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A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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This is a prospective, open-label, follow up study to protocol 101/2 - continued treatment by IPL344 IV administered once a day in up to 15 participants with ALS. The study is designed to determine the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months

Inclusion Criteria:
1. Male or female participants ages ≥ 18 to 75 years.
2. Participants that have completed study protocol #101/2
3. A written informed consent signed prior to any study procedure being performed
4. Medically capable to undergo study procedures at the time of study entry
Exclusion Criteria:
1. Participants that did not participate or did not complete 28 treatment days of study
protocol #101/2.
2. Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of
the safety or efficacy of the study medication
3. Presence of any other condition or circumstance that, in the judgment of the
Investigator, might contraindicate or increase the risk to the participant.
4. Females must not be lactating or pregnant at Screening or Baseline (as documented by a
negative serum pregnancy test from protocol 101/2)
5. 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

Locations
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ALS Research Collaborative
Thank You to Our Sponsors
Mitsubishi Tanabe Pharma