Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01540630 | A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia | PHASE2 | COMPLETED | 67 | — | — | Mar 31, 2012 | Jun 30, 2014 | Jan 10, 2019 | 1 | United Kingdom |
| NCT02359344 | PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers | PHASE1 | COMPLETED | 32 | — | — | Feb 3, 2015 | Apr 20, 2015 | Oct 12, 2017 | 1 | United Kingdom |
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
| Arm | Type | Description |
|---|---|---|
| CNV1014802 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 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...