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
Last Update Posted : July 28, 2020
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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 Abductovalgus | 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Bunion
MedlinePlus related topics:
Botox
| 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 :
- Change from baseline in the daily Numeric Pain Rating Scale (NPRS) score [ Time Frame: Change from baseline to Week 8 (double blind period) ]The daily NPRS score averaged over the 7 consecutive days prior to baseline and Week 8. The NPRS is based on an 11-point scale ranging from 0 to 10, where 0 equals "no pain" and 10 equals "worst possible pain".
Secondary Outcome Measures :
- Change from baseline in the daily NPRS score averaged over the 7 consecutive days prior to each scheduled assessment timepoint (except Week 8 DB) [ Time Frame: Change from baseline to Week 4 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]The NPRS is based on an 11-point scale ranging from 0 to 10, where 0 equals "no pain" and 10 equals "worst possible pain".
- Change from baseline in the daily modified Foot Function Index (mFFI) disability subscale score averaged over the 7 consecutive days prior to each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]mFFI items are rated using numeric rating scales ranging from 0 to 10 and cover a period of the 'past' 24 hours. The poles are labelled "no pain" and "worst pain imaginable" (pain), "no difficulty" and "so difficult unable" (disability), and "none of the time" and "all of the time" (limitations). For each item, the subject is asked to record the number value which best corresponds to the effect of the foot complaints.
- Change from baseline in the daily mFFI pain subscale score averaged over the 7 consecutive days prior to each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]mFFI items are rated using numeric rating scales ranging from 0 to 10 and cover a period of the 'past' 24 hours. The poles are labelled "no pain" and "worst pain imaginable" (pain), "no difficulty" and "so difficult unable" (disability), and "none of the time" and "all of the time" (limitations). For each item, the subject is asked to record the number value which best corresponds to the effect of the foot complaints.
- Change from baseline in the daily mFFI total score averaged over the 7 consecutive days prior to each scheduled assessment timepoint. [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]mFFI items are rated using numeric rating scales ranging from 0 to 10 and cover a period of the 'past' 24 hours. The poles are labelled "no pain" and "worst pain imaginable" (pain), "no difficulty" and "so difficult unable" (disability), and "none of the time" and "all of the time" (limitations). For each item, the subject is asked to record the number value which best corresponds to the effect of the foot complaints.
- Change from baseline in the daily mFFI activity limitation subscale score averaged over the 7 consecutive days prior to each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]mFFI items are rated using numeric rating scales ranging from 0 to 10 and cover a period of the 'past' 24 hours. The poles are labelled "no pain" and "worst pain imaginable" (pain), "no difficulty" and "so difficult unable" (disability), and "none of the time" and "all of the time" (limitations). For each item, the subject is asked to record the number value which best corresponds to the effect of the foot complaints.
- Change from baseline in Hallux angular measurements (HV) angle as measured directly by weight-bearing anterior-posterior radiographs at each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]
- Change from baseline in intermetatarsal angle as measured directly by weight-bearing anterior-posterior radiographs at each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4 and 12 (open label period) ]
- Time to retreatment [ Time Frame: Up to 24 weeks ]
- Change from baseline in Patient Global Impression of Severity (PGI-S) of foot pain score at each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]Assessment of PGI-S of foot pain will be conducted by the subject using a 4-point Likert scale (from 0: no pain to 3: severe pain).
- Change from baseline in PGI-S disability score at each scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1 and Week 8 (open label period) ]Assessment of PGI-S of foot pain will be conducted by the subject using a 4-point Likert scale (from 0: no pain to 3: severe pain).
- Patient Global Impression of Improvement (PGI-I) of foot pain score at the scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1 and Week 8 (open label period) ]Assessment of PGI-I of foot pain will be conducted by the subject using a 7-point Likert scale (from -3: very much worse to +3: very much improved).
- PGI-I disability score at the scheduled assessment timepoint [ Time Frame: Change from baseline to Week 4, 8 and 12 (double blind period) and Day 1 and Week 8 (open label period) ]Assessment of PGI-I of foot pain will be conducted by the subject using a 7-point Likert scale (from -3: very much worse to +3: very much improved).
- Change from baseline in functional outcome as measured by the 36 item short form survey (SF-36) at each scheduled assessment timepoint [ Time Frame: Baseline, Week 8 and 12 (double blind period) and Day 1, Week 8 and 12 (open label period) ]
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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
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Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Ipsen Medical Director | Ipsen |
| Responsible Party: | Ipsen |
| ClinicalTrials.gov Identifier: | NCT03569098 |
| Other Study ID Numbers: |
D-FR-52120-237 |
| First Posted: | June 26, 2018 Key Record Dates |
| Last Update Posted: | July 28, 2020 |
| Last Verified: | July 2020 |
| 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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Hallux Valgus Foot Deformities Musculoskeletal Diseases 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 |