Omaha drug trial shows promise for pain condition

OMAHA, Neb. —
An Omaha researcher is conducting a drug trial for a drug that’s already being prescribed for a chronic pain condition for patients in Europe.
Dr. Robert Recker with Creighton University is looking for patients with Complex Regional Pain Syndrome to test the drug which comes from a class of drugs normally used to treat osteoporosis. Recker said CRPS is rather "An area of the body starts to have really severe pain for no reason. You look at it on x-ray, no matter how you look at it, you don’t find anything wrong,” said Recker who’s testing an intravenous treatment called Neridronic Acid.
“I can't deny the fact that the study in Italy cause it to be approved for it. Apparently it removes the pain quite strikingly,” said Recker.
Ron Dulas, of Lincoln has lived with CRPS for more than six years, with debilitating pain in his leg, travelling to his hands. The pain started after back surgery, for no apparent reason.
“It was horrendous. It's like someone took a hammer and just smacked your foot,” said Dulas, who’s on a number of prescription pain relievers and has been for years. He eventually had to quit his job restoring furniture at the State Capital Building, in Lincoln.
“It stops you in your tracks, you cannot breathe,” said Dulas.
Dulas was hoping to be approved for the drug trial which includes 4 infusions over the course of a week, along with vitamin supplements and clinic visits for a year.
“To get out of the situation I’m in, I’ll do anything,” said Dulas. Who learned just days ago, because he has a pacemaker he cannot be part of the trial, but may benefit from the drug if it’s approved for use in the U.S.
If you know a person living with Complex Regional Pain Sydrome, they can contact Dr. Recker’s officer for more information on the study. The phone number is 402-280-Bone, or 402-280-2663. All expenses are covered for participants.

Original post and video found here: www.ketv.com/article/omaha-drug-trial-hopes-to-ease-pain/11644837
Last Updated when copied over: 10:47 PM CDT Aug 6, 2017 by Julie Cornell

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[Study] Cannabinoids May Treat Neuropathic Symptoms and Neuroinflammatory Responses

What are Cannabinoids

Agonists of the CB2 receptor – such as cannabis-derived cannabinoids – may provide a treatment option for neuropathic symptoms and neuroinflammatory responses, according to a new study published by the European Journal of Neuroscience. The study was e-published ahead of print by the U.S. National Institute of Health.

“Cannabinoid receptor 2 (CB2) has emerged as a promising target for treating different neuropathic pain syndromes”, states the study’s abstract. “In neuropathic pain models, activated microglia expressing CB2 receptors are seen in the spinal cord.”

With this in mind, researchers hypothesized that a CB2 agonist could “modulate neuroinflammation and neuropathic pain in an ischemia model of CRPS [complex regional pain syndrome]by regulating CB2 and CX3CR1 signaling.”

Using chronic post-ischemia pain (CPIP) as a model of CRPS, researchers used rats to determine the potential benefits of a selective CB2 agonist meant to mimic the effects of cannabinoids.

Rats in the CPIP group exhibited significant hyperemia and edema of the ischemic hindpaw and spontaneous pain behaviors (hindpaw shaking and licking), whereas “intraperitoneal administration of MDA7 (a selective CB2 agonist) attenuated mechanical allodynia induced by CPIP.”

MDA7 treatment was found to “interfere with early events in the CRPS-I neuroinflammatory response by suppressing peripheral edema, spinal microglial activation and expression of CX3CR1 and CB2 receptors on the microglia in the spinal cord. MDA7 also mitigated the loss of intraepidermal nerve fibers induced by CPIP.”

The study concludes; “Our findings suggest that MDA7, a novel CB2 agonist, may offer an innovative therapeutic approach for treating neuropathic symptoms and neuroinflammatory responses induced by CRPS-I in the setting of ischemia and reperfusion injury.”

The full study can be found by clicking here.

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NOTE: Please remember to follow the laws of your state when it comes to your pharmaceutical care. Medical cannabis is not legal in all states in all forms, so be aware of what your state limitations are.

