Study Stopped
This study was terminated early due to low enrollment.
Safety and Efficacy of AGN201781 in Neuropathic Pain
1 other identifier
interventional
9
2 countries
2
Brief Summary
This study will explore the safety and efficacy of AGN201781 in patients with postherpetic neuralgia or post-traumatic peripheral neuralgia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 21, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
January 19, 2012
CompletedFebruary 24, 2016
January 1, 2016
3 months
September 19, 2007
December 15, 2011
January 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Change From Baseline in Subject Global Impression of Change Score at Week 2
Baseline, Week 2
Study Arms (2)
AGN201781
EXPERIMENTALAGN201781 50 mg capsules three-time daily for 2 weeks
Placebo
PLACEBO COMPARATORplacebo 50 mg capsules three-times daily for 2 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of postherpetic neuralgia or post-traumatic peripheral neuralgia
- Moderate or severe pain associated with postherpetic neuralgia or post-traumatic peripheral neuralgia
You may not qualify if:
- Women of child-bearing potential
- Any other uncontrolled diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
St Leonards, New South Wales, Australia
Unknown Facility
Kiel, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated early due to low enrollment (only 9 of the required 40 subjects had been enrolled). Due to the low number of patients who completed the treatment period of the study, no analyses were performed.
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Allergan, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 21, 2007
Study Start
March 1, 2008
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 24, 2016
Results First Posted
January 19, 2012
Record last verified: 2016-01