Safety and Efficacy of AGN201781 in Neuropathic Pain

Neuralgia Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00533351
• Other study ID #: 201781-504
• Status: Terminated
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: January 27, 2016
• Start date: March 2008
• Est. completion date: June 2008

Study information

• Verified date: January 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustralia: Therapeutic Goods Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia

Intervention

Drug:
• AGN201781
AGN201781 50 mg capsules three-times daily for 2 weeks
• placebo
placebo 50 mg capsules three-times daily for 2 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Daily Pain Score at 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	Baseline, Week 2	No
Secondary	Change From Baseline in Subject Global Impression of Change Score at 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.	Baseline, Week 2	No