Preserved supervised synthesis

Ziconotide synthesis · version 1

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Supervised synthesis

What do selected human studies report about Ziconotide?

Manually reviewed September 15, 2026 · version 1

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Three selected placebo-controlled trials examined intrathecal ziconotide for severe refractory pain. Intrathecal delivery and the studied populations are essential context; these are not general-use pain studies.123

Bottom line from this bounded source set

The trials reported greater short-term pain-score improvements than placebo, with neurological and other adverse effects. Differences in trial duration and exposure schedules limit comparisons among studies.123

Reviewed study record

Severe chronic pain: three-week trial

Design

Randomized placebo-controlled study with gradual exposure adjustment over three weeks.1

Population

112 people were assigned ziconotide and 108 placebo.1

Outcomes reported

Mean pain-score improvement was 14.7% versus 7.2%. Reported adverse effects included dizziness, confusion, impaired coordination, abnormal gait and memory impairment.1

Limitations

The short trial cannot establish durable benefit or uncommon harms. Similar discontinuation rates do not remove the neurological safety concerns.1

Reviewed study record

Pain associated with cancer or AIDS

Design

Randomized, double-blind, placebo-controlled trial with a brief initial comparison followed by maintenance or crossover.2

Population

111 adults with severe refractory cancer- or AIDS-associated pain were enrolled.2

Outcomes reported

Mean pain-intensity improvement during the initial comparison was 53.1% versus 18.1%.2

Limitations

Brief comparison, crossover and a highly selected population limit long-term interpretation. The abstract does not give a sufficiently detailed adverse-event account.2

Reviewed study record

Severe nonmalignant pain

Design

Randomized, double-blind, placebo-controlled inpatient trial over six days.3

Population

169 participants received ziconotide and 86 placebo.3

Outcomes reported

Mean pain-score reduction was 31.2% versus 6.0%. Adverse events prompted a protocol exposure reduction and included gait and visual disturbances, dizziness, nausea and urinary retention.3

Limitations

Rapid exposure adjustment contributed to substantial adverse effects. The short historical protocol is study context, not a treatment recommendation.3

Reviewed source set

  1. PubMed · 16716870A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. ↗PubMed PMID 16716870 · EFetch XML reviewed 2026-09-15 · payload SHA-256 2337a3d1806860de36704066fc61a1dd7d31ac372bfb9a35d3d47ab70c303e38
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1016/j.jpainsymman.2005.10.003. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  2. PubMed · 14709577Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. ↗PubMed PMID 14709577 · EFetch XML reviewed 2026-09-15 · payload SHA-256 9a56770d7d521c5604f59d2f1398a5ee502e72771c391574264c3f174d3e2315
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1001/jama.291.1.63. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗
  3. PubMed · 22151630Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a randomized, double-blind, placebo-controlled clinical trial. ↗PubMed PMID 22151630 · EFetch XML reviewed 2026-09-15 · payload SHA-256 4e1ebfeb4d740d3b9e68fef57e196f0868485cb4b106e06db406b5689992d058
    No registered Crossref update in the reviewed snapshotChecked September 15, 2026 for DOI 10.1111/j.1525-1403.2006.00055.x. This bounded result is not proof that the publication has never been corrected or retracted. Open the pinned Crossref work endpoint ↗