Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations).
In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series.
Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients.
This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia.
Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia.
The collected data will cover the first 2 years of treatment.

Start Date15 Sep 2024

Sponsor / Collaborator

Esteve Pharmaceuticals S.A.

NCT04321408 / RecruitingNot ApplicableIIT

OP2C : Prialt® Observatory in Clinical Practice

Ziconotide is a strong analgesic marketed since 2005 in Europe and reserved for the intrathecal route. Its efficacy has been proven in particular by 3 randomized clinical studies.
It is particularly effective on neuropathic pain and its main advantages are its power of action, the absence of bone marrow toxicity, and the absence of respiratory depression. In addition, there were no signs of withdrawal when stopping the drug, or of tachyphylaxis.
However, during these studies many adverse reactions were highlighted, especially neuropsychiatric which limited its use. This toxicity was mainly related to the administration of too high doses, especially at the start of treatment (too fast titration).
In recent years, the use of intrathecal ziconotide has become a pertinent option. Indeed, it is recommended as first-line among the intrathecal treatment options.
However, there is a lack of data on the current use of ziconotide in current practice.
The objective of the study will be to describe the practical methods of using intrathecal treatments containing ziconotide.

Start Date10 Jul 2020

Sponsor / Collaborator

Institut de Cancerologie de L Ouest

[+1]

NCT03942848 / Unknown statusPhase 3IIT

Assessment of Intrathecal Ziconotide Antalgic Efficacy for Severe Refractory Neuropathic Pain Due to Spinal Cord Lesions.

Spinal cord injury (SCI) has an average prevalence of 50 per 100.000 in general population (30.000 patients with SCI in France) with estimates of the overall prevalence for severe neuropathic pain ranges from 30 to 51% (up to 10.000 patients in France).
Patients with such spinal lesions may develop neuropathic pain called sublesional pain as perceived in an area below the level of injury. A second type of pain is at level of injury, i.e. perceived in a segmental pattern within the dermatome corresponding the spinal cord and nerve roots. These two types of pain are very harmful and are notoriously difficult to treat probably because of complex pathogenic mechanisms due to abnormal functioning of deafferented spinal and supraspinal nociceptive neurons.
Opioids, whatever be the route of administration, had demonstrated their inefficacy for these patients as well as several surgical techniques. So, chronic pain in relation with spinal lesion can be defined as real refractory pain.
Synaptic release of neurotransmitters is dependent on calcium intake trough voltage dependent channels. Type 2.1 or N-Type channels are specific for nociceptive system and can be blocked by a peptic neurotoxin: Ziconotide. Blocking these specific calcium channels neuromodulates nociception. Intrathecal use of Ziconotide, bringing the active molecule close to its receptors, has a proven clinical impact for a wide variety of pain (4). The intrathecal Ziconotide (ITZ) infusion using an implanted pump is validated for treatment of pain refractory to systemic analgesics (HAS, avis du 14-27 mai 2008). Meanwhile, no data are available in literature on positive effects of ITZ on specific spinal neuropathic pain.
A pilot study was performed by the coordinator team using ITZ on 12 patients with spinal pain: 8 patients had > 40% decrease of pain on numeric scale, 6 patients beneficiated from implanted pump allowing chronic ITZ treatment inducing 60% numeric scale decrease in average with 1 year follow-up.
Therefore intrathecal Ziconotide could be an excellent candidate for the treatment of spinal pain where the pain generators may be difficult to target by other available treatments.
This study is the first to assess ITZ (as IT antalgic monotherapy) versus placebo with a randomized controlled study with long follow-up. Trials have already been performed but not specially targeted spinal pain, and did not exceed three weeks follow-up.
Long term effects of Ziconotide on memory, cognition and mood have not been evaluated. In fact even though short term adverse effects on higher level functions have been described they have not been assessed in a placebo controlled situation.
Moreover, treating (successfully or not) patients with spinal pain could bring valuable insights both into the mechanisms of pain production in SCI patients and in the mechanisms of Ziconotide action: a positive result on pain below the injury level would imply action on the second or third order synapses of the nociceptive pathways. Similarly an effect at the level of pain, in absence of an effect below the level pain would argue discussion against such action. The impact of ITZ on the different clinical components of pain experienced by the patients, could also give some data on neuromodulation mechanism induced by the therapy.

Start Date20 Jun 2019

Sponsor / Collaborator

Hospices Civils de Lyon

100 Clinical Results associated with Ziconotide Acetate

100 Translational Medicine associated with Ziconotide Acetate

100 Patents (Medical) associated with Ziconotide Acetate

394

Literatures (Medical) associated with Ziconotide Acetate

01 Oct 2024·NEUROMODULATION

Intrathecal Ziconotide Infusion Therapy for Oncologic Refractory Neuropathic Pain: Case Report With High-Dose Intraventricular Ziconotide After 15 Years of Treatment

Article

Author: López-Millán, Jose M ; Coca-Gamito, Carmen

01 Oct 2024·Neuromodulation : journal of the International Neuromodulation Society

Physicochemical Stability Study of the Morphine-Bupivacaine-Ziconotide Association

Article

Author: Gouju, Julien ; Sorrieul, Jeremy ; Bienfait, Florent ; Dupoiron, Denis ; Robert, Julien ; Hamon, Sabrina Jubier ; Devys, Catherine ; Blanchet, Auriane

OBJECTIVE:

The aim of this study was to investigate the physicochemical stability of morphine-bupivacaine-ziconotide mixtures used in intrathecal analgesia in polypropylene syringes and intrathecal pumps.

MATERIALS AND METHODS:

The stability study method was conceived according to International Council for Harmonisation guidelines. For propylene syringes, six different mixtures of morphine-bupivacaine and ziconotide were assessed over seven days. Two storage temperatures were tested (5 °C ± 3 °C and 25 °C ± 2 °C). For implantable pumps, nine different mixtures were assessed over 60 days and stored at 37 °C. Assays were performed using ultrahigh-pressure liquid chromatography. Turbidity and pH also were measured throughout the study.

RESULTS:

Results confirmed excellent physicochemical stability for morphine and bupivacaine in the study for all conditions investigated (pumps at 37 °C, polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C). Concerning ziconotide, after seven days, our study showed that every 95% confidence interval calculated had lower bounds >90% for all mixtures stored in polypropylene syringes. In implantable pumps, a decrease of the concentration was observed in all the mixtures studied. Moreover, the appearance of a degradation product confirmed the ziconotide degradation.

CONCLUSION:

All results are in favor with a physicochemical stable preparation for six mixture profiles when stored in polypropylene syringes at 5 °C ± 3 °C and 25 °C ± 2 °C. For mixtures stored in implantable pumps, the efficacy should decrease over time owing to the degradation of ziconotide. A trade-off between high morphine concentration and increased refill interval will need to be found by clinicians.

01 Sep 2024·NEUROMODULATION

Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients

Article

Author: Hao, David ; Dumas, Cindy ; Narang, Sanjeet ; Rosenblum, Stuart ; Thorne, Rachel ; Di Capua, Christopher A. ; Di Capua, Christopher A

OBJECTIVES:

Currently, there are three monotherapy drugs approved by the United States Food and Drug Administration (FDA) for use in intrathecal drug delivery systems (IDDS): morphine, ziconotide, and baclofen. In practice, use includes alternate drugs, drug combinations, and drug concentrations. There is a paucity of real-world data examining prescription patterns for IDDS. Our analysis explores a one-year sample of prescription intrathecal (IT) medications from a large pharmaceutical data base to characterize medication usage in IDDS.

MATERIALS AND METHODS:

Data were provided by an accredited pharmacy as a deidentified data base of IT drug prescriptions. Statistical analyses included rates of monotherapy vs combination therapies, frequencies of various IT prescriptions, use of on- vs off-label medications, and opioid vs nonopioid formulations.

RESULTS:

Data were extracted from February 1, 2021 to February 14, 2022. No patients were excluded. The initial sample comprised 49,917 individual IT prescriptions for 32,784 patients. Monotherapies constituted 55.0% of all prescriptions (27,475/49,917). Of these, 23,257 prescriptions (84.6%) were opioid based, with the most common medications being morphine (46.5%), hydromorphone (39.4%), and fentanyl (13.5%). Although 29.3% of all prescriptions were for one of the FDA-approved medications, only 7.9% used FDA-approved concentrations; 9865 patients underwent ≥one prescription change in the study period-16.7% of whom were initially prescribed medications that met the approved, on-label indications for the pump before being switched to off-label concentrations or combinations to address clinical needs.

CONCLUSIONS:

Despite the prevalence of IDDS for managing chronic, intractable pain, minimal data exist on real-world prescription practices. Our study found that FDA-approved IT formulations accounted for the minority of prescriptions, indicating significant practice variation, with off-label prescriptions being common.

News (Medical) associated with Ziconotide Acetate

23 Jul 2024

·www.businesswire.com

Tersera Therapeutics LLC Announces That the 2024 Polyanalgesic Consensus Conference (PACC) Guidelines Issued Updated Guidance for Administering PRIALT

DEERFIELD, Ill.--( BUSINESS WIRE )--TerSera Therapeutics LLC announced today that the 2024 Polyanalgesic Consensus Conference (PACC) guidelines reinforce the role of non-opiate PRIALT in treating severe chronic pain. The 2024 PACC guidelines build upon prior iterations. This includes the 2016 PACC guidelines which recommend PRIALT as a first line option for neuropathic (chronic pain that occur when a health condition affects the nerves that send sensations to the brain) and nociceptive pain (pain caused by damage to body tissue). 1 The updated PACC Guidelines were published in the journal of Neuromodulation on May 16, 2024. 2 As noted in the guidelines, “proper individualized dosing is paramount for success with ziconotide.” The updated 2024 PACC guidelines discuss several crucial parameters for starting a patient successfully on PRIALT. Please refer to the full 2024 PACC Guidelines for additional information. 2 “The updated 2024 PACC guidelines provide clinicians with recommendations on how to manage PRIALT therapy for patients with severe, chronic pain,” said Gladstone C. McDowell II, MD. Dr. McDowell is the founder and former Medical Director of Integrated Pain Solutions in Columbus, Ohio and an author of the PACC guidelines. “In addition, it is beneficial to have an effective non-opioid analgesic option for this patient population. I appreciate having the ability to mitigate the potential risk of dependence and addiction for patients by using PRIALT.” Nancy Martin, MD, PharmD, Chief Medical Officer at TerSera, commented, “The PACC guidelines expert panel has continued to support PRIALT as an option for patients with severe, chronic pain who are refractory to other treatments." The International Neuromodulation Society (INS) commissioned a panel of distinguished clinical experts, and a series of Polyanalgesic Consensus Conferences produced the first guidelines after the inaugural meeting in 1999. 2 The authors of the PACC guidelines consist of an international, multidisciplinary team of experts in the intrathecal drug delivery . 1-2 PRIALT approved by the U.S. Food and Drug Administration (FDA) in 2004, is used to manage severe chronic pain in adults when other treatments do not work, stop working or cannot be tolerated. PRIALT is placed directly into the spinal fluid (termed “intrathecal” use) by a qualified physician who determines that the patient is appropriate for this procedure. PRIALT is not an opioid and is not a controlled, scheduled drug, meaning that the drug does not show the potential for dependence and subsequent abuse. 4 According to the Centers for Disease Control and Prevention (CDC), it is estimated that nearly 17 million Americans suffer from severe chronic pain of some kind. 3 Chronic pain conditions may be the result of more than one cause—damage to body tissues (nociceptive), damage to the nervous system (neuropathic), or a mix of the two. 1-2 Severe chronic pain patients are treated in a variety of ways, including use of oral opioids, transdermal opioids, physical therapy, injection therapy, spinal cord stimulation, spinal surgery, and more. When these methods do not adequately manage the individual’s pain, many doctors prescribe an intrathecal infusion treatment in which a pump is surgically implanted in the abdomen to deliver pain medication directly to the spinal cord to inhibit pain signals. In addition to PRIALT, only morphine is FDA-approved as an intrathecal (IT) infusion treatment for severe chronic pain. ABOUT TERSERA THERAPEUTICS TerSera Therapeutics is a biopharmaceutical company with a focus in oncology, acute care, and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying their ability to deliver meaningful outcomes for patients. For more information about TerSera Therapeutics, please visit tersera.com . ABOUT PRIALT 4 PRIALT intrathecal solution is an N-type calcium channel antagonist used to treat severe chronic pain in patient’s refractory to other treatments. PRIALT was first approved in 2004; PRIALT is available as a 1- or 5-mL vial of 100 mcg/mL solution or a 20 mL vial of 25 mcg/mL solution. INDICATION PRIALT is a prescription medicine used to treat severe chronic pain in adults who cannot take other treatments or when other treatments do not work, stop working, or