Diabetic Peripheral Neuropathic Pain
Conditions
Brief summary
Evaluation of the efficacy of LX9211 compared to placebo in reducing DPNP. Please see study website: https://diabeticpainstudy.com/
Interventions
LX9211 matching placebo tablets
DRUGLX9211 (blinded)
LX9211 (blinded) tablets
Sponsors
Lexicon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant has given written informed consent to participate in the study in accordance with local regulations 2. Adult male and female participants ≥18 years of age at the Screening Visit 3. Body mass index ≥18.0 to ≤40.0 kilogram per meter square (kg/m\^2) at Screening 4. Diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) with chronic DPNP, at Screening 5. Pain from DPNP present for at least 6 months prior to Screening 6. At the Screening Visit, glycosylated hemoglobin (A1C) must be ≤11%. 7. Stable regimen for the treatment of T1DM or T2DM for ≥3 months prior to Screening 8. Willing to adhere to the prohibitions and restrictions specified in the protocol.
Exclusion criteria
1. Presence of other painful conditions that may confound assessment or self-evaluation of DPNP 2. History of neurolytic or neurosurgical therapy for DPNP 3. Use of opioid medications for management of DPNP within the 2 months prior to the Screening Visit. 4. Use of prescription topical analgesics (eg, capsaicin) indicated for neuropathic pain within 3 months prior to Screening 5. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) less than 2 weeks prior to Screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 8 in Average Daily Pain Score (ADPS) | Baseline, Week 8 | ADPS is based on the 11-point numerical rating scale (NRS) \[0 (no pain) to 10 (worst imaginable pain)\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to Week 8 in Pain Interference on Sleep | Baseline, Week 8 | Pain interference on sleep is based on the 11-point NRS (0 \[does not interfere\] to 10 \[completely interferes\]). |
| Change from Baseline to Week 8 in Burning Pain | Baseline, Week 8 | Burning pain is based on the 11-point NRS (0 \[no burning\] to 10 \[worst burning imaginable\]). |
| Patient Global Impression of Change (PGIC) Score at Week 8 | Week 8 | The PGIC is a 7-point rating scale that assesses a participant's belief about the overall improvement experienced by the participant where 1=very much improved and 7=very much worse. |
| Change from Baseline to Week 8 in Total Neuropathic Pain Symptom Inventory (NPSI) Score | Baseline, Week 8 | NPSI total score is based on 5 subscales evaluating different symptoms of neuropathic pain, each evaluated on a scale of 0 (no pain) to 10 (worst pain). The total score ranges from 0 to 100. A higher score indicates a worse outcome. |
Countries
United States
Outcome results
None listed