EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
- Conditions
- Painful Diabetic Neuropathy
- Registration Number
- NCT05476276
- Lead Sponsor
- James P. Rathmell, MD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 122
3.1. Platform Protocol Inclusion Criteria (To be used in conjunction with ISA-specific<br>criteria. Note, some ISA criteria may be more stringent than Platform criteria; always<br>follow the more stringent criteria when determining eligibility.)<br><br>Participants must meet all of the following inclusion criteria:<br><br> 1. Able to provide informed consent. Legally Authorized Representatives (LARs) are not<br> allowed, but impartial witnesses may be utilized as needed for visually impaired<br> participants.<br><br> 2. 18 years of age and older<br><br> 3. Diagnosis of diabetes mellitus<br><br> 4. Meets the Toronto Criteria for probable clinical sensorimotor polyneuropathy, with<br> PDPN symptoms present for at least six months. This is defined as a combination of<br> symptoms and signs with any two or more of the following (must be present<br> bilaterally in the distal lower extremities): neuropathic symptoms, decreased distal<br> sensation, or unequivocally decreased (or absent) ankle reflexes. Specifically:<br><br> 1. The presence of any neuropathic symptoms on either the Douleur Neuropathique<br> en 4 Questions (DN4) or the EPPIC-Net Neuropathy Exam will suffice to<br> demonstrate neuropathic symptoms.<br><br> 2. Decreased distal sensation is satisfied by any of the following:<br><br> i. Yes is checked at least once under Question 3 of the DN4 which queries<br> hypoesthesia to touch and pinprick.<br><br> ii. At least one score of reduced or absent on the right AND at least one score<br> of reduced or absent on the left in any of the following items from the<br> EPPIC-Net Neuropathy Exam:<br><br> - Pin sensation in segments 1 or 2 (i.e. the toes and feet)<br><br> - Vibration at the great toe<br><br> - Joint position at the great toe<br><br> - Light touch/touch pressure at the great toe<br><br> - Temperature at the great toe<br><br> - Monofilament at the great toe c. Decreased or absent ankle reflexes is<br> satisfied by a score of reduced or absent on the right AND left in the<br> Ankle reflex item in the EPPIC-Net Neuropathy Exam.<br><br> 5. A score of at least 4 on the Douleur Neuropathique en 4 Questions (DN4).<br><br> 6. Pain reporting during a pre-defined 7-day screening period meets study criteria (to<br> be established using a centrally-administered screening algorithm) which may account<br> for mean pain intensity reported, variability in reported values, and adherence in<br> reporting.<br><br> 7. Patient reported daily 11-point NRS (for average and worst pain over the last 24<br> hours) is completed on at least 5 out of the 7 days in the screening and baseline<br> periods.<br><br> 8. Participants must be willing and able to comply with scheduled visits, the treatment<br> schedule, laboratory testing, and other requirements of the study (e.g., completion<br> of app-based daily reporting).<br><br> 9. Females may be included if they meet at least one of the following criteria (note<br> that individual ISAs may specify more stringent measures to prevent pregnancy):<br><br> a. Are not of childbearing potential, defined as one or more of the following: i.<br> Post-menopausal for at least 1 year ii. Surgically sterile (bilateral tubal<br> ligation, bilateral oophorectomy, or hysterectomy) iii. XY genotype iv. Turner<br> syndrome v. Uterine agenesis. b. Are completely abstinent from sexual activity<br> capable of resulting in pregnancy (as part of their preferred and usual lifestyle).<br> This will include females whose sole sexual partner is a male who has undergone<br> surgical sterilization or vasectomy.<br><br> c. Women of childbearing potential will agree to practice an effective form of two<br> types of birth control, which are defined as those, alone or in combination, that<br> result in a low failure rate (i.e., less than 1% per year) when used consistently<br> and correctly. This must be done before, throughout, and for 30 days after the last<br> dose of DB study drug. Acceptable methods are: i. Hormonal methods such as the<br> vaginal ring, or oral, implantable, injectable, or transdermal contraceptives for a<br> minimum of 1 full cycle (based on the participant's usual menstrual cycle period)<br> before study drug administration.