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Enrollment of the First Patient in a Phase 3 of AXS-02

Doctor

NEW YORK, Aug. 10, 2015 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the treatment of pain and other central nervous system (CNS) disorders, today announced the enrollment of the first patient in the CREATE-1 (CRPS Treatment Evaluation 1) study—a Phase 3 trial evaluating the efficacy and safety of AXS-02 (disodium zoledronate) for the treatment of pain associated with complex regional pain syndrome (CRPS). AXS-02 is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain.

“CRPS patients live with a level of pain that is unimaginable for most of us. As there are no approved treatments for this serious disease, it represents a high unmet medical need,” said Leonardo Kapural, M.D., Ph.D., Professor of Anesthesiology at Wake Forest University, and Clinical Director of the Chronic Pain Center at Wake Forest University Health Sciences Center. “This is an important clinical trial as it may increase the treatment options for those living with CRPS.”

“The Reflex Sympathetic Dystrophy Syndrome Association (RSDSA) supports research to develop better treatments and a cure for this devastating condition,” said Jim Broatch, Executive Vice President and Director of the RSDSA. “Clinical trials such as the CREATE-1 study is an example of the type of research that could yield new options to improve the lives of individuals with CRPS.”

“We are pleased to enroll the first patient in the CREATE-1 trial,” said Randall Kaye, M.D., Chief Medical Officer of Axsome Therapeutics. “This multi-national study will further our understanding of the potential role of AXS-02 in the treatment of pain associated with CRPS. The launch of this Phase 3 trial comes on the heels of our recent FDA Fast Track designation for AXS-02 in CRPS.”

In March of this year, the United States Food and Drug Administration (FDA) granted Fast Track designation for AXS-02 for the treatment of pain associated with CRPS. This designation provides greater access to and more frequent communication with the FDA throughout the entire drug development and review process, with the goal of possibly expediting approval. Fast Track designation also gives Axsome the opportunity to potentially submit sections of the AXS-02 new drug application (NDA) for CRPS on a rolling basis, and allows AXS-02 to be considered for priority review at the time of submission. AXS-02 has also been granted Orphan Drug Designation by the FDA, and Orphan Medicinal Product Designation by the European Medicine Agency (EMA) for the treatment of CRPS.

“As an organization, we aim to research and bring to market innovative therapies for sufferers of chronic pain and CNS diseases,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome Therapeutics. “We are committed to working to find solutions for the CRPS patient community.”

About the CREATE-1 Study

This Phase 3 multi-national, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AXS-02 in the treatment of pain associated with CRPS. The study is expected to enroll 190 patients at sites in the United States, Canada, Europe, and Australia. Eligible patients will be randomized in a 1:1 ratio to be treated with AXS-02 or placebo. The primary efficacy measure is the change in patient reported pain intensity, measured using the 0-10 Numerical Rating Scale (NRS). Secondary outcome measures include assessments of the change in the Brief Pain Inventory (BPI) Pain Score, Patients’ and Clinicians’ Global Impression of Change (PGI-C and CGI-C, respectively), quality of life measures, and bone turnover markers.

More information about the CREATE-1 study is available at www.clinicaltrials.gov.

To learn about eligibility, patients can visit www.CRPStrial.com.

About AXS-02

AXS-02 (disodium zoledronate) is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain, including pain associated with CRPS. AXS-02 has a high affinity for bone mineral, and reduces osteoclast activity by inhibiting the farnesyl pyrophosphate synthase (FPPS) enzyme.

AXS-02 is an investigational medication not approved by the FDA. The safety and efficacy of AXS-02 have not yet been established.

 

Source: CRPS in the News
Announcement made: August 10, 2015 06:30 ET by Axsome Therapeutics, Inc.
(Copied as online data is not static and this should be retained, please know, all rights are to the author and original publication)

 

Tortured by pain doctors can’t explain?

PainScale

 

As a GP, Dr Nick Mann is used to seeing people in pain – and as someone who’s suffered from it for years himself, he is particularly sympathetic.

