Efficacy and Tolerability of Novel A2A Agonist in Treatment of Diabetic Neuropathic Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and tolerability of BVT.115959 in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study.

Detailed Description
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The planned study is an exploratory study which aims to provide proof of the efficacy of BVT.115959 in the reduction of the symptoms of pain. Thus, the primary objective is to evaluate the anticipated analgesic properties of BVT.115959 in patients with diabetic neuropathic pain and to confirm its activity against placebo. The study will evaluate the efficacy and tolerability of oral BVT.115959 7 mg administered three times a day (t.i.d.) versus a matching placebo in diabetic patients with neuropathic pain who are either not on analgesia or are on stable analgesia in the month prior to entering the study and who are being maintained on stable analgesia throughout the study. Eligible subjects will be randomized in a ratio of 2:1 (BVT.115959: placebo). The study consists of a 1-week screening/baseline period, a 4-week treatment period and a 1 week follow-up period.

Official Title
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A Double-blind, Placebo-controlled, Randomized, Parallel-group Study Evaluating the Efficacy and Tolerability of Oral BVT.115959, a Novel A2A Agonist, Versus Placebo in the Treatment of Diabetic Neuropathic Pain

Conditions
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Diabetic Neuropathic Pain

Intervention / Treatment
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* Drug: BVT.115959
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of type 1 or 2 diabetes mellitus and documented painful, symmetrical, sensorimotor polyneuropathy for at least 6 months Either no analgesic medication or on stable analgesic medication for at least 4 weeks Exclusion Criteria: Female patients who are fertile and of child-bearing potential Clinically significant or unstable hepatic, respiratory, renal, hematologic, cardiovascular or peripheral vascular disease Painful conditions that may confound the evaluation of neuropathic pain

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BVT.115959<br>Capsules containing 7 mg BVT.115959 administered orally three times daily | Drug: BVT.115959<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules administered orally three times daily | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean 24-hour pain intensity score from baseline using an 11-point Likert NRS assessed over the preceding 24 hours immediately upon awakening in the morning |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Present pain intensity using an 11-point Likert NRS assessed at bedtime |  |  | 
| Short-Form McGill Pain Questionnaire parameters |  |  | 
| Weekly mean sleep interference score |  |  | 
| Clinical Global Impression of Change and Patient's Global Impression of Change |  |  | 
| Quality of life |  |  | 
| Mood stability |  |  | 
| Time to study withdrawal |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic neuropathy, painful, Adenosine A2A receptor