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Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)

NCT01963611 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2016-05-11

Study results available
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Summary

This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for minimum treatment duration of 40 weeks.

Conditions

  • Relapsing Remitting Multiple Sclerosis

Interventions

DRUG

Plovamer acetate 0.5 milligram (mg)

Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

DRUG

Copaxone 20 mg

Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

DRUG

Plovamer acetate 3 mg

Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.

DRUG

Plovamer acetate 10 mg

Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.

DRUG

Plovamer acetate 20 mg

Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.

Sponsors & Collaborators

Principal Investigators

  • Medical Responsible · EMD Serono, Inc., Billerica MA, a subsidiary of Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Finland
  • Greece
  • Hungary
  • Italy
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT01963611 on ClinicalTrials.gov