This is a non-GCP, randomized, masked, placebo-controlled study in client owned horses with a history of refractory navicular disease. The objective of this study is to evaluate the effectiveness and safety of an investigational veterinary product to control pain when administered perineurally to horses with refractory navicular disease or who are candidates for a neurectomy due to refractory navicular disease. Screening activities will take place at least 24 hours prior and up to 14 days in advance of treatment administration on Day 0. This 60-day study involves a one-time injectable treatment of investigational veterinary product administered to both forelimbs. An estimated 30 client-owned horses will be enrolled. After receiving treatment on Day 0, the horse will be required to either remain in the clinic until Day 3 or return to the study site on Days 3, 14, 28, and 60 for follow up evaluation visits. Owners will be required to report and record abnormal daily observations throughout the study. As necessary, the horse may return for additional evaluation during unscheduled visits.
The study is fully funded for the entire duration of the study. Study visits includes the initial study consultation, treatment Day 0, evaluation visits on Day 3, 14, 28, and 60. In addition to management of side effects that are thought to be directly related to participation in the study.
Horses are eligible if they meet the following inclusion criteria:
- Written informed owner consent has been obtained prior to screening procedures.
- The horse is at least 2 years old.
- In general good health or stabilized for chronic conditions as assessed by physical examination, medical history and clinical pathology evaluations.
- Lack of response to treatment of navicular disease and/ or owner considering neurectomy as treatment for chronic navicular disease.
- Unilateral or bilateral forelimb lameness of Grade 2, 3, or 4 using the AAEP Lameness Scale (0 to 5 scale).
- Positive response to anesthesia of the medial and lateral distal palmar digital nerves of the affected forelimbs.
- Radiographic evidence of degenerative changes associated with navicular disease (e.g. elevated number of or abnormally shaped lucent zones, subcortical stenosis, enthesophyte formation of the navicular bone) in one or both navicular bones.
Horses are not eligible if they meet the following exclusion criteria:
- Hindlimb lameness or lameness other than in the front hooves that could confound the lameness exams
- Horse is less than 2 years of age
- A change in shoeing or trimming within 2 weeks of enrollment. Shoeing and trimming are required to remain consistent throughout the study.
- Use of medications to treat navicular disease or drugs that could mask lameness (e.g. NSAIDs, isoxsuprine, steroids, clodronate (Osphos), tiludronic acid (Tildren)) within 2 weeks of starting the study
- Evidence of a neurectomy
- History of episodes of colic in the past 4 weeks preceding treatment with a novel therapy
- May be unavailable for the entire study duration or is felt to be unsuitable by the Investigator for any other reason
Additional study sites coming soon!
If you are interested in enrolling your pet or being an Investigator on this study, please contact ACI at https://www.animalci.com/contact/ or call (301) 841-0014.