Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

• Status: Completed
• Trial end date: 2012-08-31
• Target enrollment: 0
• Participant gender: All

Summary

The study is a randomized, double blind, cross-over study to evaluate the safety and efficacy of CNV1014802 in subjects with neuropathic pain from lumbosacral radiculopathy.

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

Details

• Lead Sponsor: Biogen; Convergence Pharmaceuticals

Criteria

Key Inclusion Criteria:

• Male or female aged between 18 and 65 years, with a diagnosis of neuropathic pain due to lumbosacral radiculopathy (LSR).

• Female subjects must be of non-child bearing potential or agree to use an approved form of contraception

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

• Capable of giving written informed consent.

• Approved concomitant medications must have been stable for at least 4 weeks prior to day 1.

• Average baseline daily pain score for neuropathic pain due to LSR on the 11-point numerical rating scale of 4 or greater.

Key Exclusion Criteria:

• Subjects who are unable to reliably delineate or assess their own pain by anatomical location/distribution.

• Subjects with lumbar canal stenosis in which the pain in the lower limbs occur solely on walking and not at rest.

• Subjects with causes for their neuropathic pain other than LSR.

• Subjects who have received nerve blocks and/or steroid injections for neuropathic pain within 4 weeks prior to day 1.

• Subjects who are indicated for surgical treatment of lumbosacral radiculopathy.

• 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.

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

• Subjects with a history of uncontrolled or poorly controlled hypertension, with systolic BP frequently exceeding 160mmHg and/or diastolic BP frequently exceeding 100mmHg, or subjects 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.

• Subjects 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 subject safety.

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

• Subjects who are unable to maintain their same medications for the treatment of neuropathic pain 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.

• Unable to stop and remain abstained from non-pharmacological treatments for their neuropathic pain during the study.

• History of hypersensitivity to CNV1014802.

• The subject 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 within 12 months prior to the first dosing day.

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

• Subject is mentally or legally incapacitated.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply