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CNV1014802 · 4 trials · 3 indications
Patients will be classified as a treatment failure if they meet one of the following criteria: * 50% increase in the frequency of paroxysms compared to the final 7 days of the open-label period * 50% increase in the severity of pain experienced in the paroxysms compared to the final 7 days of the open-label period * A Patient Global Improvement of Change rating of much worse/very much worse * The patient discontinues the study due to 'Lack of Efficacy'. v. The patient discontinues due to an adverse reaction or poor tolerability considered to be related to study medication
Change in average daily neuropathic pain score from baseline (average days 10-14) to week 3 based on the 11 point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=maximum pain imaginable). Subjects should specifically rate the pain intensity for the neuropathic pain associated with lumbosacral radiculopathy and not pain from other concomitant causes
| Arm | Type | Description |
|---|---|---|
| CNV1014802 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Other drug | EXPERIMENTAL | Other drug BID |
| Name | Type | Description |
|---|---|---|
| CNV1014802 | DRUG | CNV1014802 150mg tid for 28 days. Dose may be increased to 350mg bid following interim evaluation of efficacy. |
| Placebo | DRUG | Double-blind placebo comparator for 28 days. |
Inclusion Criteria: * Male or female aged between 18 and 70 years, with a diagnosis of trigeminal neuralgia; IHS criteria to be used. * Female patients must be of non-child bearing potential or agree to use an approved form of contraception * Male patients must agree to use an approved form of cont...
CNV1014802 is an investigational small molecule being studied for trigeminal neuralgia and lumbosacral radiculopathy. It has been evaluated in clinical trials for these neuropathic pain conditions, as well as in healthy volunteer studies.
CNV1014802 is being developed by Biogen Inc. (NASDAQ: BIIB). The company has sponsored clinical trials of the drug for trigeminal neuralgia and lumbosacral radiculopathy.
CNV1014802 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by regulatory authorities. Its development status is based on completed trials in healthy volunteers and patients with neuropathic pain conditions.
CNV1014802 has been studied in several completed trials. NCT01540630 was a Phase 2a withdrawal study in 67 patients with trigeminal neuralgia in the United Kingdom. NCT01561027 was a Phase 2 crossover study in 82 patients with lumbosacral radiculopathy across multiple European countries. NCT02359344 and NCT02551497 were Phase 1 studies in healthy volunteers.
CNV1014802 is also known as raxatrigine. This alternative name may appear in scientific literature and clinical trial registrations. Both names refer to the same investigational small molecule being developed by Biogen.