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Trial record 2 of 3 for:    EHP-101

Evaluation of Safety, Tolerability and Preliminary Efficacy of EHP-101 in Relapsing Forms of Multiple Sclerosis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04909502
Recruitment Status : Suspended (Temporary recruitment pause to re-assess the protocol design, specifically the eligibility criteria)
First Posted : June 1, 2021
Last Update Posted : October 21, 2022
Sponsor:
Information provided by (Responsible Party):
Emerald Health Pharmaceuticals

Brief Summary:
The purpose of this trial is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in adult subjects with Relapsing Forms of Multiple Sclerosis (RMS).

Condition or disease Intervention/treatment Phase
Relapsing Forms of Multiple Sclerosis Drug: EHP-101 25 mg OD Drug: EHP-101 25 mg BID Drug: EHP-101 50 mg OD Drug: EHP-101 50 mg BID Phase 2

Detailed Description:
An interventional, open label, randomized design will be used to test safety, tolerability, pharmacokinetics, and preliminary efficacy of EHP-101 in 50 patients ≥ 18 and ≤ 55 years of age with documented RMS. There will be a screening period of up to 28 days, 168 days treatment period, and 28 days follow-up.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will initially be conducted with 2 treatment arms starting in parallel. Patients will initially receive a 25 mg OD or a 25 mg BID dose. After 28 days, each patient will increase to a 50 mg OD or 50mg BID dose level, respectively, if deemed to be safe by the investigator.
Masking: None (Open Label)
Masking Description: Open Label design
Primary Purpose: Treatment
Official Title: A Phase IIa, Open-label, Multicentre Dose-Finding Trial in Patients With Relapsing Forms of Multiple Sclerosis (RMS) to Evaluate the Safety, Tolerability and Preliminary Efficacy of EHP-101
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EHP-101 Once a day (OD) Drug: EHP-101 25 mg OD
25 mg OD during the first 28 Days of the trial

Drug: EHP-101 50 mg OD
After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial

Experimental: EHP-101 Twice a day (BID) Drug: EHP-101 25 mg BID
25 mg BID during the first 28 Days of the trial

Drug: EHP-101 50 mg BID
After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial




Primary Outcome Measures :
  1. Incidence and severity of Treatment Emergent Adverse Events [ Time Frame: 168 days (24 weeks) ]
    This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments


Secondary Outcome Measures :
  1. Brain lesion activity measured by MRI [ Time Frame: 168 days (24 weeks) ]
  2. Disease progression measured by MS Functional Composite (MSFC) [ Time Frame: 168 days (24 weeks) ]
    The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality

  3. Disease progression measured by Expanded Disability Status Scale (EDSS) [ Time Frame: 168 days (24 weeks) ]
    The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner

  4. Disease progression measured by Symbol Digit Modalities Test (SDMT) [ Time Frame: 168 days (24 weeks) ]
    The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution

  5. Disability status measured by MS Functional Composite (MSFC) [ Time Frame: 168 days (24 weeks) ]
    The MSFC consists of three assessments of walking speed, processing speed and finger dexterity. The scores are combined to provide a Z-score (number of standard deviations away from mean of a normal population) with lower scores representing greater abnormality

  6. Disability status measured by Expanded Disability Status Scale (EDSS) [ Time Frame: 168 days (24 weeks) ]
    The EDSS is an ordinal scale used for assessing neurological impairment of MS based on a neurological examination. It consists of scores in each of seven functional systems (FS) and an ambulation score that are then combined to determine the EDSS [ranging from 0 (normal) to 10 (death due to MS)]. The FSs are the Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel & Bladder, and Cerebral functions. The FSs and EDSS steps will be assessed in a standardized manner

  7. Disability status measured by Symbol Digit Modalities Test (SDMT) [ Time Frame: 168 days (24 weeks) ]
    The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0-110 in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution

  8. Time to first relapse [ Time Frame: 168 days (24 weeks) ]
  9. Preliminary Annualized Relapse Rate (ARR) [ Time Frame: 168 days (24 weeks) ]
  10. Percent of patients who experience a relapse [ Time Frame: 168 days (24 weeks) ]
  11. Proportion of patients who remain qualified as relapse-free [ Time Frame: 168 days (24 weeks) ]
  12. Change in blood levels of neurofilament light chain (NfL) [ Time Frame: Baseline, 28 Days, 56 Days, 84 Days, 112 Days, 140 Days, 168 Days ]

