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Clinical Studies
Results in Clinical Studies
PRIALT conducted three double-blind, placebo-controlled multicenter studies that included 457 patients (268 PRIALT, 189 placebo).3 Two of the studies used fast-titration schedules and one study used a slow-titration schedule.1
Patients who participated in the studies had mixed, neuropathic, and nociceptive pain types.3, 4
Safety Evaluation
- 1254 patients with severe chronic pain.1
- Mean duration of treatment was 193 days.1
Slow titration of PRIALT led to results in pain reduction.
In a controlled trial using the slow-titration schedule in patients with severe chronic pain (n=112 PRIALT-treated patients, n=108 placebo), patients were weaned from IT analgesics and started on systemic analgesics, including oral opioids, over a three-week period, followed by a one-week stabilization period. 93 percent of patients successfully completed the weaning process and entered the study. PRIALT or placebo was administered using an intrathecal pump for three weeks.1, 3
PRIALT dosing started at 2.4 mcg/day (0.1 mcg/hr) and increased by 2.4 mcg/day (0.1 mcg/hr) two to three times/week (minimum titration interval 24 hours) to a maximum dose of 19.2 mcg/day (0.8 mcg/hr) as needed for pain management. The final mean dose at the end of the trial at 21 days was 6.9 mcg/day (0.29 mcg/hr). The primary efficacy measure was a mean percent reduction in VASPI score from baseline to day 21.1
Slow Titration Study Design1
At week 3, PRIALT reduced pain from baseline significantly more than placebo (ITT population)
The mean daily dose at week 3 was 6.9 mcg/day.3
Use of weekly systemic opioids declined at the end of week 3 for both the PRIALT group and placebo group.3
*Data and results taken from intent-to-treat analysis
Patient Demographics in Slow Titration Study
Patients who participated in the slow-titration study had other prior treatments including oral opioids, non opioid medications, spinal cord stimulation, spinal surgery, neuroablation, physical therapy, and IT medications.3
Adult patients in this study had a long history of severe chronic pain.3
- 14-15 years approximate mean duration of pain
- 97% of patients refractory to treatment
- 80.7mm mean baseline VASPI (Visual Analog Scale of Pain Intensity) score
- 80% of subjects were receiving intrathecal drugs at the time of enrollment and required weaning
- 93% were successfully weaned from intrathecal medications to systemic analgesics
With slow titration, the incidence of discontinuations was approximately 5% in both the PRIALT-treated patients and in those who received a placebo.3
Most Common Adverse Events
The most frequently reported adverse reactions (≥25%) in clinical trials were dizziness, nausea, confusional state, and nystagmus.1
Adverse reactions during the slow-titration, placebo-controlled trial that occured in >/=5% of patients, and more commonly with PRIALT than placebo, are summarized below.1
| ADVERSE EVENT | PRIALT (n=112) % | PLACEBO (n=108) % |
|---|---|---|
| Dizziness | 46% | 13% |
| Nausea | 40% | 29% |
| Asthenia | 18% | 6% |
| Diarrhea | 18% | 15% |
| Somnolence | 17% | 10% |
| Vomiting | 16% | 14% |
| Confusional state | 15% | 5% |
| Abnormal gait | 14% | 2% |
| Ataxia | 14% | 1% |
| Headache | 13% | 11% |
| Blurred vision | 12% | 3% |
| Urinary retention | 9% | 0% |
| Amnesia | 8% | 0% |
| Anxiety | 8% | 3% |
| Nystagmus | 8% | 0% |
| Dysarthria | 7% | 0% |
| Memory impairment | 7% | 1% |
| Pruritus | 7% | 7% |
| Rigors | 7% | 5% |
| Tremor | 7% | 3% |
| Vertigo | 7% | 0% |
| Anorexia | 6% | 2% |
| Insomnia | 6% | 9% |
| Muscle spasms | 6% | 4% |
| Increased sweating | 5% | 6% |
| Dysgeusia | 5% | 5% |
| Pain in limb | 5% | 2% |
| Pyrexia | 5% | 3% |
| Sinusitis | 5% | 2% |
REFERENCES:
- PRIALT® (ziconotide) solution, intrathecal infusion [package insert]. Lake Forest, IL; TerSera Therapeutics.
- Wallace MS, Charapata SG, Fisher R, et al; Ziconotide Nonmalignant Pain Study 96‐002 Group. Intrathecal ziconotide in the treatment of chronic nonmalignant pain: a randomized, double‐blind, placebo‐controlled clinical trial. Neuromodulation. 2006;9(2):75‐86.
- Rauck RL, Wallace MS, Leong MS, et al; Ziconotide 301 Study Group. A randomized, double‐blind, placebo‐controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5):393‐406.
- Staats PS, Yearwood T, Charapata SG, et al. Intrathecal ziconotide in the treatment of refractory pain in patients with cancer or AIDS: a randomized controlled trial. JAMA. 2004;291(1):63‐70.