Phase 2
Completed N=31
A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Early Lumbar Disc Degeneration
Source: ClinicalTrials.gov NCT01182337 ↗
Enrolled (actual)
31
Serious AEs
22.6%
Results posted
Jan 2016
Primary outcomePrimary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants
Summary
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neurological Assessment for Motor Function and Reflexes/Sensory |
0; 0 | — |
| PRIMARY Treatment Emergent Adverse Events- Relationship to Study Drug |
0; 1 | — |
| SECONDARY Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline. |
-13.5; -10.4 | — |
| SECONDARY Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline. |
-2.49; -1.42 | — |
| SECONDARY Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline |
2.52; 3.24 | — |
| SECONDARY Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline. |
4.03; 4.34 | — |
Eligibility Criteria
Inclusion Criteria
- Persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration, with an expiry of 12 months from the date performed.
- Oswestry Disability Index (ODI) for low back pain of 30 or greater
- Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
- Male or Female 18 years of age or older
Exclusion Criteria
- Persons unable to have a discogram, CT, or MRI
- Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
- Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
- Extravasation of contrast agent during the discogram into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
- Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
Data sourced from ClinicalTrials.gov (NCT01182337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.