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An Efficacy and Safety Study of Palovarotene for the Treatment of MO

NCT03442985 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2022-08-01

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled study comparing the safety and efficacy of 2 dosage regimens of palovarotene versus placebo in preventing disease progression in pediatric subjects with multiple osteochondromas (MO).

Conditions

  • Exostoses, Multiple Hereditary

Interventions

DRUG

Palovarotene 2.5 mg

Subjects received a weight-adjusted dose equivalent of 2.5 mg palovarotene, once daily, for up to 24 months.

DRUG

Palovarotene 5.0 mg

Subjects received a weight-adjusted dose equivalent of 5.0 mg palovarotene, once daily, for up to 24 months.

OTHER

Placebo

Subjects received placebo, once daily, for up to 24 months.

Sponsors & Collaborators

  • Clementia Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2020-03-24
Completion
2020-10-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Italy
  • Japan
  • Netherlands
  • Portugal
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT03442985 on ClinicalTrials.gov