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AZD5213+ pregabalin · 1 trial · 1 indication
Brief pain Index - diabetic painful neuropathy (BPI-DPN) - average daily pain, Item 5 (final 2 day diary + in clinic assessment at end of 3 week treatment period)
| Arm | Type | Description |
|---|---|---|
| placebo capsules | PLACEBO_COMPARATOR | Capsules to match pregabalin and AZD5213 |
| AZD5213 + pregabalin | EXPERIMENTAL | AZD5213 in combination with pregabalin |
| pregabalin | ACTIVE_COMPARATOR | pregabalin capsules |
| Name | Type | Description |
|---|---|---|
| AZD5213 + pregabalin | DRUG | Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules) |
| Placebo | DRUG | Double blind placebo capsules to match AZD5213 and pregabalin |
| pregabalin capsules | DRUG | Double blind pregabalin capsules to match AZD5213 and placebo |
Inclusion Criteria: 1\. Male or female, age 18 to 75 years, inclusive, at Screen. 2. Subjects must provide informed consent in accordance with local regulations before the conduct of any study-related procedures. The informed consent should reflect the protocol stipulations concerning the use of co...
AZD5213 is an investigational small molecule being studied for mild cognitive impairment, mild Alzheimer's disease, and painful diabetic neuropathy. It has also been evaluated in healthy volunteers for tolerability and for brain distribution of the radioligand [11C]AZ12807110. The drug is in clinical development and is not approved by the FDA.
AZD5213 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca has sponsored clinical trials of AZD5213 in the United States and Sweden.
AZD5213 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The completed trials include Phase 1 studies in healthy volunteers and Phase 2 studies in patients with mild cognitive impairment, mild Alzheimer's disease, and painful diabetic neuropathy.
AZD5213 has been studied in four completed clinical trials. NCT01121302 was a Phase 1 single ascending dose study in healthy subjects. NCT01194986 was a Phase 1 study of brain distribution and receptor occupancy. NCT01548287 was a Phase 2 study in mild cognitive impairment and mild Alzheimer's disease. NCT01928381 was a Phase 2 study in painful diabetic neuropathy.
No, AZD5213 and AZ12807110 are different compounds. AZ12807110 is a radioligand used in a clinical trial to measure histamine H3 receptor occupancy of AZD5213 in the brain. AZD5213 is the investigational drug being tested for its effects on cognitive impairment and diabetic neuropathy.