NCT01561027

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2012

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 19, 2012

Last Update Submit

October 12, 2017

Conditions

Lumbosacral Radiculopathy

Outcome Measures

Primary Outcomes (1)

  • Change in Average Daily Neuropathic Pain Score from Baseline

    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

    Three weeks

Secondary Outcomes (6)

  • Numerical Pain Rating Scale

    3 weeks

  • Responder Rate

    3 weeks

  • Galer Neuropathic Pain Scale

    3 weeks

  • Oswestry Disability Index

    3 weeks

  • PGIC

    3 weeks

  • +1 more secondary outcomes

Study Arms (2)

CNV1014802

EXPERIMENTAL

CNV1014802 350mg on prescription (BID) for 21 days

Drug: CNV1014802

Placebo

PLACEBO COMPARATOR

Placebo 350mg BID for 21 days

Drug: Placebo

Interventions

CNV1014802DRUG

Administered as specified in treatment arm.

CNV1014802
PlaceboDRUG

Administered as specified in treatment arm

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Research Site

Brno, Czechia

Location

Research Site

Litoměřice, Czechia

Location

Research Site

Prachatice, Czechia

Location

Research Site

Glostrup Municipality, Denmark

Location

Research Site

Odense, Denmark

Location

Research Site

Lille, France

Location

Research Site

Nice, France

Location

Research Site

Paris, France

Location

Research Site

Saint-Etienne, France

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Stockholm, Sweden

Location

MeSH Terms

Interventions

vixotrigine

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 22, 2012

Study Start

April 30, 2011

Primary Completion

June 30, 2012

Study Completion

August 31, 2012

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

FR(4)CZ(3)SE(3)DK(2)