OsteoarthritisPhase 2NCT02230956

BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis

A Phase 2 study testing onabotulinumtoxinA and Normal Saline in people with Osteoarthritis, run by Allergan at 3 sites in 3 countries.

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 injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Osteoarthritis
What is being tested?: onabotulinumtoxinA and Normal Saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 3 sitesin 3 countries
Study dates: Oct 2014to Mar 2016
Phase: Phase 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
Able to discontinue anti-inflammatory drugs and analgesics
Must be ambulatory without assistive walking devices

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

Country

City, postcode or hospital

3 sites in 3 countries

United States1 site

Study site
Artesia, California

Other trials in United States

Czechia1 site

Study site
Pardubice

Other trials in Czechia

Denmark1 site

Study site
Vejle

Other trials in Denmark

About this study

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
Being tested: onabotulinumtoxinA, 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.

onabotulinumtoxinABiological
Also called botulinum toxin Type A, BOTOX®
onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
Normal SalineDrug
Normal Saline (placebo) injection into the intra-articular space of the study knee.

Study groups in NCT02230956
Study group	Role	What they receive
OnabotulinumtoxinA 400 U	Experimental	OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1. Receives: Biological: onabotulinumtoxinA
OnabotulinumtoxinA 200 U	Experimental	OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1. Receives: Biological: onabotulinumtoxinA
Placebo	Placebo comparator	Placebo (Normal Saline) injection 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 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.
Measured: 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
The WOMAC Pain Score consisted of 5 questions about pain completed by the participant where: 0=no pain to 10=extreme pain for a total possible Pain Score of 0 (best) to 50 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
The WOMAC Physical Function Score consisted of 17 questions about the difficulty of daily activities completed by the participant where: 0=no difficulty to 10=extreme difficulty for a total possible Physical Function Score of 0 (best) to 170 (worst). A negative change from Baseline indicates improvement.
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Patient Global Impression of Change (GIC) Using a 7-Point Scale
The participant 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 indicate worsening and positive scores indicate improvement.
Measured: 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
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 worst pain scores over 7-days were averaged. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 24

Timeline

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

Oct 2014Mar 2016

First posted3 Sep 2014 (estimated)
Study startOct 2014
Primary completionMar 2016
Study completionMar 2016

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.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02230956
Sponsor's protocol ID: 191622-145
Other IDs: 2014-001076-58, 2014
Status last verified: May 2017
First submitted: 29 Aug 2014
Last updated: 31 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29753118

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 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
ClinicalTrials.gov ID: NCT02230956
Acronym / sponsor ID: 191622-145
Conditions: Osteoarthritis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 3 Sep 2014 (estimated)
Results: Posted 20 Apr 2017

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 injection of 2 doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee osteoarthritis symptoms.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
OnabotulinumtoxinA 400 U	Experimental	Biological: onabotulinumtoxinAOnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
OnabotulinumtoxinA 200 U	Experimental	Biological: onabotulinumtoxinAOnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
Placebo	Placebo comparator	Drug: Normal SalinePlacebo (Normal Saline) injection 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 (3 listed)

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

Key exclusion criteria (5 listed)

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

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
onabotulinumtoxinAAlso: botulinum toxin Type A, BOTOX®onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.	Biological	OnabotulinumtoxinA 200 U, OnabotulinumtoxinA 400 U
Normal SalineNormal Saline (placebo) injection into the intra-articular space of the study knee.	Drug	Placebo

Primary outcome

Change From Baseline in the 7-Day Average Daily Pain Score Using an 11-Point Scale
Time frame: Baseline, Week 8
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.

4 secondary outcomes

Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) Pain Score Using an 11-Point Scale
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Change From Baseline in the WOMAC™ Physical Function Score Using an 11-Point Scale
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20 and 24
Patient Global Impression of Change (GIC) Using a 7-Point Scale
Time frame: 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
Time frame: Baseline, Week 24

Results and safety

Results posted to the registry on 20 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OnabotulinumtoxinA 400 U	44	39
OnabotulinumtoxinA 200 U	43	37
Placebo	89	82

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

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

Measure	OnabotulinumtoxinA 400 U n = 44	OnabotulinumtoxinA 200 U n = 43	Placebo n = 89
Baseline	5.92 (1.222)	6.09 (1.313)	6.00 (1.150)
Change from Baseline at Week 8	-1.68 (1.641)	-2.07 (1.602)	-1.98 (1.793)

Population analysed: Safety population consisted of all randomized participants who received the study treatment and were analyzed by treatment actually received.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 172. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OnabotulinumtoxinA 400 U	6 of 44 (13.6%)	9 of 44 (20.5%)	Not reported
OnabotulinumtoxinA 200 U	4 of 43 (9.3%)	15 of 43 (34.9%)	Not reported
Placebo	6 of 89 (6.7%)	26 of 89 (29.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29753118McAlindon 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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
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Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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

3 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing onabotulinumtoxinA and Normal Saline in people with Osteoarthritis, run by Allergan at 3 sites in 3 countries.

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 3 inclusion and 5 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 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Czechia, 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 phase mean?

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 20 Apr 2017). 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 7-Day Average Daily Pain Score Using an 11-Point Scale (time frame: Baseline, Week 8). 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 NCT02230956, which also lists 1 linked publication.

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 31 May 2017.