, musculoskeletal or psychiatric illness that might interfere with ability to comply with study procedures

Full Study Name

A Phase II, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) Clinical Study (IRB no. 48982)

Summary

The purpose of this study is to examine an investigational drug called CK-2127107 as a potential therapy for the improvement of skeletal muscle function in patients with amyotrophic lateral sclerosis (ALS). Researchers aim to determine how CK-2127107 may work in the body and the relationship between the amount of drug taken and its effect on the body, which is known as pharmacodynamics. The study will also evaluate the safety of CK-2127107 and how well it is tolerated in ALS patients, as well as the pharmacokinetics of CK 2127107 (how much CK 2127107 is absorbed into the blood stream and how long it takes to leave the body).

Phase

Phase II


Principal Investigator

Richard Lewis, MD

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