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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Convergence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01561027
First received: March 19, 2012
Last updated: August 2, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Lumbosacral Radiculopathy
Drug: CNV1014802
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Convergence Pharmaceuticals:

Primary Outcome Measures:
  • Change in average daily neuropathic pain score from baseline [ Time Frame: Three weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Numerical pain rating scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Change in average daily pain score from baseline (average days 10-14) to week 1 and week 2 of treatment and 1 week following the end of randomized treatment.

  • Responder rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who have >= 30% and >=50% reduction in average daily pain score relative to baseline during weeks 1, 2 and 3 of treatment and 1 week following the end of randomized treatment.

  • Galer neuropathic pain scale [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Change in Galer Neuropathic Pain Scale from baseline to week 3 of treatment.

  • Oswestry Disability Index [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Change in average disability score from baseline to week 1, week 2 and week 3 of treatment based on Oswestry Disability Index

  • PGIC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Patient Global Impression of Change (PGIC) on week 3 of treatment.

  • CGIC [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Proportion of patients who have "improved", "much improved" or "very much improved" relative to baseline on the Clinical Global Impression of Change (CGIC) on week 3 of treatment.


Enrollment: 82
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNV1014802 Drug: CNV1014802
CNV1014802 350mg bid for 21 days Matching placebo
Placebo Comparator: Placebo Drug: CNV1014802
CNV1014802 350mg bid for 21 days Matching placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01561027

Sponsors and Collaborators
Convergence Pharmaceuticals
Investigators
Principal Investigator: Bjorn Bragee, MD Bragee Medect AB, Stockholm, Sweden
  More Information

No publications provided

Responsible Party: Convergence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01561027     History of Changes
Other Study ID Numbers: CNV1014802/201
Study First Received: March 19, 2012
Last Updated: August 2, 2012
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neuralgia
Radiculopathy
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014