OsteoarthritisPhase 1/2NCT01518257

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

A Phase 1/2 study testing botulinum toxin Type A and Normal Saline in people with Osteoarthritis, run by Allergan at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis
What is being tested?: botulinum toxin Type A and Normal Saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 121 participants
Where: 1 siteDenmark
Study dates: Jan 2012to Jan 2013
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Study site
Aalborg

Other trials in Denmark

About this study

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
Being tested: botulinum toxin Type A, Normal Saline
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

botulinum toxin Type ABiological
Also called BOTOX®
A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
Normal SalineDrug
A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Study groups in NCT01518257
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 12

Secondary outcomes (4)

Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score
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.
Measured: Baseline, Week 8
Change From Baseline in WOMAC Pain Score
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.
Measured: Baseline, Week 8
Change From Baseline in WOMAC Physical Function Score
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.
Measured: Baseline, Week 8
Patient Global Impression of Change Score
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.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Jan 2013

First posted25 Jan 2012 (estimated)
Study startJan 2012
Primary completionJan 2013
Study completionJan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01518257
Sponsor's protocol ID: 191622-102
Status last verified: Jul 2014
First submitted: 23 Jan 2012
Last updated: 7 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of Botulinum Toxin Type A as Treatment for Osteoarthritis Knee Pain
ClinicalTrials.gov ID: NCT01518257
Acronym / sponsor ID: 191622-102
Conditions: Osteoarthritis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 25 Jan 2012 (estimated)
Results: Posted 7 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
botulinum toxin Type A	Experimental	Biological: botulinum toxin Type AA single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
Placebo	Placebo comparator	Drug: Normal SalineA single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
botulinum toxin Type AAlso: BOTOX®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
Normal SalineA single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.	Drug	Placebo

Primary outcome

Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4
Time frame: Baseline, 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.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8
Time frame: Baseline, 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.
Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12
Time frame: Baseline, 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.

4 secondary outcomes

Change From Baseline in Western Ontario and McMaster Universities Arthritis (WOMAC™) Total Index Score
Time frame: Baseline, Week 8
Change From Baseline in WOMAC Pain Score
Time frame: Baseline, Week 8
Change From Baseline in WOMAC Physical Function Score
Time frame: Baseline, Week 8
Patient Global Impression of Change Score
Time frame: Week 8

Results and safety

Results posted to the registry on 7 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Botulinum Toxin Type A	61	59
Placebo	60	60

Primary outcome: Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4

Time frame: Baseline, Week 4. Mean (Standard Deviation). Unit: Score on a scale

Measure	Botulinum Toxin Type A n = 61	Placebo n = 60
Baseline	6.4 (1.09)	6.5 (1.28)
Change from Baseline at Week 4	-1.8 (1.66)	-1.8 (1.87)

Population analysed: Safety population included all treated participants based on the actual treatment received.

Primary outcome: Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 8

Time frame: Baseline, Week 8. Mean (Standard Deviation). Unit: Score on a scale

Measure	Botulinum Toxin Type A n = 61	Placebo n = 60
Baseline	6.4 (1.09)	6.5 (1.28)
Change from Baseline at Week 8	-2.2 (1.96)	-2.3 (2.15)

Population analysed: Safety population included all treated participants based on the actual treatment received.

Primary outcome: Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 12

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: Score on a scale

Measure	Botulinum Toxin Type A n = 61	Placebo n = 60
Baseline	6.4 (1.09)	6.5 (1.28)
Change from Baseline at Week 12	-2.2 (1.97)	-2.5 (2.24)

Population analysed: Safety population included all treated participants based on the actual treatment received.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Botulinum Toxin Type A	1 of 61 (1.6%)	7 of 61 (11.5%)	Not reported
Placebo	0 of 60 (0%)	14 of 60 (23.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoarthritis

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing botulinum toxin Type A and Normal Saline in people with Osteoarthritis, run by Allergan at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Average Daily Worst Pain Intensity Score at Week 4 (time frame: Baseline, Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01518257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2014.