A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03755167|
Recruitment Status : Not yet recruiting
First Posted : November 27, 2018
Last Update Posted : November 28, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
IV IPL344 administered once a day
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).
- 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
- 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
- Changes from baseline in Pulmonary Function [ Time Frame: upto 36 months ]Measured by Vital Capacity (VC)
- Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]Assessed by using a quantitative strength testing tool, Hand Held Dynamometry (HHD)
- Changes from baseline in Muscle strength [ Time Frame: upto 36 months ]Assessed by using a quantitative strength testing tool - hand grip
- 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"
- 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
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
|Contact: Marc Gotkine, M.D.||+972 2 firstname.lastname@example.org|