Chronic neuropathic pain in patients with diabetic peripheral neuropathy MedDRA version: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Sponsors
XTL Development Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Male or female, of any race, age 18 years or older. 2. Diagnosis of Type-I (insulin dependent) or Type-II (non-insulin dependent) diabetes mellitus. 3. Evidence of stable glucose levels over the three months prior to study entry, as documented by a written statement from the subject that their daily glucose levels have been stable and within normal limits, or, if outside normal limits that their diary shows stable values that are acceptable to the Principal Investigator at the site. Alternatively, a written statement from a physician or past laboratory values over the three month period prior to enrollment may be used to demonstrate stable glucose values. 4. Evidence of chronic bilateral pain due to diabetic neuropathy, which is defined as pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk deep tendon reflexes. 5. Presence of pain due to chronic diabetic neuropathy for at least 6 months prior to enrollment in Protocol B07-001. 6. Must have completed all visits of Protocol XTL B07-001 or 12 weeks of treatment at the target dose. 7. The primary pain location must be in the feet. 8. For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectable, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. 9. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 10. Subject must give written informed consent to participate. There must be evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent procedures of the study prior to performing any study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Subjects must meet all of the following criteria to be eligible for the study: 1. Male or female, of any race, age 18 years or older. 2. Diagnosis of Type-I (insulin dependent) or Type-II (non-insulin dependent) diabetes mellitus. 3. Evidence of stable glucose levels over the three months prior to study entry, as documented by a written statement from the subject that their daily glucose levels have been stable and within normal limits, or, if outside normal limits that their diary shows stable values that are acceptable to the Principal Investigator at the site. Alternatively, a written statement from a physician or past laboratory values over the three month period prior to enrollment may be used to demonstrate stable glucose values. 4. Evidence of chronic bilateral pain due to diabetic neuropathy, which is defined as pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk deep tendon reflexes. 5. Presence of pain due to chronic diabetic neuropathy for at least 6 months prior to enrollment in Protocol B07-001. 6. Must have completed all visits of Protocol XTL B07-001 or 12 weeks of treatment at the target dose. 7. The primary pain location must be in the feet. 8. For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectable, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. 9. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 10. Subject must give written informed consent to participate. There must be evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent procedures of the study prior to performing any study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The presence of any of the following conditions will exclude a subject: 1. Early discontinuation, for any reason, from Protocol XTL B07-001 2. Presence of other pain that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy such as peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis, fibromyalgia) 3. Symptoms of other painful conditions associated with diabetes such as thoracic radiculopathy or lumbar radiculopathy that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy 4. Presence of amputations other than toe amputations 5. History of lack of adequate therapeutic analgesic response to bicifadine, duloxetine or tricyclic antidepressants 6. History of any clinically significant psychiatric or other neurological disorder other than diabetic neuropathy, headache, or migraine headache 7. Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g., Alzheimer’s disease or schizophrenia or other psychosis), that in the investigator’s opinion may affect efficacy or safety assessments or may compromise subject safety during the trial 8. History (within the last 10 years) of any seizure disorder or epilepsy 9. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within the last 10 years 10. Current evidence of clinically important diseases of gastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems; urinary retention; or glaucoma 11. Female subjects who are pregnant and/or breastfeeding or have a positive serum pregnancy test at Visit 1 12. History of known alcohol or narcotic substance abuse within 2 years prior enrollment in XTL B07-001 13. History of any chronic illness other than diabetes that may interfere with or contraindicate participation in the study, as determined by the investigator 14. A body mass index (BMI) of greater than 40 15. Clinically relevant illness within the 30 days prior to the Baseline Visit that may interfere with the subject’s ability to complete the study 16. Any subject considering or scheduled to undergo any major surgical procedure during the study period ;Exclusion criteria: The presence of any of the following conditions will exclude a subject: 1. Early discontinuation, for any reason, from Protocol XTL B07-001 2. Presence of other pain that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy such as peripheral vascular disease (ischemic pain), neurological disorders unrelated to diabetic neuropathy (e.g., phantom limb pain from amputation), skin condition in the area of the neuropathy that could alter sensation (e.g., plantar ulcer), or other painful conditions (e.g., arthritis, fibromyalgia) 3. Symptoms of other painful conditions associated with diabetes such as thoracic radiculopathy or lumbar radiculopathy that could confound assessment or self-evaluation of the pain due to chronic diabetic neuropathy 4. Presence of amputations other than toe amputations 5. History of lack of adequate therapeutic analgesic response to bicifadine, duloxetine or tricyclic antidepressants 6. History of any clinically significant psychiatric or other neurological disorder other than diabetic neuropathy, headache, or migraine headache 7. Significant neurological or psychiatric symptoms resulting in disorientation, memory impairment, or inability to report accurately (e.g., Alzheimer’s disease or schizophrenia or other psychosis), that in the investigator’s opinion may affect efficacy or safety assessments or may compromise subject safety during the trial 8. History (within the last 10 years) of any seizure disorder or epilepsy 9. Any of the following within 1 year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm. Severe traumatic brain injury within the last 10 years 10. Current evidence of clinically important diseases of gastrointestinal, hematopoietic, renal, respiratory, or cardiovascular systems; urinary retention; or glaucoma 11. Female subjects who are pregnant and/or breastfeeding or have a positive serum pregnancy test at Visit 1 12. History of known alcohol or narcotic substance abuse within 2 years prior enrollment in XTL B07-001 13. History of any chronic illness other than diabetes that may interfere with or contraindicate participation in the study, as determined by the investigator 14. A body mass index (BMI) of greater than 40 15. Clinically relevant illness within the 30 days prior to the Baseline Visit that may interfere with the subject’s ability to complete the study 16. Any subject considering or scheduled to undergo any major surgical procedure during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of bicifadine SR in adult outpatients treated for chronic neuropathic pain associated with DPN for 52 weeks;Secondary Objective: ;Primary end point(s): Safety assessments using the following measures: Adverse events, concomitant therapy taken during the study, standard clinical laboratory tests and haemoglobin A1C, vital signs, physical examinations and 12-lead ECG with calculated QTc.;Main Objective: To assess the safety of bicifadine SR in adult outpatients treated for chronic neuropathic pain associated with DPN for 52 weeks;Secondary Objective: ;Primary end point(s): Safety assessments using the following measures: Adverse events, concomitant therapy taken during the study, standard clinical laboratory tests and haemoglobin A1C, vital signs, physical examinations and 12-lead ECG with calculated QTc. | — |
Countries
Germany
Contacts
Public Contact; ;
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Outcome results
None listed