A Pilot, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with a 4-Week Treatment Period Followed by a 4-week Observation Period and an Optional 4 Month Observation Period of the Safety and Duration of Efficacy of AGN 201781 in Subjects with Neuropathic Pai

• Conditions: Postherpetic neuralgia or post-traumatic peripheral neuralgia

• Registration Number: EUCTR2007-003787-21-DE
• Lead Sponsor: Allergan Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Subject has provided written informed and Data Protection consent prior to initiating any study specific screening procedures.
2.Males or females (non-child bearing potential, defined as post-menopausal for at least 12 months, hysterectomy or bilateral oophorectomy), 18 – 80 years of age.
3.Clinical diagnosis of one or the other of the following neuropathic pain conditions:
•Postherpetic neuralgia (PHN) present for a minimum of 6 months after onset of rash.
•Post-traumatic peripheral neuralgia [Mechanical injury (including surgical injury) to peripheral nerves/root e.g. stabbing or burning pain that persists to a varying degree within the affected or adjacent area of trauma or corresponding dermatome for 6 months or more after the precipitating insult].
4.Subjects with history of cancer (except basal cell carcinoma) should be in complete remission (defined by NCI as follows: all signs and symptoms of cancer have disappeared, although cancer still may be in the body) for at least 12 months prior to baseline and throughout the baseline period.
5.Subject has pain defined as:
•A mean daily-average-pain score of at least 4 and no greater than 9 on the 11 point Likert Scale during the last 7 days of the baseline period.
•Subject must complete their pain diaries for at least 6 of the last 7 days of the baseline period.
•PHN or post-traumatic peripheral neuralgia is the subject’s predominant pain condition and he/she is able to distinguish between the neuropathic pain and other concurrent painful conditions.
6.The subject must be able to understand and cooperate with study requirements, including e-diary administration and willing and able to complete the entire course of the study.
7.Subject is eligible for enrollment as determined by the investigator from medical history, physical examination findings, 12-lead electrocardiograph (ECG) findings, and clinical laboratory test results. Laboratory results outside of the reference range must be documented as acceptable by the investigator. In addition, the liver function tests, thyroid function tests and creatinine clearance (calculated) must be within the specific ranges below:
•ALT and AST < 1.5 times the upper reference range
•Creatinine Clearance (calculated) > 70 mL/min
•FT3 and FT4 > lower reference range or < 1.1 times the upper reference range
•TSH within normal reference range

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Uncontrolled concurrent disease.
2.Pain resulting from injury to the spinal cord or central neuropathic pain (e.g. post-stroke) as indicated by medical history and clinical evaluation (e.g. pain evident at more than one dermatome below the level of the neurologic lesion).
3.Post-traumatic peripheral neuralgia with evidence of an ongoing insult to the nerve (e.g. nerve compression as a result of a herniated disc).
4.Any significant disease or other significant abnormal findings at the screening and or baseline evaluation, as determined by the investigator.
5.History of treatment for, or evidence of, alcohol or drug abuse within the past year or regular alcohol consumption exceeding an average of 3 units of alcohol per day (Attachment 13.3).
6.Beck Depression Inventory (BDI) score >20 at baseline.
7.Subject with a score of = 2 on question 9 (suicide) of Beck Depression Inventory at baseline visit, or is deemed by the investigator to be at risk of significant self harm.
8.Use of topical capsaicin within 4 weeks prior to the start of the baseline period and throughout the baseline period.
9.Concurrent treatment or history of treatment within 2 weeks prior to the start of the baseline period and throughout the baseline period with the following:
•Tricyclic antidepressants (TCAs) (e.g. amitriptyline)
•Serotonin norepinephrine reuptake inhibitors (SNRIs) (e.g. duloxetine)
•Alpha-adrenergics - agonists or antagonists (e.g. clonidine)
•Monoamine oxidase (MAO) inhibitors (e.g. tranylcypromine)
•Opioids including tramadol (e.g. oxycodone)
•Topical analgesics (e.g. lidocaine)
•Antiarrhythmics or NMDA antagonists (e.g. mexiletine)
•Benzodiazepines (e.g. diazepam)
•Muscle relaxants (e.g. baclofen)
In addition, concurrent treatment or history of treatment within 24-hours prior to the start of the baseline period and throughout the baseline period with acetaminophen (Tylenol).

10.Concurrent treatment or history of treatment for cancer including radiation therapy, chemotherapy, etc. (except for non-chemotherapy adjuvant therapy, e.g. exemestane), within the last 12 months prior to the start of the baseline period and throughout the baseline period.

11.Subject being treated with an anti-convulsant (e.g. gabapentin) and/or NSAIDS (e.g. acelofenac), and is NOT on a stable dose for at least 3 weeks prior to the start of the baseline period and throughout the baseline period.

12.Significant changes in the doses of current chronic medications except for the washout medication(s) within 4 weeks of baseline and throughout the baseline period.

13.Participation in an investigational drug or device study or participation in such a study within 30 days of screening and/or between screening and randomization.

14.Exposure to botulinum toxin (of any serotype) in the area affected by neuropathy within the previous 6 months prior to the start of the baseline period and throughout the baseline period.

15.History of gastrointestinal (GI) conditions or gastric motility disorders that could affect drug absorption.
16.Subjects with a history of gastrointestinal bleeding or gastric ulcers.
17.Any allergic reaction to any compound or chemical class related to AGN 201781 (alpha-2 agonists) or its excipients.
18.Any allergic reaction to Ibuprofen
19.Subjects on anticoagulant therapy
20. Subject has a positive test for the presence of Hepatitis C virus antibodies (HCAb), Hepatitis B surface antigen or human immunodeficiency virus (HIV) an

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and explore the duration of analgesia with AGN 201781 in the treatment of pain associated with postherpetic neuralgia and post-traumatic peripheral neuralgia.;Secondary Objective: ;Primary end point(s): Daily-average pain score [11-point Likert scale, question 1 on the electronic diary (eDiary)]