A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of a Single Treatment of AGN-214868 in Patients With Postherpetic Neuralgia
University of California, Irvine campus in Irvine, CA.
This is a research study sponsored by Allergan for subjects with
Postherpetic Neuralgia (PHN). PHN is a type of chronic pain after shingles caused by
activation of a virus from a previous infection (chicken pox). This type of pain is called
neuropathic pain and may produce a number of unpleasant symptoms such as burning/tingling or severe pain even to light touch. This study involves the use of an
investigational drug called AGN-214868.
The investigational study drug, AGN-214868 is being developed by the sponsor,
Allergan, as an injectable intradermal (ie, under the skin) treatment for chronic pain.
AGN-214868 is thought to target nerve cells involved in feeling pain and could
potentially reduce chronic pain. The purpose of the study is to compare the safety and
effectiveness of AGN-214868 to placebo (a medically inactive substance) in subjects with
post herpetic neuralgia (PHN).
The purpose of the study is to compare the safety and effectiveness of AGN-214868 to
placebo (a medically inactive substance) in patients with post herpetic neuralgia (PHN).
Specifically, the aims of this study are to determine:
- How safe the study drug is
- How well the drug reduces chronic pain
- What the body does to the study drug
- Adults between the ages of 18 and 80 suffering with persistent PHN with
moderate pain for at least nine months after the onset of a shingles skin rash located
anywhere below their hairline.
- Subjects may not be taking any chronic pain medication for at least 28 days before
receiving study drug and remain off chronic pain medication until after the week
12 visit, other than acetaminophen and aspirin.
- Subjects must not have active shingles (herpes zoster) skin rash.
- Subjects must not have received BOTOX® or other botulinum toxin injection
within 24 weeks before Visit 2.
- Male and female subjects must agree to use a highly effective form of birth
control during participation in this study
- Female subjects must not be pregnant, breastfeeding or planning on becoming
pregnant during their participation in the study.
Participation in this study will be up to 53 weeks (just over a
year). During this time, up to 10 clinic visits will be required. In some cases, the
screening and baseline visits may be combined into one visit. The visits will vary in
length, but are expected to last on average 1-4 hours each. The visit in which subjects
receive treatment will be a minimum of 4 hours. This study will take about 23 hours of your time.
While researchers hope AGN-214868 will be more
effective and have fewer side effects than the standard (usual) treatment, there is no proof of this yet.
Subjects who are in the group that receives AGN-214868 and it proves to treat their
condition more effectively and/or/with fewer side effects than placebo, may benefit from
participating in the study, but this cannot be guaranteed.
Future patients with Post Herpetic Neuralgia may benefit from the knowledge and
development of treatments developed from this study.
Total compensation for participation in the entire study is
$460.00. Subjects will receive a check for the study visits completed according to the following schedule.
- $90.00 for Visit 1 and Visit 3,
- $45.00 each for Visit 5, Visit 6, Visit 7 and Visit 8
- $25.00 each for Visit 2, Visit 4, Visit 9, Visit 10.
- In addition, subject will receive $25.00 for each unscheduled visit (if applicable).
There will be no costs associated with participation in this study, such as the study
medication, office visits, laboratory tests or examinations related to the study
Shari Niswonger, RN