Diabetic Neuropathic Pain
Conditions
Keywords
Diabetic Asymmetric Polyneuropathy, Symmetric Diabetic Proximal Motor Neuropathy, Diabetic Mononeuropathy Simplex,, Diabetic Autonomic Neuropathy,, Diabetic Amyotrophy, Mononeuropathy, Diabetic Neuropathy, Asymmetric Diabetic Proximal Motor Neuropathy, Diabetic Polyneuropathy, Painful, Diabetic Mononeuropathy, Neuralgia
Brief summary
People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
Interventions
DRUGABT-639
ABT-639 Twice Daily for six weeks.
DRUGpregabalin
pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
DRUGPlacebo
Placebo twice daily for 6 weeks.
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * Subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
Exclusion criteria
* Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP. * A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions. * Subject has clinically significant abnormalities in clinical laboratory tests.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary | Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study) | Daily questions asked on a hand held diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Global Impression of Change | Week 2, Week 4 and Week 6 (End of Study) | Paper questionnaire |
| Brief Pain Inventory (BPI) (short form) including Severity and Interference | At each visit up to Week 6 (end of Study) | Paper questionnaire |
| Neuropathic Pain Symptom Inventory (NPSI) | Baseline, Week 2, Week 4 and Week 6 (end of Study) | Paper questionnaire |
Countries
Czechia, France, Germany, Mexico, United States
Outcome results
None listed