An Open-Label, Multi-Center, Follow up Study to Protocol 101/2 - Continued Treatment by Intravenously Administered IPL344 to Amyotrophic Lateral Sclerosis (ALS) Patients

Study Purpose:

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

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis (ALS)

Study Type:


Type of Intervention:


Intervention Name:





Phase 2

Study Chair(s)/Principal Investigator(s):



Neals Affiliated?


Coordinating Center Contact Information

Marc Gotkine, M.D. / email hidden; JavaScript is required / +972 2 6778899

Study Sponsor:

Immunity Pharma Ltd.

Estimated Enrollment:


Estimated Study Start Date:

12 / 09 / 2018

Estimated Study Completion Date:

12 / 01 / 2022

Posting Last Modified Date:

09 / 09 / 2019

Date Study Added to

11 / 27 / 2018

Minimum Age:

18 Years

Maximum Age:

75 Years

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

Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic | Recruiting

Jerusalem 91120

Hadassah Medical Center -Motor Neuron Disease Clinic | Recruiting

Marc Gotkune, M.D. / +972 2 6778899 / email hidden; JavaScript is required

Principal Investigator : Marc Kotkine, M.D.