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Trial record 9 of 720 for:    Botulinum Toxins, Type A

DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02973269
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Wake Forest University Health Sciences
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Brief Summary:
The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Biological: Botulinum Toxins, Type A Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Arm Intervention/treatment
Experimental: DaxibotulinumtoxinA 240 units
Botulinum Toxins, Type A Intramuscular injection
Biological: Botulinum Toxins, Type A
Intramuscular injection
Other Name: DaxibotulinumtoxinA

Placebo Comparator: Placebo
Placebo Intramuscular injection
Biological: Placebo
Intramuscular injection




Primary Outcome Measures :
  1. Improvement in the American Orthopaedic Foot and Ankle Score (AOFAS) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Reduction in the visual analog pain score for the foot [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent, including authorization to release health information
  • Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis
  • Persistent heel pain for more than three months
  • Women of child bearing potential must have a negative urine pregnancy test (UPT) at Screening Visit and must use an effective method of birth control during the course of the study

Exclusion Criteria:

  • Previous surgery on the midfoot or hindfoot
  • Neuromuscular disease
  • Systemic muscle weakness
  • Planning a pregnancy during the study
  • Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit

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): NCT02973269


Locations
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United States, North Carolina
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Revance Therapeutics, Inc.
Wake Forest University Health Sciences

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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02973269     History of Changes
Other Study ID Numbers: RT002-CL008
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
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