Clinical trial NCT01561027: Crossover Study of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Official title: A Randomized, Double Blind, Cross-over Study to Evaluate the Safety and Efficacy of CNV1014802 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lumbosacral Radiculopathy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: The study consists of two treatment periods of 22 days with randomized CNV1014802 350mg or placebo administered twice daily. In addition, single blind placebo will be administered during a two week run-in, a two week wash-out period between the two treatment periods, and a one week run-out phase.

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Eligibility 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

Primary outcomes:
measure: Change in Average Daily Neuropathic Pain Score from Baseline
timeFrame: Three weeks
Secondary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: 3 weeks
measure: Responder Rate
timeFrame: 3 weeks
measure: Galer Neuropathic Pain Scale
timeFrame: 3 weeks
measure: Oswestry Disability Index
timeFrame: 3 weeks
measure: PGIC
timeFrame: 3 weeks
measure: CGIC
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Research Site
city: Litomerice
country: Czechia
facility: Research Site
city: Prachatice
country: Czechia
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Odense
country: Denmark
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Nice
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint-Etienne
country: France
facility: Research Site
city: Gothenburg
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: