Dysport in Hallux Abducto Valgus (HAV) Phase IIa (DYSTANCE)
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| ClinicalTrials.gov Identifier: NCT03569098 |
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Recruitment Status :
Completed
First Posted : June 26, 2018
Results First Posted : July 2, 2021
Last Update Posted : July 2, 2021
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Sponsor:
Ipsen
Information provided by (Responsible Party):
Ipsen
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Brief Summary:
The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hallux Abducto Valgus | Biological: Botulinum toxin type A Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 186 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multiple-dose, Double-blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dysport for the Treatment of Pain Associated With Hallux Abducto Valgus |
| Actual Study Start Date : | June 19, 2018 |
| Actual Primary Completion Date : | December 17, 2019 |
| Actual Study Completion Date : | May 22, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dysport Dose 1
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
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Biological: Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
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Experimental: Dysport Dose 2
Intramuscular injection of Dysport on day 1 of double-blind period, followed by up to 2 open-label injections during open-label cycles, during approximately 36 weeks.
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Biological: Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
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Placebo Comparator: Placebo
Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
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Drug: Placebo
Investigators will inject the reconstituted solution into foot muscles. |
Primary Outcome Measures :
- Least Square (LS) Mean Change From Baseline in the Daily Numeric Pain Rating Scale (NPRS) Score at Week 8 [ Time Frame: Baseline and Week 8 in the double-blind treatment period ]The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an electronic diary (eDiary) for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1).
Secondary Outcome Measures :
- LS Mean Change From Baseline in the Daily NPRS Score at Weeks 4 and 12 [ Time Frame: Baseline and Weeks 4 and 12 in the double-blind treatment period ]The NPRS is a widely used and validated unidimensional measure of pain intensity in adults. Participants were asked to rate the intensity of their foot pain during physical activity (example, walking, standing or running) based on an 11-point scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". Higher scores indicate a worse outcome. Daily pain intensities were recorded by the participant using an eDiary for 7 consecutive days prior to each study visit. Baseline was defined as the daily NPRS score averaged over the 7 consecutive days prior to the Baseline visit (Day 1).
- LS Mean Change From Baseline in the Daily Modified Foot Function Index (mFFI) Disability Subscale Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The foot function index (FFI) was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI disability subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "no difficulty" and 10 represents "so difficult unable to do". For each item, the participant was asked to record the number value which best corresponded to effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
- LS Mean Change From Baseline in the Daily mFFI Pain Subscale Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI pain subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "no pain" and 10 represents "worst pain imaginable". For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
- LS Mean Change From Baseline in the Daily mFFI Total Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into three subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI items are rated using numeric rating scales ranging from 0 to 10, where 0 represents "no pain/no difficulty/none of the time" and 10 represents "worst pain imaginable/so difficult unable to do/all of the time" for pain, disability and activity limitation subscales, respectively. For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a total score, the scores of all 3 subscales were totaled and divided by 3. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
- LS Mean Change From Baseline in the Daily mFFI Activity Limitation Subscale Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The FFI was developed to assess foot-related pain, disability and activity limitations and later revised to include foot-related health and quality of life. A modified version of the FFI specific to this study was used. The mFFI consists of a total of 21 items grouped into 3 subscales: pain (7 questions), disability (9 questions) and activity limitation (5 questions). The mFFI activity limitation subscale is rated using numeric rating scale ranging from 0 to 10, where 0 represents "none of the time" and 10 represents "all of the time". For each item, the participant was asked to record the number value which best corresponded to the effect of the foot complaints. To obtain a subscale score, the item scores for a given subscale (i.e., pain, disability or activity limitation subscales) were totaled and divided by the maximum total possible and then multiplied by 100. Each subscale score, as well as the total score, ranged from 0 to 100. Higher scores indicate a worse outcome.
- LS Mean Change From Baseline in HV Angle at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The HV angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 centimeters (cm).
- LS Mean Change From Baseline in Intermetatarsal Angle at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]The intermetatarsal angle was measured directly on weight-bearing anteriorposterior radiographs, in which the X-ray beam was angled 15° towards the heel centered on the second tarsometatarsal joint with a source to image-receptor distance of 100 cm.
- Median Time to Retreatment [ Time Frame: Up to 24 weeks in the double-blind treatment period ]Time to retreatment was calculated as ([Date of retreatment - previous injection date] + 1) / 7 (week). Time to retreatment was calculated for each cycle and the data presented here for the double-blind treatment period.
- LS Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) of Foot Pain Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]An assessment of PGI-S of foot pain was conducted by the participant using a 4-point Likert scale ranging from 0= no pain to 3= severe pain. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: "How severe was your foot pain while performing physical activities (example, standing, walking or running) over the past week?" (0=no pain; 1=mild pain; 2=moderate pain; 3=severe pain).
- LS Mean Change From Baseline in PGI-S of Disability Score at Weeks 4, 8 and 12 [ Time Frame: Baseline and Weeks 4, 8 and 12 in the double-blind treatment period ]An assessment of PGI-S of disability was conducted by the participant using a 4-point Likert scale ranging from 0= no disability to 3= severe disability. Higher scores indicate a worse outcome. The PGI-S was assessed by the participant by answering the following question: "How severe was your disability while performing physical activities (example, standing, walking or running) over the past week?" (0=no disability; 1=mild disability; 2=moderate disability; 3=severe disability).
- LS Mean Patient Global Impression of Improvement (PGI-I) of Foot Pain Score at Weeks 4, 8 and 12 [ Time Frame: Weeks 4, 8 and 12 in the double-blind treatment period ]An assessment of PGI-I of foot pain was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: "Compared to your foot pain prior to the study treatment initiation, your foot pain while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse".
- LS Mean PGI-I of Disability Score at Weeks 4, 8 and 12 [ Time Frame: Weeks 4, 8 and 12 in the double-blind treatment period ]An assessment of PGI-I of the participant's disability was conducted by the participant using a 7-point Likert scale ranging from -3= very much worse to +3= very much improved. Higher scores indicate a better outcome. The PGI-I was assessed by the participant answering the following question: "Compared to your disability prior to the study treatment initiation, your disability while performing physical activities (example, standing, walking or running) now is: +3=very much improved; +2=much improved; +1=minimally improved; 0=no change; -1=minimally worse; -2=much worse; -3=very much worse".
- Mean Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Weeks 8 and 12 [ Time Frame: Baseline and Weeks 8 and 12 in the double-blind treatment period ]The SF-36 is a 36-item questionnaire which measures the extent to which physical health impacts an individual's functional ability and perceived wellbeing in mental, social, and physical aspects of life. The SF-36 has 8 subscales: physical function, role physical, bodily pain, global health, vitality, social function, role emotional and mental health. Each scale ranges from 0-100, where 0= lowest level of health and 100= highest level of health. Scores on these subscales can be aggregated into the physical component summary (physical function, role physical, bodily pain and global health) and mental component summary (mental health, vitality, social function and role emotional). Physical component summary score ranges from 0.65 to 80.73 and mental component summary score ranges from -8.81 to 81.65, where low score indicates lowest level of health and high score indicates highest level of health. Positive change from Baseline indicates an improvement in quality of life.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of HAV
- Painful HAV in the study foot at Baseline
Exclusion Criteria:
- Flat or square metatarsal head, metatarsus primus elevates, or severe cavus/planus in the study foot
- Other podiatric or orthopedic condition which would interfere with the evaluation of pain and/or function
- Medical history or clinical evidence of any vascular disease and/or diabetic condition
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03569098
Locations
Show 29 study locations
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
Study Documents (Full-Text)
Documents provided by Ipsen:
Documents provided by Ipsen:
Study Protocol [PDF] July 3, 2019
Statistical Analysis Plan [PDF] September 20, 2019
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT03569098 |
| Other Study ID Numbers: |
D-FR-52120-237 |
| First Posted: | June 26, 2018 Key Record Dates |
| Results First Posted: | July 2, 2021 |
| Last Update Posted: | July 2, 2021 |
| Last Verified: | July 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA Hemagglutinins Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents Agglutinins Immunologic Factors |