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

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ClinicalTrials.gov Identifier: NCT03755167
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Immunity Pharma Ltd.

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


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: IPL344 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: IPL344
IV IPL344 administered once a day
Drug: IPL344
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 Measures :
  1. Adverse Events (AEs) and Serious Adverse Events (SAEs) Reporting [ Time Frame: upto 36 month ]
    All AEs will be recorded, whether considered minor or serious, drug-related or not


Secondary Outcome Measures :
  1. Changes from baseline in ALS disease progression [ Time Frame: upto 36 months ]
    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


Other Outcome Measures:
  1. Changes from baseline in Pulmonary Function [ Time Frame: upto 36 months ]
    Measured by Vital Capacity (VC)

  2. Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
    Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)

  3. Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]
    Assessed by using a quantitative strength testing tool - hand grip

  4. Changes from baseline in Anti-Depression effect [ Time Frame: upto 36 months ]
    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"

  5. Changes from baseline in Anti-Depression effect [ Time Frame: upto 36 months ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03755167


Contacts
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Contact: Marc Gotkine, M.D. +972 2 6778899 marc@gotkine.com

Sponsors and Collaborators
Immunity Pharma Ltd.

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Responsible Party: Immunity Pharma Ltd.
ClinicalTrials.gov Identifier: NCT03755167     History of Changes
Other Study ID Numbers: 101/3
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases