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

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apimeds, Inc.
• Treatments: Histamine

Criteria

Inclusion Criteria:

• Subjects who have provided written informed consent and authorization for disclosure of protected health information must meet the following criteria:

1. Men or women aged 18 to 65 years inclusive.

2. Confirmed diagnosis of MS as defined by the McDonald criteria [25].

3. 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).

4. 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.

5. Baseline EDSS score of 0.0-6.0 (average Week -1 and Week 1 pre-dose).

6. Able to understand and be willing to comply with all study requirements, particularly the regimen for administration of investigational product.

Exclusion Criteria:

• Any subject who meets any of the following criteria will not qualify for entry into the study:

1. A history of allergic reactions or drug hypersensitivity to honeybee venom.

2. 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

3. History of abnormal MRI scan, not attributable to MS.

4. Neurological disorder other than MS, acute or chronic infection.

5. Malignant neoplasm or metastasis except for basal and squamous skin cancers.

6. Coronary artery disease or prior myocardial infarction.

7. 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.

8. Insulin dependent diabetes mellitus or unstable type 2 diabetes mellitus.

9. Any clinically significant ECG abnormalities (e.g. ischemic changes), as determined by the Investigator.

10. 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.

12. Females who are lactating/breastfeeding or who plan to breastfeed while on study through 2 weeks after receiving the last dose of study drug.

13. 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.

15. Any condition that, in the opinion of the Investigator, would place the subject at increased risk or may confound the study results. DOSAGE