AZD2066 Neuropathic Pain - Mechanical Hypersensitivity

Study Overview
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Brief Summary
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The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.

Official Title
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A Phase IIa, Double-Blind, Randomised, Parallel-Group, Multi-Centre Study to Evaluate the Analgesic Efficacy of 28 Days Oral Administration of AZD2066 Compared to Placebo in Peripheral Neuropathic Pain Patients With Mechanical Hypersensitivity

Conditions
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Neuropathic Pain, Mechanical Hypersensitivity

Intervention / Treatment
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* Drug: AZD2066
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Male or non-fertile females Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia. Exclusion Criteria: Other pain that may confound assessment of neuropathic pain. Diagnosis of any severe neurological disease. History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: AZD2066<br>* Capsule, once daily<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* Capsule, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Numerical Rating Scale (NRS) Pain Score From Baseline to Last 5 Days on Treatment | Mean pain intensity for 5-day baseline period (morning Day -5 to evening Day-1) and mean pain intensity for last 5 days on treatment (ie, last dose day and the 4 preceding calendar days) was calculated based on the NRS scale (0-10). 0=No pain, 10=Worst pain imaginable. | Change in mean pain intensity from 5-day baseline to the last 5 days on treatment, measure twice daily with NRS (12-hour recall) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients With ≥30% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 | NRS pain intensity score reduction=(change from baseline at Day 28/baseline)*100 Responder=pain intensity score reduction ≥30% (yes/no)? Responder rate=(no. of responders/total no. of patients)*100 | 28 days | 
| Patients With ≥50% Reduction From Baseline in NRS Pain Intensity Score (Responder Rate) at Day 28 | Pain intensity score reduction=(change from baseline Day 28/baseline)*100 Responder=pain intensity score reduction ≥50% (Yes/No)? Responder rate=(no. of responders/total no. of patients)*100 | 28 days | 
| Patients With Patient Global Impression of Change (PGIC) Score of at Least Much Improved (Responder Rate) at Day 28 | PGIC scale ranges from 1-7 where 1=Very much improved and 7=Very much worse Responder=Patient with a response of  much improved or very much improved Responder rate=(no. of responders/total no. of patients)*100 | 28 days | 
| Change in Short Form McGill Pain Questionnaire (SF-MPQ) Sensory Index From Baseline to Day 28 | Sensory index=sum of the intensity scale values of the words chosen for the descriptors 1-11 in the questionnaire. Range of scores for the sensory index=0-33 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated. | 28 days | 
| Change in SF-MPQ Affective Index From Baseline to Day 28 | Affective index=sum of the intensity scale values of the words chosen for the descriptors 12-15 in the questionnaire. Range of scores for the affective index=0-12 (higher score represents a worse condition). Change from baseline (measured prior to randomization) to Day 28 was calculated. | 28 days | 
| Change in Brief Pain Inventory-Short Form (BPI-SF) Pain Severity From Baseline to Day 28 | Change from baseline (measured prior to randomization) to Day 28 was calculated for the pain severity (mean of 4 intensity items). Each intensity item is recorded on a NRS 0-10, where 0=No Pain and 10=Pain as bad as you can imagine. | 28 days | 
| Change in BPI-SF Pain Interference From Baseline to Day 28 | Change from baseline (measured prior to randomization) to Day 28 was calculated for pain interference (mean of 7 interference items). Each interference item is recorded on a NRS 0-10, where 0=No interference and 10=Interferes completely. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Mechanical Hypersensitivity, Allodynia, Efficacy, analgesia, Neuropathic