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Trial record 99 of 724 for:    Botulinum Toxins, Type A

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

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ClinicalTrials.gov Identifier: NCT01518257
Recruitment Status : Completed
First Posted : January 25, 2012
Results First Posted : August 7, 2014
Last Update Posted : August 7, 2014
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Biological: botulinum toxin Type A
Drug: Normal Saline
Enrollment 121
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Period Title: Overall Study
Started 61 60
Completed 59 60
Not Completed 2 0
Reason Not Completed
Lost to Follow-up             1             0
Other Miscellaneous Reason             1             0
Arm/Group Title Botulinum Toxin Type A Placebo Total
Hide Arm/Group Description A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 61 60 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
40 to 64 Years 30 31 61
≥ 65 Years 31 29 60
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 60 participants 121 participants
Female
32
  52.5%
30
  50.0%
62
  51.2%
Male
29
  47.5%
30
  50.0%
59
  48.8%
1.Primary Outcome
Title Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4
Hide Description 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.
Time Frame Baseline, Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 6.4  (1.09) 6.5  (1.28)
Change from Baseline at Week 4 -1.8  (1.66) -1.8  (1.87)
2.Primary Outcome
Title Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8
Hide Description 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.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 6.4  (1.09) 6.5  (1.28)
Change from Baseline at Week 8 -2.2  (1.96) -2.3  (2.15)
3.Primary Outcome
Title Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 6.4  (1.09) 6.5  (1.28)
Change from Baseline at Week 12 -2.2  (1.97) -2.5  (2.24)
4.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score
Hide Description The WOMAC Total Index Score consisted of 24 components rated on a scale of 0 to 10. The Total Index Score included the WOMAC Pain Score (5 questions about pain where: 0=no pain to 10=extreme pain), the WOMAC Physical Function score (17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty) and the WOMAC Stiffness Score (2 questions about stiffness where: 0=no stiffness to 10=extreme stiffness) for a total possible Index Score of 0 (best) to 240 (worst). A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 104.5  (36.53) 107.6  (37.44)
Change from Baseline at Week 8 (n=59,59) -46.5  (35.21) -43.8  (47.25)
5.Secondary Outcome
Title Change From Baseline in WOMAC Pain Score
Hide Description The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 23.9  (6.76) 24.3  (7.01)
Change from Baseline at Week 8 (n=59,59) -10.7  (7.27) -11.0  (9.75)
6.Secondary Outcome
Title Change From Baseline in WOMAC Physical Function Score
Hide Description The WOMAC Physical Function Score included 17 questions about the difficulty of daily activities where: 0=no difficulty to 10=extreme difficulty for a total possible score of 0 (best) to 170 (worst). A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all treated participants based on the actual treatment received.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 61 60
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 71.0  (28.43) 73.3  (29.77)
Change from Baseline at Week 8 (n=59,59 ) -31.7  (26.41) -28.6  (35.26)
7.Secondary Outcome
Title Patient Global Impression of Change Score
Hide Description The participants rated the change in their health status since enrollment using a 7-point scale where: +3=very much improved, +2=much improved, +1=minimally improved, 0=no change, -1=minimally worse, -2=much worse and -3=very much worse. Negative scores indicated worsening and positive scores indicated improvement.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety population (all treated participants based on the actual treatment received) with data available for this outcome measure.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 59 59
Mean (Standard Deviation)
Unit of Measure: Score on a scale
1.3  (1.28) 1.0  (1.38)
8.Post-Hoc Outcome
Title Change From Baseline in the Average Daily Worst Pain Intensity Score in the Nociceptive Pain Group
Hide Description 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.
Time Frame Baseline, Weeks 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 6.4  (1.01) 6.4  (1.35)
Change from Baseline at Week 4 -1.9  (1.56) -1.5  (1.58)
Change from Baseline at Week 8 -2.6  (2.01) -1.8  (2.01)
Change from Baseline at Week 12 -2.6  (1.79) -2.0  (2.27)
9.Post-Hoc Outcome
Title Change From Baseline in WOMAC Pain Score in the Nociceptive Pain Group
Hide Description The WOMAC Pain Score included 5 questions about pain where: 0=no pain to 10=extreme pain for a total possible score of 0 (best) to 50 (worst). A negative change from Baseline indicated improvement.
Time Frame Baseline, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety population (all treated participants based on the actual treatment received) in a subgroup of patients with nociceptive pain (pain that is caused by nerves that react to injury or damage) at Baseline.
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description:
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 22.7  (5.95) 22.9  (6.98)
Change from Baseline at Week 8 (n=35,31) -11.0  (7.09) -7.5  (9.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Botulinum Toxin Type A Placebo
Hide Arm/Group Description A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
All-Cause Mortality
Botulinum Toxin Type A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Botulinum Toxin Type A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/61 (1.64%)   0/60 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  1/61 (1.64%)  0/60 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Botulinum Toxin Type A Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   7/61 (11.48%)   14/60 (23.33%) 
Infections and infestations     
Nasopharyngitis  1  1/61 (1.64%)  5/60 (8.33%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  3/61 (4.92%)  5/60 (8.33%) 
Arthralgia * 1  3/61 (4.92%)  4/60 (6.67%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01518257     History of Changes
Other Study ID Numbers: 191622-102
First Submitted: January 23, 2012
First Posted: January 25, 2012
Results First Submitted: July 15, 2014
Results First Posted: August 7, 2014
Last Update Posted: August 7, 2014