Clinical trial NCT01678924: A Safety and Efficacy Study of AGN-214868 in Patients With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuralgia, Postherpetic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of AGN-214868 in patients with postherpetic neuralgia (PHN).


Eligibility criteria: Inclusion Criteria:

* Postherpetic neuralgia with pain present for at least 9 months

Exclusion Criteria:

* Active herpes zoster skin rash
* Anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (TNS), or trigger point injection
* Anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study
* Use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study
* Use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study

Primary outcomes:
measure: Change From Baseline in Average Pain Intensity Score - Cohort 1
timeFrame: Baseline to Week 12
measure: Change From Baseline in Average Pain Intensity Score - Cohort 2
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 1
timeFrame: Baseline to Week 1
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 3
timeFrame: Baseline to Week 3
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 5
timeFrame: Baseline to Week 5
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 6
timeFrame: Baseline to Week 6
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 7
timeFrame: Baseline to Week 7
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 9
timeFrame: Baseline to Week 9
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 10
timeFrame: Baseline to Week 10
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 11
timeFrame: Baseline to Week 11
measure: Percentage of Average Pain Intensity Score Responders - Cohort 1 - Week 12
timeFrame: Baseline to Week 12
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 1
timeFrame: Baseline to Week 1
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 2
timeFrame: Baseline to Week 2
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 3
timeFrame: Baseline to Week 3
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 4
timeFrame: Baseline to Week 4
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 5
timeFrame: Baseline to Week 5
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 6
timeFrame: Baseline to Week 6
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 7
timeFrame: Baseline to Week 7
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 8
timeFrame: Baseline to Week 8
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 9
timeFrame: Baseline to Week 9
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 10
timeFrame: Baseline to Week 10
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 11
timeFrame: Baseline to Week 11
measure: Percentage of Average Pain Intensity Score Responders - Cohort 2 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 1 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Maximal Area of Spontaneous Pain - Cohort 2 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Area of Allodynia - Cohort 1 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Area of Allodynia - Cohort 2 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia Cohort 1 - Week 12
timeFrame: Baseline to Week 12
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 2
timeFrame: Baseline to Week 2
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 4
timeFrame: Baseline to Week 4
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 8
timeFrame: Baseline to Week 8
measure: Change From Baseline in Evoked Pain Score in the Area of Allodynia - Cohort 2 - Week 12
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Agave Clinical Research, LLC
state: Arizona
city: Tucson
country: United States
facility: Territory Neurology & Research Institute
state: Arizona
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Sacramento
country: United States
facility: Northern California Research Corp
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Boulder
country: United States
facility: Alpine Clinical Research Center
state: Colorado
city: Denver
country: United States
facility: The Mile High Research Center
state: Colorado
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Orlando
country: United States
facility: Compass Research, LLC
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Boise
country: United States
facility: Injury Care Research, LLC
state: Idaho
city: Bloomington
country: United States
facility: Millennium Pain Center
state: Illinois
city: Brockton
country: United States
facility: Beacon Clinical Research
state: Massachusetts
city: Springfield
country: United States
facility: Springfield Neurology Associates, LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurology Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Springfield
country: United States
facility: Clinvest Headache Care Center
state: Missouri
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: New York
country: United States
facility: The Medical Research Network, LLC
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates, P.C.
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Fargo
country: United States
facility: Plains Medical Clinic
state: North Dakota
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Altoona
country: United States
facility: Allegheny Pain Management
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina, LLC
state: South Carolina
city: Charleston
country: United States
facility: PharmaCorp Clinical Trials, Inc
state: South Carolina
city: Mount Pleasant
country: United States
facility: Clinical Research of Charleston
state: South Carolina
city: Webster
country: United States
facility: Center for Clinical Studies
state: Texas
city: Tacoma
country: United States
facility: MultiCare Neuroscience Center of Washington
state: Washington
city: Vienna
country: Austria
facility: SMZ-Ost Donauspital
city: Wien
country: Austria
facility: AKH Wien
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien
city: Kiel
country: Germany
facility: Pro scientia med im MARE Klinikum
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Berlin Research Centre
city: Bielefeld
country: Germany
facility: Regionales Schmerzzentrum DGS
city: Bochum
country: Germany
facility: Bochum Research Centre
city: Celle
country: Germany
facility: Das Schmerzzentrum Celle
city: Cologne
country: Germany
facility: Ambulant study centre
city: Dresden
country: Germany
facility: Leiter des Universitats Schmerz Centrums (USC)
city: Düsseldorf
country: Germany
facility: Neuro-Consil GmbH
city: Frankfurt
country: Germany
facility: Frankfurt Research Centre
city: Fulda
country: Germany
facility: Schmerz und Palliativzentrum Fulda
city: Goeppingen
country: Germany
facility: Schmerz und Palliativ- Zentrum Goeppingen
city: Hanau
country: Germany
facility: Klinikum Hanau GmbH
city: Heidenheim
country: Germany
facility: Neurologische Praxis Heidenheim
city: Hoppegarten
country: Germany
facility: Facharzt fur Neurologie
city: Kiel
country: Germany
facility: Schmerzklinik Kiel
city: Leipzig
country: Germany
facility: Medamed GmbH
city: Leipzig
country: Germany
facility: Leipzig Research Centre
city: Magdeburg
country: Germany
facility: Magdeburg Research Centre
city: Mainz
country: Germany
facility: Regionales Schmerz- und Palliativ Zentrum DGS Mainz
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
city: Villingen-Schwenningen
country: Germany
facility: Schmerztherapiezentrum Villingen-Schwenningen
city: Poznan
country: Poland
facility: Poznański Ośrodek Medyczny NOVAMED
state: Poznañ
city: Gdynia
country: Poland
facility: Medica Pro Familia Sp. Z.o.o SKA
city: Katowice
country: Poland
facility: Medica Pro Familia Sp. Z.o.o SKA
city: Krakow
country: Poland
facility: Malopolskie Centrum Medyczne S.C.
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Neurologiczny
city: Lublin
country: Poland
facility: Nzoz Neuromed
city: Poznan
country: Poland
facility: NZOZ Neuro-Kard
city: Swidnik
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej
city: Szczecin
country: Poland
facility: Osrodek Badan Klinicznych Euromedis Sp. z o.o.
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna PROSEN
city: Warszawa
country: Poland
facility: Medica Pro Familia Warszawa
city: Wroclaw
country: Poland
facility: Synexus SCM sp. z o.o.
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References: