Last updated on February 2019

A Study of IPL344 in the Treatment of ALS Patients

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Amyotrophic Lateral Sclerosis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Male or female participants ages 18 to 75 years
  • Consenting participants fulfilling the El Escorial criteria for probable and definite ALS (sporadic and familial)
  • Participant has ALSFRS-R score 42 and a disease progression rate greater than 0.65 ALSFRS-R points per month over the last 3-12 months. The latest ALSFRS-R test should be no more than 6 weeks before screening visit
  • Previous data on Forced Vital Capacity (FVC) of 60% at least 3 months before screening and not more than 12 months
  • Written informed consent consistent with ICH-GCP and local laws, signed prior to any study procedures being performed
  • BMI 18.5 to 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg
  • If taking riluzole or edaravone, the participant must be on a stable dose for 30 days prior to Day 1 and expected to remain at that dose until the final study visit
  • Medically able to undergo the study procedures, and to adhere to the visit schedule at the time of study entry

Exclusion Criteria:

  • Concurrent therapy that, in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
  • Co-existing psychiatric disorder excluding a depression disorder occurred after ALS diagnosis
  • Participant is a respiratory dependent
  • Subjects with a significant pulmonary disorder not attributed to ALS
  • Slow Vital Capacity (SVC) <60
  • Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
  • History of HIV, positive HBV or HCV serology
  • Participants suffering from significant cardiac, or any other disease that may endanger the participant or interfere with the ability to interpret the results
  • A participant with an active infections
  • Documented active cancer
  • Unable to place PICC line or permanent port
  • Treatment with another investigational drug, biological agent, or device within 2 months of the first dose, or investigational cell therapy within 6 months of the first dose
  • Participants that reside 90-minute drive or more from the site
  • Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [-hCG] (or human chorionic gonadotropin [hCG])
  • Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling or unable to use an effective method of contraception throughout the trial

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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