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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

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE June 26, 2018
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
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".
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
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
Change History Complete list of historical versions of study NCT03569098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2018)
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • 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, 8 and 12 (double blind period) and Day 1, Week 4, 8 and 12 (open label period) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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 averaged over the 7 consecutive days prior 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 PGI-S disability score averaged over the 7 consecutive days prior 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) ]
  • PGI-I foot pain 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 and Week 8 (open label period) ]
  • PGI-I disability 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 and Week 8 (open label period) ]
  • 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) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dysport in Hallux Abducto Valgus (HAV) Phase IIa
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hallux Abductovalgus
Intervention  ICMJE
  • 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)
  • Drug: Placebo
    Investigators will inject the reconstituted solution into foot muscles.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Botulinum toxin type A
  • 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.
    Intervention: Biological: Botulinum toxin type A
  • Placebo Comparator: Placebo
    Intramuscular injection of Placebo on day 1 of cycle 1 (double-blind period)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
165
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 23, 2020
Estimated Primary Completion Date February 3, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03569098
Other Study ID Numbers  ICMJE D-FR-52120-237
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ipsen
Study Sponsor  ICMJE Ipsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ipsen Medical Director Ipsen
PRS Account Ipsen
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP