CompletedPhase 1

AMG0103 in Subjects With Chronic Discogenic Lumbar Back Pain

United States25 participantsStarted 2018-02-26

Plain-language summary

This clinical trial evaluate the safety, tolerability and exploratory efficacy of targeted single injection of AMG0103 in subject with chronic discogenic lumbar back pain

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female, between 18 and 75 years of age, inclusive, and skeletally mature, in the opinion of the investigator.
. Has provided written informed consent before undergoing any study-specific procedures.
. Has chronic low back pain for at least 6 months, where back pain is greater than leg pain.
. Has separate low back pain and leg pain VAS scores within the following parameters:
. Average low back pain VAS score of at least 40 mm and less than 90 mm on a 100 mm visual analog scale.
. Average leg pain VAS score that is less than or equal to 50% of the average low back pain VAS score above, where leg pain VAS scores are measured on a 100 mm visual analog scale.
. Has had inadequate response to conservative medical care over a period of at least 3 months.
. Diagnosis of painful degenerative disc disease at one lumbar level from L1 to S1 confirmed by subject history and radiographic studies (eg, MRI, x-rays). Radiographic studies must demonstrate the following:

Exclusion criteria

. Has any prior or current medical condition (eg, an active systemic infection), including known bleeding disorders that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety: treatment-emergent adverse events (AEs)

Timeframe: 6 months

Safety: data from 12-lead electrocardiograms

Timeframe: 6 months

Safety: data from clinical laboratory evaluations (hematology, serum chemistry, coagulation, inflammation and immunology)

Timeframe: 6 months

Trial details

NCT IDNCT03263611

SponsorAnGes, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-15

View on ClinicalTrials.gov More Degenerative Disc Disease trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male or female, between 18 and 75 years of age, inclusive, and skeletally mature, in the opinion of the investigator.
. Has provided written informed consent before undergoing any study-specific procedures.
. Has chronic low back pain for at least 6 months, where back pain is greater than leg pain.
. Has separate low back pain and leg pain VAS scores within the following parameters:
. Average low back pain VAS score of at least 40 mm and less than 90 mm on a 100 mm visual analog scale.
. Average leg pain VAS score that is less than or equal to 50% of the average low back pain VAS score above, where leg pain VAS scores are measured on a 100 mm visual analog scale.
. Has had inadequate response to conservative medical care over a period of at least 3 months.
. Diagnosis of painful degenerative disc disease at one lumbar level from L1 to S1 confirmed by subject history and radiographic studies (eg, MRI, x-rays). Radiographic studies must demonstrate the following:

Exclusion criteria

. Has any prior or current medical condition (eg, an active systemic infection), including known bleeding disorders that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements.