Evaluate Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and Quality of Life in MS Patients

NCT03710655 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: MSKIM10418
• Study Type: interventional
• Target: 468
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine the effects of Apitox add-on therapy on the progression of disability in all forms of multiple sclerosis (MS) utilizing the Expanded Disability Status Scale (EDSS) and the MS Functional Composite (MSFC) measure. b. Evaluate the safety and tolerability of add-on Apitox therapy for the treatment of patients with all forms of MS: relapsing-remitting MS (RRMS), primary progressive MS (PPMS) and secondary progressive MS (SPMS). The

Conditions

Multiple Sclerosis

Keywords

QOL and pain

Outcome Measures

Primary Outcomes (2)

• Expanded Disability Status Scale (EDSS)

  16 weeks

• MS Functional Composite (MSFC)

  16 weeks

Secondary Outcomes (6)

• Quality of life questionnaire (MSQoL-54)

  16 weeks

• Functional System Scores (FSS)

  16 weeks

• Pain Intensity Numerical Rating Scale (PI-NRS)

  16 weeks

• Patient Global Impression of Change (PGIC)

  16 weeks

• Patient Global Assessment (PGA)

  16 weeks

Study Arms (2)

treatment group

EXPERIMENTAL

skin test, dose escalation, final dose of 1.5mg weekly over 16 weeks of Apitox pure honeybee toxin

Drug: Apitox - pure honeybee toxin

placebo group

PLACEBO COMPARATOR

histamine placebo administered intradermally in dose escalation, final dose of 1.5mg weekly over 16 weeks

Drug: Placebo

Interventions

Apitox - pure honeybee toxin DRUG

Intradermal injection of 0.01 microliters

Also known as: Apitoxin

treatment group

Placebo DRUG

Intradermal injection of 0.01 microliters

Also known as: histamine

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have provided written informed consent and authorization for disclosure of protected health information must meet the following criteria:
• Men or women aged 18 to 65 years inclusive.
• Confirmed diagnosis of MS as defined by the McDonald criteria \[25\].
• Receiving disease modifying treatment and/or treatment for symptoms of MS at baseline. Subjects will be allowed to continue their MS treatment regimens throughout the trial (see Sections 7.4 and 7.5 for prior and allowed medications, respectively, during the trial).
• Females of childbearing potential must be willing to use an acceptable method of contraception. A woman is considered of childbearing potential if she is not surgically sterile or if her last menstrual period was \<12 months prior to Visit 1. Acceptable methods of contraception for this study include surgical sterilization, oral or depot contraceptives (taken for at least 60 days before Week 1), intrauterine devices, diaphragm with spermicide, or other methods on a subject-by-subject basis.
• Baseline EDSS score of 0.0-6.0 (average Week -1 and Week 1 pre-dose).
• Able to understand and be willing to comply with all study requirements, particularly the regimen for administration of investigational product.

You may not qualify if:

• Any subject who meets any of the following criteria will not qualify for entry into the study:
• A history of allergic reactions or drug hypersensitivity to honeybee venom.
• A systemic reaction to a skin test for hypersensitivity to Apitox. Phase 3 Trial Evaluating the Safety and Efficacy of Apitox Add-on Therapy Protocol 02-2014 for Improving Disability and Quality of Life in Patients with Multiple Sclerosis 07 April 2017
• History of abnormal MRI scan, not attributable to MS.
• Neurological disorder other than MS, acute or chronic infection.
• Malignant neoplasm or metastasis except for basal and squamous skin cancers.
• Coronary artery disease or prior myocardial infarction.
• Use of beta-blockers, drugs considered potent CYP450 inhibitors (see a list of moderate and strong CYP450 inhibitors in Appendix 9), alcohol, or preparations containing histamine (such as Prokarin™) during the study period.
• Insulin dependent diabetes mellitus or unstable type 2 diabetes mellitus.
• Any clinically significant ECG abnormalities (e.g. ischemic changes), as determined by the Investigator.
• Any abnormal clinical or laboratory parameter that is considered clinically significant or has Grade 3 or higher as specified in the "Guidance for Industry - Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers enrolled in Preventative Vaccine Clinical Trials" (Appendix 8). Subjects with abnormal hepatic and renal labs that are considered mild (Grade 1) or moderate (Grade 2) and not clinically significant (Appendix 8) will be monitored during the trial. 11. Recent (within 1 year of screening) alcohol abuse or use of marijuana or illicit drugs.
• \. Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the last dose of study drug.
• \. Females who are pregnant or who plan to become pregnant. 14. Use of an investigational product within a period of 28 days prior to enrollment in the study that would, in the opinion of the Investigator, confound the treatment for QoL or pain reduction.
• \. Any condition that, in the opinion of the Investigator, would place the subject at increased risk or may confound the study results. DOSAGE

Sponsors & Collaborators

• Apimeds, Inc.: lead

MeSH Terms

Conditions

Multiple Sclerosis; Pain

Interventions

Bee Venoms; Histamine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthropod Venoms; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators

Study Officials

• Robert Brooks, PhD

  Apimeds, Inc.

  STUDY DIRECTOR

Central Study Contacts

Robert Brooks, PhD

CONTACT

3027321358; dbrooks3@apimeds.com

Christopher M KIM, MD

CONTACT

3027321358; cmk@apimeds.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: randomization and blinded personnel at site
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1-1 in two studies of 468 patients total patients 936

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 18, 2018
• Study Start: April 1, 2019
• Primary Completion: August 1, 2019
• Study Completion: November 1, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-10