NCT02746068

Brief Summary

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
346

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2016

Longer than P75 for phase_3

Geographic Reach
2 countries

61 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

4.8 years

First QC Date

April 14, 2016

Last Update Submit

January 8, 2019

Conditions

Osteoarthritis, Knee

Keywords

Bone Marrow LesionsAXS02AxsomeKnee OAOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change in patient reported pain intensity

    Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible)

    Baseline to Week 24

Secondary Outcomes (3)

  • Patient Global Impression of Change (PGI-C)

    Week 12 and Week 24

  • Clinical Global Impression of Change (CGI-C) scores

    Week 12 and Week 24

  • Change in WOMAC pain and stiffness subscales over time

    Baseline to Week 24

Study Arms (2)

AXS-02

EXPERIMENTAL

Administered orally in the morning for 6 weeks

Drug: AXS-02

Placebo

PLACEBO COMPARATOR

Administered orally in the morning for 6 weeks

Drug: Placebo

Interventions

AXS-02DRUG
AXS-02
PlaceboDRUG
Placebo

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male at least 50 years of age, or postmenopausal female
  • Meets the ACR clinical criteria for knee osteoarthritis
  • Bone Marrow Lesion of the knee present on MRI
  • Additional criteria may apply

You may not qualify if:

  • Previous surgery on index knee
  • Any prior use of bisphosphonates within 6 months of screening
  • Additional criteria may apply

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (61)

Achieve Clinical Research

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Birmingham, Alabama, 35216, United States

Location

Unknown Facility

Chandler, Arizona, 85224, United States

Location

Unknown Facility

Phoenix, Arizona, 85023, United States

Location

Unknown Facility

Hot Springs, Arkansas, 71913, United States

Location

Unknown Facility

Anaheim, California, 92805, United States

Location

Unknown Facility

Canoga Park, California, 91303, United States

Location

Unknown Facility

El Cajon, California, 92020, United States

Location

Unknown Facility

La Mesa, California, 91941, United States

Location

Unknown Facility

Long Beach, California, 90806, United States

Location

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

North Hollywood, California, 91606, United States

Location

Unknown Facility

Sacramento, California, 95821, United States

Location

Unknown Facility

San Diego, California, 92103, United States

Location

Unknown Facility

Thousand Oaks, California, 91360, United States

Location

Unknown Facility

Upland, California, 91786, United States

Location

Unknown Facility

Denver, Colorado, 80230, United States

Location

Unknown Facility

Milford, Connecticut, 06460, United States

Location

Unknown Facility

Boynton Beach, Florida, 33472, United States

Location

Unknown Facility

Clearwater, Florida, 33756, United States

Location

Unknown Facility

Clermont, Florida, 34711, United States

Location

Unknown Facility

Hialeah, Florida, 33012, United States

Location

Unknown Facility

Jupiter, Florida, 33458, United States

Location

Unknown Facility

Lauderdale Lakes, Florida, 33319, United States

Location

Unknown Facility

Orlando, Florida, 32806, United States

Location

Accord Clinical Research

Port Orange, Florida, 32129, United States

Location

Unknown Facility

Port Saint Lucie, Florida, 34952, United States

Location

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Canton, Georgia, 30114, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Affinity Clinical Research Institute

Oak Lawn, Illinois, 60453, United States

Location

Unknown Facility

Oak Lawn, Illinois, 60453, United States

Location

Unknown Facility

Newton, Kansas, 67114, United States

Location

Unknown Facility

Wheaton, Maryland, 20902, United States

Location

Unknown Facility

Boston, Massachusetts, 02111, United States

Location

Unknown Facility

North Attleboro, Massachusetts, 02760, United States

Location

Unknown Facility

Quincy, Massachusetts, 02169, United States

Location

Unknown Facility

Kansas City, Missouri, 64114, United States

Location

Unknown Facility

St Louis, Missouri, 63042, United States

Location

Unknown Facility

Albuquerque, New Mexico, 87106, United States

Location

Unknown Facility

Hartsdale, New York, 10530, United States

Location

Unknown Facility

Rochester, New York, 14618, United States

Location

Unknown Facility

Charlotte, North Carolina, 28204, United States

Location

Unknown Facility

Raleigh, North Carolina, 27612, United States

Location

Unknown Facility

Cincinnati, Ohio, 45227, United States

Location

Unknown Facility

Duncansville, Pennsylvania, 16635, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Franklin, Tennessee, 37067, United States

Location

Unknown Facility

Austin, Texas, 78745, United States

Location

Unknown Facility

Baytown, Texas, 77521, United States

Location

Unknown Facility

DeSoto, Texas, 75115, United States

Location

Unknown Facility

Wichita Falls, Texas, 76309, United States

Location

Unknown Facility

Newport News, Virginia, 23606, United States

Location

Unknown Facility

Bellevue, Washington, 98007, United States

Location

Unknown Facility

Broadmeadow, New South Wales, 2292, Australia

Location

Unknown Facility

Noosa, Queensland, 4567, Australia

Location

Unknown Facility

Adelaide, South Australia, 5011, Australia

Location

Unknown Facility

Hobart, Tasmania, 7000, Australia

Location

Unknown Facility

Clayton, Victoria, 3168, Australia

Location

Unknown Facility

Melbourne, Victoria, 3004, Australia

Location

Unknown Facility

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2016

First Posted

April 21, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

AU(7)US(54)