In his 20s he damaged a disc in his neck during a surfing accident, causing it to bulge or ‘slip’. Over the next 12 years, more of the discs in his neck became damaged, leaving him with chronic stinging pain in his back, arms and shoulders.

But this was nothing compared with what came next. One day Dr Mann woke up having slept in an awkward position.

From then on the slightest movement of his right arm, or even being touched on his upper back, caused waves of excruciating pain.

‘The pain intensified over several months to the point where, having been able to carry on “as normal” for 12 years despite a series of slipped discs, I became unable to lift a stethoscope to listen to someone’s chest,’ explains Dr Mann, 51, who works at an NHS surgery in East London.

‘If anyone even gently brushed against my back I would get a jolt of incredible pain and my knees would buckle.’

As well as the pain, his right hand became a mottled red colour. And, most remarkably, the nails and hair on his arm grew faster, as did the bones in his right hand – over months it grew bigger than his left hand.

His doctor gave him prescriptions for painkillers, but this did nothing.

‘There appeared to be no answers as to why this had happened,’ says Dr Mann, who lives in Hackney, East London, with wife, Karen, 48, and their children aged 14 and 11.

His doctor referred him to a neurosurgeon. ‘He treated me like a malingerer,’ recalls Dr Mann. ‘It was the most terrifying time of my life.

‘I couldn’t work and I feared I might never do so again at that point. My right arm, as well as being painful, began to lose its power. Despite trying to keep it moving, it gradually lost strength and co-ordination, until four months later it just hung uselessly by my side.

‘I could do everyday things like write and eat with a knife and fork but it was extremely hard. My wife was pregnant with our second son and she did not need another dependent at this point.’

Six months after Dr Mann’s symptoms began, an osteopath suggested the problem might be shoulder-hand syndrome – a form of complex regional pain syndrome (CRPS).

Suddenly Dr Mann realized he had a diagnosis. CRPS is a greater-than-normal reaction of the body to an injury, resulting in a ‘scalding’ pain at the slightest touch.

‘The pain is so bad that it is not uncommon for people to say they want to have their affected limb amputated,’ says Dr Andreas Goebel, a senior lecturer in pain medicine at Liverpool University.
The syndrome usually affects just one limb, commonly the  arm or leg.

Six months after his symptoms began, an osteopath suggested the problem might be shoulder-hand syndrome

As well as pain, the skin of the affected limb can change colour and may be warmer or cooler than normal. Hair and nail growth can dramatically increase or decrease (possibly as the nervous system helps regulate this growth).

In time – generally months – the limbs can become weaker and frozen in position, not only because it hurts to move them, but because it becomes physically impossible to do so.

Although the condition was first identified during the American Civil War, CRPS’s cause is as yet not fully understood. However, it’s thought to stem from a problem with the nerves, as it can occur after a major injury to a nerve.

This is referred to as CRPS type  2. It can also occur after surgery or a mild knock. Around 10  per cent of those who have a fractured limb will develop it, when it is known as CRPS type 1.

‘Just the trauma of a vaccination is enough to trigger it in some,’ says Candy McCabe, a consultant nurse at the Royal National Hospital for Rheumatic Diseases in Bath and professor of nursing and pain sciences at the University of the West of England, Bristol.

‘However, in 9 per cent of cases the condition occurs without any obvious injury,’ she says.
It may also be an autoimmune condition, suggests Dr Goebel.

‘We are looking at the possibility that with CRPS the immune system alters the way the nerves function – all the symptoms are nerve-related.

‘Nerves can secrete neuropeptides, protein-like molecules that nerve cells use to communicate with each other, and in excess these can lead to swelling and discolouration of the skin – as happens with CRPS.’ Professor McCabe adds there is no ‘absolute evidence’ of this yet.

‘What we do know is that even if it has an autoimmune component, things quite quickly get driven by the brain,’ she says.

Quite why limbs should become useless is not clear. ‘What we think happens is that people feel as if they can’t use the affected limbs and this in time alters the way the brain talks to these areas,’ says Professor McCabe. ‘This is most common among young females – their joints can become fixed in an unusual position.’

