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
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
IPL344
Placebo:
No
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Marc Gotkine, M.D. / email hidden; JavaScript is required / +972 2 6778899
Study Sponsor:
Immunity Pharma Ltd.
Estimated Enrollment:
15
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 neals.org:
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
Israel
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.
Jerusalem
Israel