Safety and Efficacy of AGN201781 in Neuropathic Pain

Phase 2

Terminated

• Conditions: Neuralgia
• Interventions: Drug: AGN201781; Drug: placebo

• Registration Number: NCT00533351
• Lead Sponsor: Allergan

Brief Summary

This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Study Start: 2008-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-12-15
• Results First Submitted QC: 2011-12-15
• Results First Posted: 2012-01-19
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
• Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia

Exclusion Criteria

• Women of child-bearing potential
• Any other uncontrolled diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AGN201781	AGN201781	AGN201781 50 mg capsules three-time daily for 2 weeks
Placebo	placebo	placebo 50 mg capsules three-times daily for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Pain Score at Week 2	Baseline, Week 2	Change from baseline in the daily-average-pain score at week 2. This was measured using a 11-point (0 to 10) scale where 0 represented no pain and 10 represented worst pain. Due to the low number of patients completing the treatment period of the study no analyses were performed

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Subject Global Impression of Change Score at Week 2	Baseline, Week 2	Change from baseline in Subject Global Impression of Change score at week 2. The Subject Global Impression of Change is a self-evaluation by the subject of their overall change in relief of neuropathic pain since the beginning of the study rated on a 7-point scale (1=very much improved to 7=very much worse). Due to low number of patients completing the treatment period of the study no analyses were performed.