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Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

NCT03547206 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-10-12

No results posted yet for this study

Summary

This study is designed as a double-masked, randomized, placebo-controlled, clinical study to evaluate the efficacy and safety of subcutaneous (SC) administration of RPh201 in participants with previous NAION. All participants enrolled in Cohort A of the study will have a documented history of NAION for at least 12 months and at most, five years prior to enrollment. Participants enrolled in Cohort B of the study will have a documented history of NAION for at least 6 months and at most, three years prior to enrollment.

Conditions

Interventions

DRUG

RPh201 Cohort A

RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).

OTHER

Placebo Cohort A

The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).

DRUG

RPh201 Cohort B

RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).

OTHER

Placebo Cohort B

The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).

Sponsors & Collaborators

  • Regenera Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Leonard A Levin, M.D., Ph.D. · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2020-09-27
Completion
2020-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03547206 on ClinicalTrials.gov