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Dysport in Hallux Abducto Valgus (HAV) Phase IIa (DYSTANCE)

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ClinicalTrials.gov Identifier: NCT03569098
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 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
Estimated Primary Completion Date : February 3, 2020
Estimated Study Completion Date : June 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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.
Biological: Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
  • AbobotulinumtoxinA (Dysport®)
  • Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC)

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.
Biological: Botulinum toxin type A
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
  • AbobotulinumtoxinA (Dysport®)
  • Clostridium botulinum toxin type A haemagglutinin complex (BTX-A-HAC)

Placebo Comparator: Placebo
Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
Drug: Placebo
Investigators will inject the reconstituted solution into foot muscles.




Primary Outcome Measures :
  1. 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 :
  1. 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".

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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) ]
  7. 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) ]
  8. Time to retreatment [ Time Frame: Up to 24 weeks ]
  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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) ]


Information from the National Library of Medicine

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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


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

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Locations
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United States, Arkansas
NEA Baptist Clinic Recruiting
Jonesboro, Arkansas, United States, 72401
Applied Research Center of Arkansas, Inc Recruiting
Little Rock, Arkansas, United States, 72212
United States, California
Center for Clinical Research Inc. Withdrawn
Carmichael, California, United States, 95608
Center for Clinical Research Inc. Active, not recruiting
Castro Valley, California, United States, 94546
Limb Preservation Platform, Inc. Active, not recruiting
Fresno, California, United States, 93710
Southwestern Academic Limb Salvage Alliance Recruiting
Los Angeles, California, United States, 90033
Foot and Ankle Clinic Active, not recruiting
Los Angeles, California, United States, 90057
University Foot and Ankle Institute Active, not recruiting
Santa Monica, California, United States, 90403
United States, Colorado
Animas Foot and Ankle Withdrawn
Durango, Colorado, United States, 81301
Center for Spine and Orthopedics Active, not recruiting
Thornton, Colorado, United States, 80229
United States, Florida
LCC Medical Research Institute Recruiting
Miami, Florida, United States, 33126
Conquest Research Recruiting
Orlando, Florida, United States, 32822
Doctors Research Network Recruiting
South Miami, Florida, United States, 33301
Clinical Research Active, not recruiting
West Palm Beach, Florida, United States, 33406
United States, Illinois
Podiatry 1st Recruiting
Belleville, Illinois, United States, 62226
Weil Foot & Ankle Institute Recruiting
Des Plaines, Illinois, United States, 60016
Rosalind Franklin Clinic Active, not recruiting
North Chicago, Illinois, United States, 60064
Foot and Ankle Center of Illinois Active, not recruiting
Springfield, Illinois, United States, 62704
United States, Maryland
The Chesapeake Research Group Active, not recruiting
Pasadena, Maryland, United States, 21122
United States, Missouri
Dr. Allen M. Jacobs and Associates Active, not recruiting
Saint Louis, Missouri, United States, 63117
United States, Ohio
Ankle and Foot Care Centers Recruiting
Youngstown, Ohio, United States, 22801
United States, Oklahoma
Medical Research International Active, not recruiting
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
Foot and Ankle Center Active, not recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Harrisburg Foot and Ankle Center, INC Active, not recruiting
Harrisburg, Pennsylvania, United States, 17112
United States, Texas
Futuro Clinical Trials, LLC Active, not recruiting
McAllen, Texas, United States, 78501
Bio X Cell Research Recruiting
San Antonio, Texas, United States, 78229
Texas Gulf Coast Medical Group Recruiting
Webster, Texas, United States, 77598
United States, Utah
Summit Foot & Ankle Active, not recruiting
Salt Lake City, Utah, United States, 84117
United States, Virginia
Harrisonburg Foot and Ankle Clinic Recruiting
Harrisonburg, Virginia, United States, 22801
1Foot 2Foot Centre for Foot and Ankle Care, PC Recruiting
Suffolk, Virginia, United States, 23434
United States, West Virginia
Martinsville Research Institute, Inc. Active, not recruiting
Salem, West Virginia, United States, 24153
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03569098     History of Changes
Other Study ID Numbers: D-FR-52120-237
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019

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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
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