Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03569098
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : May 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 Drug: abobotulinumtoxinA (Dysport) Drug: Placebo Phase 2

Layout table for study information
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 : January 14, 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.
Drug: abobotulinumtoxinA (Dysport)
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
  • 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.
Drug: abobotulinumtoxinA (Dysport)
Investigators will inject the reconstituted solution into foot muscles.
Other Names:
  • 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

  Show 31 Study Locations
Sponsors and Collaborators
Ipsen
Investigators
Layout table for investigator information
Study Director: Ipsen Medical Director Ipsen

Layout table for additonal information
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: May 30, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
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