Joint DiseasesPhase 2TOXARTNCT03726788
Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis
A Phase 2 study testing Botulinum Toxin Type A 100U, Botulinum Toxin Type A 200U and Triamcinolone Hexacetonide Inj Susp 20 MG/ML in people with Joint Diseases and Knee, run by Lille Catholic University at 1 site in France.
Trial summary
We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI). Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Joint Diseases, Knee, Therapeutics
- What is being tested?
- Botulinum Toxin Type A 100U, Botulinum Toxin Type A 200U and Triamcinolone Hexacetonide Inj Susp 20 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2019to Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Presenting gonarthrosis of degenerative origin, Kellgren/Lawrence Radiological Stage I to III, with a maturity of more than 18 months
- With pain intensity greater than or equal to 50/100 on an VAS
- In case of bilateral gonarthrosis, the VAS of the contralateral knee must be less than or equal to 30/100
- Presenting a failure of conventional per os treatments (non-steroidal anti-inflammatory drugs, analgesics)
- Affiliated with a social security scheme
- For women of childbearing age:
- effective contraception for the duration of the study
Who cannot join
- Patient presenting at the time of the inclusion visit: an inflammatory attack, septic or inflammatory arthritis, a generalized infectious episode in progress
- Local or regional local skin lesion
- Need of an arthroplasty within the next 12 months
- Having received corticosteroids or other molecules in intra-articular infiltration in the last 6 months
- History of traumatic knee injury (bone injury in the past 24 months), bone, ligament or meniscal surgery in the past 24 months
- History of disabling peripheral nerve injury
Show all 14Show fewer
- Severe bleeding disorders, anticoagulant treatment in progress or double antiplatelet aggregation
- BMI > 35 kg/m2
- Coxarthrosis with projected knee pain
- Pregnant or breastfeeding woman
- Patient under guardianship and protection of justice
- Allergy/contraindication to botulinum toxin type A, corticoids
- Usual contraindication to MRI
- Allergy to the contrast product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study
We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).
Read the detailed description
Knee osteoarthritis is one of the most common causes of joint pain and functional disability in the general population.
Intra-articular infiltrations of corticoids are indicated for painful crisis especially if accompanied of effusion. However, this effect lasts only 2 weeks.
Given the lack of effective long-term medical-infiltrative treatment, we believe that botulinum toxin type A could be used by its direct action on mediators of neuro-gene inflammation at the joint level and its indirect medullary action by retrograde migration.
To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis.
Dynamic Contrast Enhancement (DCE) Magnetic Resonance Imaging (MRI) demonstrated the correlation between synovial inflammation and pain in gonarthrosis in a cohort of 454 subjects. It has also made it possible, via the monitoring of synovial inflammation, to demonstrate the efficacy of treatments in patients suffering from rheumatoid arthritis in the early phase, juvenile chronic arthritis or osteoarthritis.
DCE MRI perfusion therefore appears here as the technique of choice to follow the evolution of synovial inflammation after botulinum toxin injection in patients with symptomatic gonarthrosis.
- Conditions
- Joint Diseases, Knee, Therapeutics, Magnetic Resonance Imaging
- Being tested
- Botulinum Toxin Type A 100U, Botulinum Toxin Type A 200U, Triamcinolone Hexacetonide Inj Susp 20 MG/ML
- Keywords
- knee, Arthrosis, Botulinum toxin, Magnetic Resonance Imaging
- Medical subject headings
- Joint Diseases, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A 100UDrug
Also called Botox 100 UNT Injection
one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI
Botulinum Toxin Type A 200UDrug
Also called Botox 200 UNT Injection
one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI
Triamcinolone Hexacetonide Inj Susp 20 MG/MLDrug
Also called HEXATRIONE
one intra-articular injection of 2 ml Triamcinolone Hexacetonide
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Type A 100U | Experimental | one intra-articular injection in the painful knee 30 days after the inclusion visit Receives: Drug: Botulinum Toxin Type A 100U |
| Botulinum Toxin Type A 200U | Experimental | one intra-articular injection in the painful knee 30 days after the inclusion visit Receives: Drug: Botulinum Toxin Type A 200U |
| Triamcinolone Hexacetonide 20 MG/ML | Active comparator | one intra-articular injection in the painful knee 30 days after the inclusion visit Receives: Drug: Triamcinolone Hexacetonide Inj Susp 20 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value
Measured: one month post-injection
Secondary outcomes (6)
Pain analysis by the visual analogue scale (VAS)
Evolution kinetics of daily pain collected during the first 3 months post-injection allowing to deduce the onset and duration of analgesic efficacy in number of days. The pain VAS is a continuous scale comprised of a horizontal line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: "no pain" (score of 0) and "pain as bad as it could be" (score of 100 [100-mm scale])
Measured: during the first 3 months after injection
Joint amplitude measured by goniometry
To measure range of motion of the knee
Measured: at 1, 3, 6 month post-injection
Western Ontario McMaster University Osteoarthritis (WOMAC) Index
An arthritic pain scoring system ranging from 0-no pain/disability to 100-most severe pain/disability
Measured: at 1, 3, 6 month post-injection
Two minutes walk
This test measure the distance walked in two minutes
Measured: at 1, 3, 6 month post-injection
Frequency of consumption of analgesics
Measured: at 1, 3, 6 month post-injection
Amount of consumption of analgesics
Measured: at 1, 3, 6 month post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startSep 2019 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionApr 2022 (estimated)
Why it stopped: discontinuation of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseasesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Hichem Khenioui, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726788
- Sponsor's protocol ID
- RC-P0037
- Acronym
- TOXART
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2018
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Antalgic Efficacy of an Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis by Perfusion MRI:a Superiority, Randomized, Controlled, Double Blind Study
- ClinicalTrials.gov ID
- NCT03726788
- Acronym / sponsor ID
- TOXART / RC-P0037
- Conditions
- Joint Diseases, Knee, Therapeutics, Magnetic Resonance Imaging
- Keywords
- knee, Arthrosis, Botulinum toxin, Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: discontinuation of the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Sep 2019 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We believe we can demonstrate a link between the analgesic action of intra-articular injection of botulinum toxin and synovial inflammation by Dynamic Contrast Enhancement (DCE) perfusion Magnetic Resonance Imaging (MRI).
Detailed description
Knee osteoarthritis is one of the most common causes of joint pain and functional disability in the general population.
Intra-articular infiltrations of corticoids are indicated for painful crisis especially if accompanied of effusion. However, this effect lasts only 2 weeks.
Given the lack of effective long-term medical-infiltrative treatment, we believe that botulinum toxin type A could be used by its direct action on mediators of neuro-gene inflammation at the joint level and its indirect medullary action by retrograde migration.
To date, 2 published randomized controlled trials and one unpublished Phase Ib clinical trial have shown that botulinum toxin injected intraarticularly improves pain and functionality in gonarthrosis.
Dynamic Contrast Enhancement (DCE) Magnetic Resonance Imaging (MRI) demonstrated the correlation between synovial inflammation and pain in gonarthrosis in a cohort of 454 subjects. It has also made it possible, via the monitoring of synovial inflammation, to demonstrate the efficacy of treatments in patients suffering from rheumatoid arthritis in the early phase, juvenile chronic arthritis or osteoarthritis.
DCE MRI perfusion therefore appears here as the technique of choice to follow the evolution of synovial inflammation after botulinum toxin injection in patients with symptomatic gonarthrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Type A 100U | Experimental | Drug: Botulinum Toxin Type A 100Uone intra-articular injection in the painful knee 30 days after the inclusion visit |
| Botulinum Toxin Type A 200U | Experimental | Drug: Botulinum Toxin Type A 200Uone intra-articular injection in the painful knee 30 days after the inclusion visit |
| Triamcinolone Hexacetonide 20 MG/ML | Active comparator | Drug: Triamcinolone Hexacetonide Inj Susp 20 MG/MLone intra-articular injection in the painful knee 30 days after the inclusion visit |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Presenting gonarthrosis of degenerative origin, Kellgren/Lawrence Radiological Stage I to III, with a maturity of more than 18 months
- With pain intensity greater than or equal to 50/100 on an VAS
- In case of bilateral gonarthrosis, the VAS of the contralateral knee must be less than or equal to 30/100
- Presenting a failure of conventional per os treatments (non-steroidal anti-inflammatory drugs, analgesics)
- Affiliated with a social security scheme
Key exclusion criteria (14 listed)
- Patient presenting at the time of the inclusion visit: an inflammatory attack, septic or inflammatory arthritis, a generalized infectious episode in progress
- Local or regional local skin lesion
- Need of an arthroplasty within the next 12 months
- Having received corticosteroids or other molecules in intra-articular infiltration in the last 6 months
- History of traumatic knee injury (bone injury in the past 24 months), bone, ligament or meniscal surgery in the past 24 months
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 A 100UAlso: Botox 100 UNT Injectionone intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI | Drug | Botulinum Toxin Type A 100U |
| Botulinum Toxin Type A 200UAlso: Botox 200 UNT Injectionone intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI | Drug | Botulinum Toxin Type A 200U |
| Triamcinolone Hexacetonide Inj Susp 20 MG/MLAlso: HEXATRIONEone intra-articular injection of 2 ml Triamcinolone Hexacetonide | Drug | Triamcinolone Hexacetonide 20 MG/ML |
Primary outcome
Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value
Time frame: one month post-injection
6 secondary outcomes
Pain analysis by the visual analogue scale (VAS)
Time frame: during the first 3 months after injection
Joint amplitude measured by goniometry
Time frame: at 1, 3, 6 month post-injection
Western Ontario McMaster University Osteoarthritis (WOMAC) Index
Time frame: at 1, 3, 6 month post-injection
Two minutes walk
Time frame: at 1, 3, 6 month post-injection
Frequency of consumption of analgesics
Time frame: at 1, 3, 6 month post-injection
Amount of consumption of analgesics
Time frame: at 1, 3, 6 month post-injection
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Joint Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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.
Hichem Khenioui, MD principal investigator
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Toxin Type A 100U, Botulinum Toxin Type A 200U and Triamcinolone Hexacetonide Inj Susp 20 MG/ML in people with Joint Diseases and Knee, run by Lille Catholic University at 1 site in France.
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 7 inclusion and 14 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: withdrawn, as of the sponsor's last update on 10 Sep 2025. 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 France. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assesment of vascularization by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) according to the % Area Under the Curve (AUC) of perfusion value (time frame: one month post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2025.