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Completed

NCT Number: NCT01129531

A Study of the Safety and Efficacy of AGN-214868 in Patients With Postherpetic Neuralgia

This study will evaluate the safety and efficacy of AGN-214868 in patients with postherpetic neuralgia (PHN) - nerve pain.

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Key information

Conditions

Neuralgia, Postherpetic Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent postherpetic neuralgia (PHN) with nerve pain present for at least 9 months after onset of herpes zoster skin rash

Exclusion criteria

  • Female patients with reproductive potential
  • Active herpes zoster skin rash
  • Current or anticipated treatment with acupuncture, TNS, or steroids
  • Current or anticipated use of topical analgesic agents with PHN
  • Treatment with botulinum toxin therapy of any serotype within the prior 12 weeks

Treatment and study plan

AGN-214868

Drug

AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.

Placebo to AGN-214868

Drug

Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.

Primary outcomes

  1. Change From Baseline in the Average Pain Intensity Score at Week 12

    Time frame: Baseline, Week 12

    Participants rated the severity of their daily pain in the previous 7 days using a 10 point scale where 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.

Secondary outcomes

  1. Change From Baseline in Area of Spontaneous Pain

    Time frame: Baseline, Week 12

    A tracing of the area of spontaneous pain was made and sent to an independent central reading center for measurement. The area of spontaneous pain was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.

  2. Change From Baseline in Area of Allodynia

    Time frame: Baseline, Week 12

    A tracing of the area of allodynia (pain to touch) was made and sent to an independent central reading center for measurement. The area of allodynia was measured in centimeters squared (cm^2) at Baseline and Week 12. A negative change from Baseline indicated improvement.

  3. Change From Baseline in Evoked Pain Score in the Area of Allodynia

    Time frame: Baseline, Week 12

    Participants were asked to rate the unpleasantness (pain to touch) after 3 brush strokes in the area of allodynia on a 100 point scale where 0=no pain to 100=worst pain imaginable. A negative change from Baseline indicated improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
May 24, 2010
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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