cause bothersome side effects. PRIALT can only be delivered by or under the direction of a doctor who injects the medicine into your spinal fluid through a special device (a procedure called intrathecal infusion) and should only be used in patients who are appropriate for the procedure. IMPORTANT SAFETY INFORMATION PRIALT may cause serious side effects including psychiatric (mental) symptoms and problems thinking (confusion, memory problems, speech difficulties). The doctor should be called immediately if, while taking PRIALT, you are confused or disoriented, are less alert, see or hear things that are not real (hallucinations), have changes in mood or consciousness. Your doctor may stop your treatment with PRIALT, give you other medicines, or require you to be hospitalized if you experience any of these symptoms. You should not be given PRIALT if you: are allergic to PRIALT or any of its ingredients have a condition or are receiving a treatment that would cause an injection in your spinal fluid to be unsafe have or had a mental illness called psychosis (a loss of contact with reality), usually including delusions (false beliefs about what is taking place or who one is) or hallucinations (seeing or hearing things that are not real) PRIALT may cause or worsen depression, which increases the risk of suicide. People 65 years of age and older have a higher risk for confusion with PRIALT. Taking certain other medicines along with PRIALT may raise the risk of having problems with thinking or alertness. Tell your doctor about all the medicines you are taking. Meningitis (inflammation of the protective membranes covering the brain and spinal cord) or other infections can happen if the infusion device becomes contaminated. Tell your doctor right away if you have fever, headache, stiff neck, changes in mental status (feeling tired, confused, disoriented), nausea, vomiting, and/or seizures as these may be symptoms of developing meningitis. PRIALT may cause unconsciousness or reduced mental alertness. Avoid activities where you need to be alert, awake, and have full control of your body (activities like operating machinery or driving a car) during treatment with PRIALT. Tell the doctor if you experience new or worsening muscle pain, soreness, weakness or if your urine is dark in color as this could be a sign of rare but serious muscle side effects. You should also tell the doctor if you are pregnant, plan to become pregnant or if you are breastfeeding. The most common side effects of PRIALT include dizziness, nausea, confusion, and uncontrolled eye movements. These are not all the possible side effects of PRIALT. Talk to your doctor about any side affects you may be experiencing. To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch . You may also contact TerSera Therapeutics at 1-844-334- 4035 or medicalinformation@tersera.com . Please see Important Safety Information above and full Prescribing Information, including BOXED Warning. References 1. Deer T.R., Pope J.E., Hayek S., Lamer T.J., Veizi I.E., Erdek M., Wallace M.S., Grider J.S., Levy R.M., Prager J., Rosen S.M., Saulino M., Yaksh T.L., De Andres J.A., Abejon Gonzalez D.,Vesper J., Schu S.,Simpson B.,Mekhail N. 2017. The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks. Neuromodulation 2017; E-pub ahead of print. DOI:10.1111/ner.12579 2. Deer T.R., Hayek S.M., Grider J.S., Hagedorn J.M., McDowell G.C., Kim P., Dupoiron D., Goel V., Duarte R., Pilitsis J.G., Leong M.S., De Andrés J., Perruchoud C., Sukumaran H., Abd-Elsayed A., Saulino M., Patin D., Poree L.R., Strand N., Gritsenko K., Osborn J.A., Dones I., Bux A., Shah J.M., Lindsey B.L., Shaw E., Yaksh T.L., Levy R.M. 2024. The Polyanalgesic Consensus Conference (PACC)®: Intrathecal Drug Delivery Guidance on Safety and Therapy Optimization When Treating Chronic Non-cancer Pain. Neuromodulation 2024; -:1–33. 3. Rikard, S. M., Strahan, A. E., Schmit, K. M., & Guy Jr., G. P. (2023). Chronic Pain Among Adults — United States, 2019–2021. MMWR Morbidity and Mortality Weekly Report , 72(15), 433–438. 4. PRIALT ® (ziconotide). Prescribing information. TerSera Therapeutics LLC. PRIALT is a registered trademark of TerSera Therapeutics LLC ©2024TerSera Therapeutics LLC. All rights reserved. PRI-P-1170v2 (07/2024)

