ISRCTN - ISRCTN17197655: Open Label Study of GLYX-13 in Subjects with Neuropathic Pain

Plain English Summary

Background and study aims
We are studying GLYX-13, a compound that has been administered to more than 500 subjects in other clinical trials. GLYX-13 interacts with a receptor in the brain that is thought to reduce pain intensity. In this study we will administer GLYX-13 by needle into a vein one time each week for 12 weeks, in subjects who have neuropathic pain, including pain due to diabetes mellitus and prolonged pain following shingles. The aim of the study is to assess the impact of GLYX-13 on pain.

Who can participate?
The study is open to participants aged 18-75, with neuropathic pain which has not responded to other drug therapy or who are not taking another drug.

What does the study involve?
Over a period of 12 weeks, participants will come to the study site once a week to receive a dose of GLYX-13 by needle into a vein. Throughout the 12 weeks, they will keep paper pain diaries which involve filling out simple questionnaires about pain intensity, and at the site visit each week, the investigator will ask questions about pain intensity during the past week. At the end of the 12 weeks, we will examine whether GLYX-13 affected pain intensity over the course of the study.

What are the possible benefits and risks of participating?
Subjects may experience less pain while taking GLYX-13. However, this will be the first study in which GLYX-13 is being evaluated for its ability to reduce pain, so we have no existing data about whether you may benefit.
The main risk of participation is related to GLYX-13 being an experimental drug. It has been administered in other clinical trials at dose levels up to 6 times the dose being administered in this trial, with no significant side effects. More than 500 subjects have received GLYX-13, about 200 of them received it weekly for 12 weeks.

Where is the study run from?
10 study sites located throughout the United States.
The study is run by Naurex, Inc, which is the company developing GLYX-13 as a drug.

When is study starting and how long is it expected to run for?
The study will begin in mid-December, 2014 and will run for approximately one year.

Who is funding the study?
Naurex, Inc.

Who is the main contact?
Ronald M Burch MD PhD, Chief Medical Officer, Naurex, Inc.
ronburch@naurex.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ronald Burch

ORCID ID

Contact details

433 West Morris Road
Morris
06763
United States of America
-
ronburch@naurex.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GLYX13-C-204

Study information

Scientific title

Open Label Pilot Efficacy and Safety Study of GLYX-13 in Subjects with Neuropathic Pain

Acronym

N/A

Study hypothesis

This study will examine whether GLYX-13 reduces pain in subjects with neuropathic pain.

Ethics approval

Quorum Review IRB, 30/10/2014, ref. QR29955

Study design

Open-label interventional trial to study GLYX-13 in subjects with neuropathic pain at up to 10 sites and 100 subjects.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neuropathic pain including post-herpetic neuralgia, diabetic neuropathy

Intervention

Subjects will receive a dose of GLYX-13, a drug that controls the level of activity of NMDA receptors in the brain. All subjects will receive one dose of GLYX-13 into a vein one time each week for 12 weeks.

Intervention type

Phase

Not Applicable

Drug names

GLYX-13

Primary outcome measure

Daily Assessment of Average Pain Intensity (DAPI) at the end of the study compared to the week prior to first dose of GLYX-13. The DAPI reports the worst pain during the day with pain being recorded upon waking up, at mid-day, and prior to going to bed. Pain will be rated using an 11-point scale with "0" being no pain to "10" being worst pain imaginable.

Secondary outcome measures

Daily worst pain:
1. Change in Brief Pain Inventory (BPI), a questionnaire
2. Neuropathic Pain Symptom Inventory (NPSI), a questionnaire
3. Mean Daily Sleep Interference Score (DSIS), a scale from "0" - no interference with sleep to "10" - interferes with sleep always
4. Patients Global Impression of Change (PGIC), a quiestionnaire
5. Change in consumption of concomitant pain medication, writing down the other pills taken to reduce pain

Overall trial start date

15/12/2014

Overall trial end date

30/12/2015

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male and female subjects
2. 18-75 years of age
3. Currently taking pain medications but pain is not adequately controlled, or currently not taking pain medication due to intolerance or lack of efficacy
4. Subjects who have experienced neuropathic pain not excluded in the exclusion criteria for 6 months or longer with pain score of 30/100 or greater by VAS at screening visit.
5. Female subjects of childbearing potential with a negative serum pregnancy test prior to entry into the study and who are practicing an adequate method of birth control (eg oral or parenteral contraceptives, intrauterine device, barrier, abstinence) and who do not plan to become pregnant during the course of the study. Female subjects may be included without a negative serum pregnancy test if they are surgically sterile or at least 2 years post-menopausal.
6. Male subjects who are abstinent during the course of the study or who use a condom during sexual intercourse.
7. Clinical laboratory values <2 times the upper limit of normal (ULN) or deemed not clinically significant per the investigator and Naurex medical monitor
8. Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assesments

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Currently hospitalized or residing in an in-patient facility during study participation
2. Substance abuse including greater than or equal to 5 units of alcohol per day where 1 unit = ½ pint of beer, 1 glass of wine 4 oz, or 1 oz. of spirits consumed most weeks or in the opinion of the investigator
3. Women who are planning to become pregnant during the course of the study
4. Participation in any clinical trial of an investigational product or device within 30 days of enrollment in this study.
5. Positive screen for drugs of abuse: cocaine, marijuana, PCP, ketamine, opioid or other agent that in the opinion of the investigator is being abused
6. Human immunodeficiency virus (HIV) infection (based on the based on the HIV-1 & HIV-2 antibody screen) or other ongoing infectious disease
7. Pain as a consequence of chemotherapeutic agent for any disease, alcohol- or HIV-induced neuropathic pain.
8. History of separate pain condition, eg, osteoarthritis that is more severe than the neuropathic pain syndrome
9. Lumbar-sacral radiculopathy or failed low back surgery
10. Pain with nerve injury expected to recover within 4 months
11. Complex regional pain syndrome type I
12. Concomitant peripheral neuropathy, paresthesia or dysthesia which cannot be differentiated from neuropathic pain due to other than neuropathic mechanism

Recruitment start date

15/12/2014

Recruitment end date

30/12/2015

Locations

Countries of recruitment

United States of America

Trial participating centre

433 West Morris Road
Morris
06763
United States of America

Sponsor information

Organisation

Naurex, Inc. (USA)

Sponsor details

1801 Maple Avenue
Suite 4300
Evanston
60201
United States of America
-
ronburch@naurex.com