Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Apitox Add-on Therapy for Improving Disability and QOL in MS Patients

NCT03710655 Phase 3 UNKNOWN

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

Details

Lead sponsor	Apimeds, Inc.
Phase	Phase 3
Status	UNKNOWN
Enrolment	468
Start date	2019-04
Completion	2019-11

Conditions

• Multiple Sclerosis

Interventions

• Apitox - pure honeybee toxin
• Placebo

Primary outcomes

• Expanded Disability Status Scale (EDSS) — 16 weeks
• MS Functional Composite (MSFC) — 16 weeks