| Study summary: |
|
Chronic neuropathic pain (NP) is caused by diverse etiologies resulting in damage to the
nervous system or dysfunction of the nervous system. Many common diseases, injuries, and
interventions cause neuropathic pain by producing lesions in the peripheral or central
nervous system. The current study is a randomized (study drug assigned by chance),
double-blind (neither the study doctor nor the patient knows the name of the assigned drug),
placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and tolerability of
JNJ-42160443 in patients with diabetic painful neuropathy, followed by a double blind
extension and an open-label (study doctor and patient knows the name of the study drug)
extension. This study will evaluate the safety and effectiveness of JNJ-42160443 in the
treatment of patients with moderate to severe, chronic, neuropathic pain that is not
controlled with or without standard pain therapy and who have a diagnosis of diabetic
painful neuropathy. The study has 5 phases: a screening phase of up to 35 days, a treatment
phase of 12 weeks, an optional extension phase of up to 40 weeks, an optional extension
phase of up to 52 weeks, and a follow-up phase of 26 weeks after the last dose of study
medication. Eligible patients will receive one dose of study drug (JNJ-42160443 or placebo)
given as an injection under the skin every 28 days during the 12-week treatment phase.
Patients who complete the 12-week treatment phase will be eligible to enter the optional
40-week extension phase or complete the study. During the 40-week extension phase, patients
will receive one dose of study drug (JNJ-42160443 or placebo) given as an injection under
the skin every 28 days. Patients who complete the 40-week treatment phase will be eligible
to enter the 52-week extension phase or complete the study. During the 52-week extension
phase, patients will receive one dose of study drug (JNJ-42160443) given as an injection
under the skin every 28 days. Assessments of effectiveness include assessment of daily
average pain intensity, worst pain, Brief Pain Inventory, Neuropathic Pain Symptom
Inventory, Patient Global Impression of Change, and other exploratory assessments (e.g.,
activity limitations). Safety assessments include physical examinations, neurologic
examinations and evaluations, nerve conduction studies, skin biopsies, monitoring of adverse
events, injection site evaluations, clinical laboratory evaluations, 12-lead
electrocardiogram, and vital signs. The study hypothesis is that JNJ-42160443 will show a
positive dose response relationship with respect to reducing average pain intensity in
patients with moderate to severe, chronic neuropathic pain. Doses in the 12-week treatment
and 40-week extension phases are Placebo, JNJ 42160443 1, 3, or 10 mg administered as a
single, subcutaneous (SC) injection every 28 days. The doses for the 52-week extension phase
will be up to 10 mg. |
| Criteria: |
|
Inclusion Criteria:
- Chronic neuropathic pain (pain persistent for > 6 months) that is moderate to severe
- Currently taking pain medication but are not adequately controlled by standard of
care (which may include antidepressants, antiepileptics, topical lidocaine, or
opioids), or are not currently taking pain medications because intolerable to, or not
willing to use, standard of care
Exclusion Criteria:
- Patients with severe diabetic neuropathy, defined by any 1 of the following: (1)
Severe autonomic dysfunction and severe blood pressure instability, (2) Loss or
decreased pinprick sensation above the knees or wrists (2) Women who are pregnant or
breast-feeding |