BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

NCT02230956 | Completed Phase 2 Results

• 2 other identifiers: 191622-1452014-001076-58
• Study Type: interventional
• Target: 176
• Locations: 3 countries
• Sites: 3

Brief Summary

This study will evaluate the efficacy and safety of a single intra-articular injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale

  Participants recorded the pain in their knee during the previous 24 hours in a daily diary where: 0=no pain to 10= worst pain possible. The daily pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.

  Baseline, Week 8

Secondary Outcomes (4)

• Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale

  Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

• Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale

  Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24

• Patient Global Impression of Change (GIC) Using a 7-Point Scale

  Weeks 1, 4, 8, 12, 16, 20 and 24

• Change From Baseline in the 7-Day Average Daily Worst Pain Score Using an 11-Point Scale

  Baseline, Week 24

Study Arms (3)

OnabotulinumtoxinA 400 U

EXPERIMENTAL

OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.

Biological: onabotulinumtoxinA

OnabotulinumtoxinA 200 U

EXPERIMENTAL

OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.

Biological: onabotulinumtoxinA

Placebo

PLACEBO COMPARATOR

Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.

Drug: Normal Saline

Interventions

onabotulinumtoxinA BIOLOGICAL

onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.

Also known as: botulinum toxin Type A, BOTOX®

OnabotulinumtoxinA 200 U; OnabotulinumtoxinA 400 U

Normal Saline DRUG

Normal Saline (placebo) injection into the intra-articular space of the study knee.

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Painful osteoarthritis
• Able to discontinue anti-inflammatory drugs and analgesics
• Must be ambulatory without assistive walking devices

You may not qualify if:

• Chronic pain conditions other than knee osteoarthritis
• Treatment with corticosteroids in the study knee within 12 weeks
• Treatment with hyaluronic acid in the study knee within 24 weeks
• Previous treatment with any botulinum toxin for any reason
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

Artesia, California, United States

Location

Unknown Facility

Pardubice, Czechia

Location

Unknown Facility

Vejle, Denmark

Location

Related Publications (1)

• McAlindon TE, Schmidt U, Bugarin D, Abrams S, Geib T, DeGryse RE, Kim K, Schnitzer TJ. Efficacy and safety of single-dose onabotulinumtoxinA in the treatment of symptoms of osteoarthritis of the knee: results of a placebo-controlled, double-blind study. Osteoarthritis Cartilage. 2018 Oct;26(10):1291-1299. doi: 10.1016/j.joca.2018.05.001. Epub 2018 May 9.

  PMID: 29753118 DERIVED

Related Links

• More Information

MeSH Terms

Conditions

Osteoarthritis

Interventions

Botulinum Toxins, Type A; Saline Solution

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 3, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 31, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-05

Locations

CZ (1); US (1); DK (1)