<br><br> ii. Intrauterine device. iii. Barrier method of contraception: condoms with or<br> without a spermicidal agent, diaphragm or cervical cap with spermicide<br><br> 10. Specific requirements of male participants (regarding contraception) will be defined<br> in the ISAs based on the potential toxicity profile of the asset.<br><br>3.2. Platform Protocol Exclusion Criteria (To be used in conjunction with ISA-specific<br>criteria; note, some ISA criteria may be more stringent than Platform criteria; always<br>follow the more stringent criteria when determining eligibility)<br><br>Please note that some of the below criteria which depend on clinical judgment require<br>contacting the MM. Participants must not meet any of the following exclusion criteria,<br>organized by category:<br><br>3.2.1. Neuropathy Confound Exclusion Criteria<br><br> 1. Peripheral neuropathy that is known to have been caused by a condition other than<br> diabetes (e.g. HIV, cancer/chemotherapy-induced, other medication-induced,<br> alcohol-induced, hereditary, autoimmune neuropathies, uncontrolled or untreated<br> hypothyroidism). Note that participants will not be tested for HIV, this will be<br> established by patient report or review of the medical record.<br><br> 2. Other significant pain conditions involving the same area as the neuropathy (e.g.<br> physical deformity of the feet, plantar fasciitis, lumbosacral radiculopathy with<br> distal lower extremity pain, fibromyalgia involving the lower limbs, Morton's<br> neuroma), that in the opinion of the investigator would interfere with the<br> participant's ability to rate the neuropathy pain.<br><br> 3. Other pain conditions not involving the same area as the neuropathy which (in the<br> opinion of the investigator) interfere with the participant's ability to rate the<br> neuropathy pain.<br><br> 4. Any amputation of the lower limb which interferes with the participant's ability to<br> rate the neuropathy pain. If there is any amputation please contact the MM to<br> confirm eligibility prior to randomization to an ISA.<br><br> 5. The presence of any current foot ulcer.<br><br> 6. Significant peripheral vascular disease defined as symptoms consistent with<br> intermittent claudication.<br><br> 3.2.2. Medication/Treatment Exclusion Criteria<br><br> 7. Use of other investigational drugs within 3 months before screening and throughout<br> the study.<br><br> 8. Known or suspected hypersensitivity to all of the assets (active component and<br> excipients) currently being tested in the Platform Protocol.<br><br> 9. Undergone neurolytic or neurosurgical therapy or used an implanted neurostimulating<br> device for neuropathic pain in the distal lower limbs within 3 months of screening.<br><br> 10. Use of the high dose capsaicin patch (8%) in the 6 months before screening and<br> throughout the study (for the treatment of PDPN). Use of the capsaicin patch in a<br> manner that is not expected to interfere with the measurement of PDPN severity is<br> allowed.<br><br> 11. Participants who meet any of the following regarding concomitant treatments:<br><br> 1. Unwilling or unable to discontinue episodic or periodic treatments for pain in<br> the distal legs and/or feet (e.g., injections of lo
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Daily 0-10 pain NRS
- Secondary Outcome Measures
Name Time Method Pain, Enjoyment, and General activity scale (PEG);Pain Catastrophizing Scale - Short Form 6 (PCS-SF6);PROMIS Physical Functioning Short-Form 6b;Pain Health Questionnaire (PHQ-2);Generalized Anxiety Disorder - 2 item scale (GAD-2);Patient Global Impression of Change (PGIC);Tobacco, Alcohol, Prescription medication, and other Substance use Tool (TAPS-1);PROMIS Sleep Disturbance - 6A;Sleep Duration;Opioid Use Questionnaire (OUQ)