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

NCT01518257 | Completed Phase 1 Results

• 1 other identifier: 191622-102
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4

  The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.

  Baseline, Week 4

• Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8

  The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.

  Baseline, Week 8

• Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12

  The patient rated their daily worst pain intensity in the study knee using an 11-point scale where: 0=no pain to 10=worst pain possible. The daily scores over the previous 14-day period were averaged. A negative change from Baseline indicated improvement.

  Baseline, Week 12

Secondary Outcomes (4)

• Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score

  Baseline, Week 8

• Change From Baseline in WOMAC Pain Score

  Baseline, Week 8

• Change From Baseline in WOMAC Physical Function Score

  Baseline, Week 8

• Patient Global Impression of Change Score

  Week 8

Study Arms (2)

botulinum toxin Type A

EXPERIMENTAL

A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.

Biological: botulinum toxin Type A

Placebo

PLACEBO COMPARATOR

A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Drug: Normal Saline

Interventions

botulinum toxin Type A BIOLOGICAL

A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.

Also known as: BOTOX®

botulinum toxin Type A

Normal Saline DRUG

A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Aalborg, Denmark

Location

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 25, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: August 7, 2014
• Results First Posted: August 7, 2014

Record last verified: 2014-07

Locations

DK (1)