Summary
Clonidine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. ClinicalTrials.gov lists 2 registered trials linking Clonidine Hydrochloride to Low Back Pain: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01415895). It plans or enrolled 78 participants. Registration activity spans 2011 to 2014. No published literature item is linked to Clonidine Hydrochloride and Low Back Pain in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
The RepurpOS disease-intelligence file for Low Back Pain ranks 331 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: ~90% of acute LBP episodes resolve within 6 weeks regardless of treatment; chronic LBP (>3 months) shows only 30-40% recovery at 1 year and high recurrence; opioid prescribing correlates inversely with recovery.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 24.0 (trials 4.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | agonist; agonist |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA2C |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01415895 | Naltrexone and Clonidine Combination (ATNC05) in the Treatment of Chronic Back Pain 2011 | completed | Phase 2 | 78 |
| NCT02239627 | Epidural Clonidine Versus Corticosteroid for Low Back Pain 2014 | terminated | Not applicable | 16 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: agonist; agonist.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Clonidine Hydrochloride approved for Low Back Pain?
Clonidine Hydrochloride has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Low Back Pain would be drug repurposing rather than first-in-human development. This does not mean it is approved for Low Back Pain. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Clonidine Hydrochloride in clinical trials for Low Back Pain?
ClinicalTrials.gov lists 2 registered trials linking Clonidine Hydrochloride to Low Back Pain: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT01415895). It plans or enrolled 78 participants. Registration activity spans 2011 to 2014.
What does the evidence show for Clonidine Hydrochloride in Low Back Pain?
Clonidine Hydrochloride has 1 completed registered trial for Low Back Pain but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.