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To Assess Effects of Arbaclofen ER Tablets Compared With Placebo on Sperm Parameters in Male Subjects With MS

NCT02869425 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2022-04-27

No results posted yet for this study

Summary

This study is designed to assess the effects of a therapeutic dose of arbaclofen extended release (ER) tablets compared with placebo on human sperm concentration, motility, and morphology in male subjects with multiple sclerosis (MS).

Conditions

Interventions

DRUG

arbaclofen ER Tablets

arbaclofen ER tablets, 10 mg, 15 mg, or 20 mg

DRUG

Placebo for arbaclofen ER tablets

matching placebo tablets to arbaclofen ER tablets 10 mg, 15 mg or 20 mg

Sponsors & Collaborators

  • Osmotica Pharmaceutical US LLC

    collaborator INDUSTRY

  • RVL Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sam Kaba, MD · Osmotica Pharmaceutical, VP - Global Clinical Development and Medical Affairs

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-10-31
Completion
2019-01-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02869425 on ClinicalTrials.gov