Other Outcome Measures:
  1. Microstructural analysis and assessment of potential remyelination measured by Magnetization Transfer Ratio (MTR) [ Time Frame: 168 days (24 weeks) ]
  2. Assessment of white matter diffusivity and integrity measured by Diffusion Tensor Imaging (DTI) [ Time Frame: 168 days (24 weeks) ]
  3. VCE-004.8 plasma trough levels for all patients [ Time Frame: 197 Days (28 weeks) ]
  4. Pharmacokinetic profile of VCE-004.8 in terms of maximum observed plasma concentration (Cmax) [ Time Frame: Day 1 (pre-dose) and at 0.5, 1, 2, 3, 4 and 6 hours post-dose on Day 1 and Day 28 ]
  5. Pharmacokinetic profile of VCE-004.8 in terms of area under the plasma concentration-time curve (AUC) [ Time Frame: Day 1 (pre-dose) and at 0.5, 1, 2, 3, 4 and 6 hours post-dose on Day 1 and Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female adults aged 18 to 55 years at the time of consent;
  • Confirmed diagnosis of MS according to the revised 2017 McDonald criteria;
  • Relapsing forms of MS (RMS) including Relapsing-Remitting MS (RRMS) and active Secondary Progressive MS (SPMS);
  • Patients must have experienced at least 1 of the following within 12 months prior to Visit 1: an acute clinical relapse, gadolinium-enhancing T1 lesions on brain or spinal cord magnetic resonance imaging (MRI), or new T2 lesion(s) on brain or spinal cord MRI;
  • Neurologically stable with no evidence of clinical relapse of MS or corticosteroid treatment within 28 days prior to the first investigational product administration;
  • Naïve to prior MS treatment or discontinuing current MS treatment due to (1) intolerability, (2) laboratory abnormalities, (3) current treatment perceived by the patient to be ineffective, (4) patient preference, or (5) based on investigator judgement to switch MS therapy;
  • An EDSS score of 0 to 6.0 (inclusive) at screening and enrolment visit;
  • Willing and able to provide informed consent and capable of understanding and complying with the protocol.

Exclusion Criteria:

  • Primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS);
  • Relapse during the 28 days prior to first investigational product administration;
  • Total lymphoid irradiation, T-cell or T-cell receptor vaccination, total body irradiation, or total lymphoid irradiation at any time;
  • Treatment with alemtuzumab, mitoxantrone, cyclophosphamide or cladribine at any time;
  • MS treatment that may impact the efficacy or safety assessment defined as follows:

    1. 52 weeks or less prior to first investigational product administration: Immunosuppressant agents (e.g., cyclosporine, methotrexate, mycophenolate)
    2. 36 weeks or less prior to first investigational product administration: CD20 depletion therapies such as rituximab, ocrelizumab, ofatumumab or others. Condition for inclusion of patients who had CD20 depletion therapies more than 36 weeks prior to the first investigational product administration: may only be included if there is no clinically relevant B cell depletion and possible safety risk to patients based on the Investigator's opinion.
    3. 12 weeks or less prior to first investigational product administration: natalizumab
    4. 8 weeks or less prior to first investigational product administration: dimethyl-fumarate fingolimod
    5. 4 weeks or less prior to first investigational product administration: corticosteroids intravenous immunoglobulin (IVIG) ozanimod, siponimod, or ponesimod glatiramer acetate interferons
    6. 2 weeks or less prior to first investigational product administration: teriflunomide. Subject must exhibit no active agent in serum levels; cholestyramine or activated charcoal washout may be used to achieve this;
  • Any one of the following values for laboratory test at screening:

    1. Haemoglobin < 9 g/dL;
    2. Neutrophils < 1.0 x 10^9/L;
    3. Platelets < 75 x 10^9/L;
    4. Serum transaminases > 2.0 x upper limit of normal;
    5. Total bilirubin ≥ 1.5 x upper limit of normal;
    6. Thyroid-stimulating hormone level >10% above of the upper limit of normal;
    7. Estimated glomerular filtration rate ≤60 mL/min/1.73m2 (using the Cockcroft-Gault equation);
    8. Lymphocytes < 1 × 10^9/L;

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): NCT04909502


Locations
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United States, Alabama
North Central Neurology Associates
Cullman, Alabama, United States, 35058
United States, California
Fullerton Neurology and Headache Center
Fullerton, California, United States, 92835
United States, Florida
Accel Research Sites - Brain and Spine Institute of Port Orange
Port Orange, Florida, United States, 32127
Australia, Victoria
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
Emerald Health Pharmaceuticals
Additional Information:
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Responsible Party: Emerald Health Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04909502    
Other Study ID Numbers: EHP-101-MS02
First Posted: June 1, 2021    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Emerald Health Pharmaceuticals:
Multiple Sclerosis
Nervous System Diseases
Demyelinating Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Relapsing Forms of Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Relapsing Secondary Progressive Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases