Status:
SUSPENDED
A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
Lead Sponsor:
Immunity Pharma Ltd.
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- Male or female participants ages ≥ 18 to 75 years.
- Participants that have completed study protocol #101/2
- A written informed consent signed prior to any study procedure being performed
- Medically capable to undergo study procedures at the time of study entry
Exclusion
- Participants that did not participate or did not complete 28 treatment days of study protocol #101/2.
- Concurrent therapy, that in the PI's opinion, would interfere with the evaluation of the safety or efficacy of the study medication
- Presence of any other condition or circumstance that, in the judgment of the Investigator, might contraindicate or increase the risk to the participant.
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative serum pregnancy test from protocol 101/2)
- 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
Key Trial Info
Start Date :
December 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03755167
Start Date
December 9 2018
End Date
February 1 2027
Last Update
January 10 2025
Active Locations (2)
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1
Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic
Jerusalem, Israel, 91120
2
Hadassah Medical Center -Motor Neuron Disease Clinic
Jerusalem, Israel