Back to resultsA Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
IPL344
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS)
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease ClinicRecruiting
- Hadassah Medical Center -Motor Neuron Disease ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPL344
Arm Description
IV IPL344 administered once a day
Outcomes
Primary Outcome Measures
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
All AEs will be recorded, whether considered minor or serious, drug-related or not
Secondary Outcome Measures
Changes from baseline in ALS disease progression
Evaluated by the Amyotrophic Lateral Sclerosis Functional Rating Scale(ALSFRS-R). The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing
Full Information
NCT ID
NCT03755167
First Posted
November 21, 2018
Last Updated
September 6, 2019
Sponsor
Immunity Pharma Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03755167
Brief Title
A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2018 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunity Pharma Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 the safety, tolerability and initial efficacy of IPL344, administered once a day, by IV infusion for up to 36 months
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPL344
Arm Type
Experimental
Arm Description
IV IPL344 administered once a day
Intervention Type
Drug
Intervention Name(s)
IPL344
Intervention Description
IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
Primary Outcome Measure Information:
Title
Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting
Description
All AEs will be recorded, whether considered minor or serious, drug-related or not
Time Frame
upto 36 month
Secondary Outcome Measure Information:
Title
Changes from baseline in ALS disease progression
Description
Evaluated by the Amyotrophic Lateral Sclerosis Functional Rating Scale(ALSFRS-R). The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing
Time Frame
upto 36 months
Other Pre-specified Outcome Measures:
Title
Changes from baseline in Pulmonary Function
Description
Measured by Vital Capacity (VC)
Time Frame
upto 36 months
Title
Changes from baseline in Muscle strength
Description
Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)
Time Frame
upto 36 months
Title
Changes from baseline in Muscle strength
Description
Assessed by using a quantitative strength testing tool - hand grip
Time Frame
upto 36 months
Title
Changes from baseline in Anti-Depression effect
Description
Evaluated by ALS Depression Inventory (ADI-12). Scales: For each question, the following is selected: "I fully agree", "I agree", "I don't agree", "I do not agree at all"
Time Frame
upto 36 months
Title
Changes from baseline in Anti-Depression effect
Description
Evaluated by the Hospital Anxiety and Depression Scale (HADS). The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains
Time Frame
upto 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Gotkine, M.D.
Phone
+972 2 6778899
Email
marc@gotkine.com
Facility Information:
Facility Name
Hadassah Medical Center/Neuromuscular / EMG service and ALS / Motor Neuron Disease Clinic
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center -Motor Neuron Disease Clinic
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Gotkune, M.D.
Phone
+972 2 6778899
Email
marc@gotkine.com
First Name & Middle Initial & Last Name & Degree
Marc Kotkine, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
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