Drug Approval

09 Jan 2024

·www.biospace.com

Nura Pain Clinics Physician Treats First Patient in Minnesota with New Medtronic SynchroMed III Targeted Drug Delivery System for Pain

[09-January-2024] EDINA, Minn., Jan. 9, 2024 /PRNewswire/ -- Nura Pain Clinics, the Twin Cities' foremost multidisciplinary pain management clinic, announced today that the first patient in Minnesota has been implanted with the new Medtronic SynchroMed™ III implantable drug pump for the treatment of chronic pain. The implant procedure was performed by Nura's Dr. Erin Bettendorf, an experienced interventional pain management physician and Minneapolis native who graduated from Harvard Medical School. The patient, Scott Thompson, had an injury many years ago that caused severe chronic pain that limited his daily functioning and prevented him from being able to fully participate in activities he enjoyed. Despite trying a wide variety of treatments over many years, he continued to have debilitating pain. Scott eventually underwent a trial for targeted drug delivery at Nura, where he experienced the best pain relief he had in years and chose to proceed with a permanent intrathecal pain pump implant. Following the surgery, he was pleased with how comfortable he felt. Scott is excited to continue to recover and start getting back to his favorite hobbies that he has missed. "After 32 years of relentless, debilitating pain with no relief, I was given the gift of a brand-new start. Today, I was implanted with Medtronic's next-generation intrathecal pain pump which has already changed my life dramatically," said Thompson. "My life begins anew today, and I cannot wait to experience all that is ahead." Medtronic announced FDA approval of the new SynchroMed III implantable drug delivery system in October 2023 for treatment of chronic and cancer pain. The system alleviates symptoms by delivering medication directly to the fluid surrounding the spinal cord. SynchroMed III is an upgraded system compared to the SynchroMed II system, featuring improved electronics with firmware capable of being updated after implant, additional protections for patient data through enhanced cybersecurity, and a new "refill only" physician workflow for more efficient programming. The system also carries forward several mid-generation durable design enhancements from the SynchroMed II pump which have contributed to the long-term safety and reliability of the device.1 "At Nura, we focus on serving our patients with compassionate and individualized care and the most advanced technology, so I'm incredibly excited to be one of the first in the nation to provide this new pain management option to patients suffering from debilitating chronic pain, cancer pain or severe spasticity," said Dr. Bettendorf. "These patients have tried and exhausted many other options and Medtronic's new therapy offers pain relief and hope providing a better quality of life to those who so desperately need it." Opioid abuse and misuse remains a significant problem. Targeted drug delivery therapy is a safe, proven and effective way to manage chronic pain, cancer pain or severe spasticity with greater efficacy, fewer side effects and a high degree of clinician control as compared to oral medication.2,3,4,5,6,7,8 The system delivers medication directly to the fluid surrounding the spinal cord via a catheter connected to a small, battery-powered programmable pump. Patients with the SynchroMed III system will continue to have access to diagnostic imaging through industry-leading 1.5T and 3T full-body MRI conditionality.9 At Nura, patients can receive a full range of care from medication management, physical therapy and behavioral health coordinated with minimally invasive interventional procedures all within the same practice. This is a critical advantage for patients who otherwise may receive fragmented pain management by multiple providers at multiple locations. For more complex chronic pain problems, Nura offers a full range of implantable pain control options including spinal cord stimulation and targeted spinal drug delivery devices including the SynchroMed III system. Nura's multidisciplinary approach also aims to dial down the need for opioids to treat pain. For more information on Nura Pain Clinics and its focus on pain management, visit nuraclinics.com. About Nura Pain Clinics Nura (formally MAPS Medical Pain Clinics) was founded in 1995 by David Schultz, MD, a pioneer in interventional pain management. In his work as a practicing anesthesiologist in the 1990s, Dr. Schultz realized the need to treat chronic pain patients with a more comprehensive approach and went on to establish the region's first multidisciplinary pain management clinic, coordinating high tech interventional procedures with in-house physical therapy and psychology services. Nura is nationally recognized as a center of excellence for implantable pain control and one of the leading research centers in the U.S. for trials and implants of neuromodulation devices. Nura's mission is to improve the lives of people living with the most complex chronic pain through exceptional care. References 1 2022 Product Performance Report 2 Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13:1304-1313. 3 Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drugrelated toxicity, and survival. J Clin Oncol. 2002;20:4040-4049 4 Pope JE, Deer TR, Amirdelfan K, McRoberts WP, Azeem N. The Pharmacology of Spinal Opioids and Ziconotide for the Treatment of Non-Cancer Pain. Curr Neuropharmacol. 2017;15(2):206-216. 5 Meythaler JM, Guin-Renfroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109. 6 Gilmartin R, Bruce D, Storrs BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: Multicenter trial. J Child Neurol. 2000;15:71–77. 7 Meythaler JM, DeVivo MJ, Hadley M. Prospective study on the use of bolus intrathecal baclofen for spastic hypertonia due to acquired brain injury. Arch Phys Med Rehabil. 1996;77(5):461-466. 8 Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–1515. 9 Under specific conditions for 1.5 T and 3.0 T MRI scans. Refer to product labeling. MEDIA CONTACT Hyedi Nelson Bellmont Partners 651-757-7054 hyedi@bellmontpartners.com

100 Deals associated with Ziconotide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ziconotide Acetate	N02BG08	DB06283

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chronic Pain	US	TerSera Therapeutics LLCStartup	28 Dec 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Severe pain	Phase 3	US	Elan Corp. Plc	01 Feb 2004
Acquired Immunodeficiency Syndrome	Phase 2	US	Neurex Corp.	31 Aug 2001
Neoplasms	Phase 2	US	Neurex Corp.	31 Aug 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2006	Not Applicable	Tumor pain	67	Ziconotide	vhqcocrhda(ajtkyjnoii) = afakjwafjn vzlzwhghpj (gslinbdspe )	Positive	20 Jun 2006
				Placebo	vhqcocrhda(ajtkyjnoii) = jeybrlmyvh vzlzwhghpj (gslinbdspe )

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