A Phase IIa Withdrawal Study of CNV1014802 in Patients With Trigeminal Neuralgia

• Status: Completed
• Trial end date: 2014-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized withdrawal study comparing CNV1014802 with placebo in patients with trigeminal neuralgia who have successfully responded to CNV1014802 in an initial open-label phase.

Patients will participate in an initial open-label treatment period of 21 days of CNV1014802 150mg three times a day (tid). Responders will be randomized to 28 days of CNV1014802 150mg tid or placebo.

Following an interim analysis after 10 evaluable patients have completed the open-label phase, the dose regimen may be increased to 350mg twice a day (bid) for the remainder of the trial if the responder rate is less than 60%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen; Convergence Pharmaceuticals

Criteria

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 contraception

• Body weight > 50 kg for men and > 45 kg for women.

• BMI ≤ 34.9

• Capable of giving written informed consent. Informed consent must be obtained prior to the commencement of any study related procedures.

• QTcB either/or QTcF < 450 msec in two of three ECGs conducted at screening

• AST and ALT < 2xULN; alkaline phosphatase and bilirubin < 1.5xULN.

• Approved concomitant medications must have been stable for at least 3 weeks prior to day 0.

Exclusion Criteria:

• Patients who are known non-responders to sodium channel blockers at therapeutic doses.

• Patients with causes for their facial pain other than that specified in Inclusion Criterion

• A positive pre-study drug screen.

• A positive history of HIV.

• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.

• History of any liver disease within the last 6 months, with the exception of known Gilbert's disease.

• History of excessive regular alcohol consumption within 6 months of the study.

• Patients with a history or risk of seizures or a history of epilepsy, head injury or related neurological disorders

• Patients with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or patients who have BP greater than or equal to 160mmHg systolic and/or greater than or equal to 100mmHg diastolic at screening after repeated measurements

• History or presence of significant cardiovascular, gastro-intestinal, or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

• Patients with conditions known to affect cardiac conduction or a personal or familial history of Brugada syndrome

• Pregnant females or lactating females.

• History or presence of any clinically significant abnormality in vital signs/ECG/laboratory tests or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise patient safety.

• History of suicidal ideation and/or suicide attempts or clinical evidence of recent major depression.

• Patients who are unable to maintain approved medications for their trigeminal neuralgia at a stable dose during the study.

• Unable to refrain from excessive use of sedatives.

• Unable to comply with the prohibited concomitant medication restrictions as detailed in the protocol. This includes but is not limited to sodium channel blockers or drugs that adversely interact with a monoamine oxidase-B inhibitor: MAOI's, antidepressants, opioids and sympathomimetic agents.

• History of hypersensitivity to CNV1014802.

• The patient has participated in a clinical trial and has received an investigational product within 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to the start of this study.

• Exposure to more than four new chemical entities (medications for which no marketing authorization has been obtained) within 12 months prior to the first dosing day.

• Where participation in the study would result in total donation of blood or blood products in excess of 500mL within a 56 day period.

• Patient is mentally or legally incapacitated.

• Unwillingness or inability to follow the procedures outlined in the protocol.