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 range18 Years – 75 Years

SexALL

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.
✕. Has any clinically significant finding on a screening evaluation that in the judgment of the Investigator would preclude safe study completion.
✕. Liver function tests \>1.5 the upper limit of normal (ULN) for alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST)
✕. Serum creatinine \>1.5 ULN at screening
✕. Blood pressure \>160/110 mm Hg recorded on 3 readings at screening and/or resting pulse \>120 beats/min at screening
✕. Body temperature ≥101°F on day of planned injection
✕. Has a co-morbid medical condition of the spine or the upper extremities that may affect neurological and/or pain assessments as specified in the protocol, including spinal fusion, spondylolysis and spondylolisthesis.
✕. Has evidence of hip pathology based on clinical history, physical exam and/or radiographic imaging that could be the source of lumbar back pain.

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 range18 Years – 75 Years

SexALL

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.
✕. Has any clinically significant finding on a screening evaluation that in the judgment of the Investigator would preclude safe study completion.
✕. Liver function tests \>1.5 the upper limit of normal (ULN) for alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST)
✕. Serum creatinine \>1.5 ULN at screening
✕. Blood pressure \>160/110 mm Hg recorded on 3 readings at screening and/or resting pulse \>120 beats/min at screening
✕. Body temperature ≥101°F on day of planned injection
✕. Has a co-morbid medical condition of the spine or the upper extremities that may affect neurological and/or pain assessments as specified in the protocol, including spinal fusion, spondylolysis and spondylolisthesis.
✕. Has evidence of hip pathology based on clinical history, physical exam and/or radiographic imaging that could be the source of lumbar back pain.