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Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01518257
First received: January 23, 2012
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
  Purpose

This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.


Condition Intervention Phase
Osteoarthritis
 Biological: botulinum toxin Type A
Drug: Normal Saline
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox Osteoarthritis
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Daily Worst Pain Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Western Ontario McMaster Arthritis Index (WOMAC™) Total Index Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WOMAC Pain Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in WOMAC Physical Function Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient Global Impression of Change Score [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin Type A
A single 200 U (2 mL) dose of botulinum toxin Type A will be injected into the intra-articular space of the study knee on Day 1.
 Biological: botulinum toxin Type A
A single 200 U (2 mL) dose of botulinum toxin Type A will be injected into the intra-articular space of the study knee on Day 1.
Other Name: BOTOX®
Placebo Comparator: Placebo
A single 2 mL dose of Normal Saline (placebo) will be injected into the intra-articular space of the study knee on Day 1.
 Drug: Normal Saline
A single 2 mL dose of Normal Saline (placebo) will be injected into the intra-articular space of the study knee on Day 1.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Painful osteoarthritis in the study knee
  • Able to walk without assistive walking devices, able to perform usual daily activities, and agree to maintain similar activity level throughout the study

Exclusion Criteria:

  • Chronic pain conditions other than knee osteoarthritis
  • Presence of bursitis, meniscus tear, ligament tear, or significant injury to the study knee within 1 year
  • Surgery to the study knee within 24 weeks
  • Treatment with hyaluronic acid in the study knee within 24 weeks
  • Treatment with corticosteroids in the study knee within 12 weeks
  • Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
  • Previous treatment with botulinum toxin of any serotype for any reason
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518257

Locations
Denmark
Aalborg, Denmark
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01518257     History of Changes
Other Study ID Numbers: 191622-102
Study First Received: January 23, 2012
Last Updated: February 8, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Botulinum Toxins, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013