The syndrome is three times more common in women and is most common among post-menopausal women, ‘which suggests some hormonal element’, says Professor McCabe.

Physiotherapy can help keep the joint mobile, ‘but it needs to be started as soon as possible to have best effects and that depends on an early diagnosis’, she adds.

Yet although it is not an uncommon condition – affecting around 16,000 people in Britain – few doctors have heard of CRPS. ‘It’s not taught in medical schools, and many doctors will never even have heard it,’ says Professor McCabe.

‘There is no definitive test – diagnosis depends on the patients explaining their symptoms and the doctor understanding what they mean.’

Patients commonly experience a delay in diagnosis and some may be told their symptoms are in the mind, says Professor McCabe.

‘Yet it is a very real condition that can be absolutely horrific. I have seen tough miners in tears with the pain of this condition.’

In 80 per cent of cases, the condition resolves itself within a year, but for the rest, the condition can become progressively worse.

Patients commonly experience a delay in diagnosis and some may be told their symptoms are in the mind

Morphine and other strong painkillers have little effect, but nerve blocks – injections of local anaesthetic into the affected nerves – can help, as can spinal cord stimulation. This involves having a device fitted into your abdomen or buttocks that sends electrical pulses to your spinal cord, which alters how you sense pain.

This helps in around half of all patients, says Dr Goebel. He has recently completed a study using a drip of immunoglobulin (a form of antibodies used by the immune system).

In his study, published in the journal Rheumatology last year, a weekly infusion stopped the pain symptoms for two sufferers within months – even though they had been suffering from the condition for five years.

‘We expect it to be effective in a quarter of those with CRPS and if it is going to be effective it will start working straight away,’ he says.

For Dr Mann, the road to recovery after his symptoms began in 2002 was agonisingly slow. ‘I eventually saw an osteopath who was also a doctor. He thought the problem originated in my upper ribs,’ he says. ‘After the first treatment manipulating my upper ribs, the nature of the pain changed totally.’

He believes that for many people with CRPS the upper ribs may be the problem. ‘Many CRPS sufferers report an initial shoulder impact,’ he says. ‘This can send a force from the shoulder through to the ribs so that they are a bit like bent sticks.

‘When they’re compressed they can rotate slightly. Very small displacements at the spinal end of the rib can cause small but important distortion of the sympathetic trunk.’

The sympathetic trunk is a bundle of nerve fibres carrying signals which control, for example, muscle reflexes, blood flow and pain transmission. If the ribs are disturbed enough, they can put pressure on these nerves and create havoc, adds Dr Mann.

‘As my ribs were freed with osteopathy my pain reduced and my hand returned to colour pretty rapidly,’ says Dr Mann, who is now living a full and active life.

He believes his experiences made him a better doctor.

‘What happened to me gave me so much insight into how people with long-term pain suffer,’ he says. ‘They go to their GP and shuffle out with a prescription for painkillers or an appointment  to see the physiotherapist, but  these people keep coming back because no one finds out why they have this pain.

‘Our system deals with the consequences, but has stopped looking for the causes.’

 

Brought to you by LUCY ELKINS FOR MAILONLINE posted on the Daily Mail

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Source: Google CRPS in the News

 

 

Here to Help RSD’s Amazing Video

Help

Thank you to “Here to Help RSD” for creating such an amazing video that helps give a better incorporation of what we try so often explain to our family and friends but it’s not easy to really put it into words of what we are trying to fight.

[youtube=https://www.youtube.com/watch?v=CD5Hx2zDZcc&w=640&h=385]

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VECTTOR Therapy Trial To Occur in Texas

Defying Muscular Dystrophy Foundation and the Hope for Gabe Foundation will be sponsoring a double-blind, randomized, placebo-controlled trial of VECTTOR therapy for Duchenne Muscular Dystrophy in Houston, Texas, later this year. This trial will be held in cooperation with Alan Neuromedical Technologies and Dr. Donald A. Rhodes.

What is VECTTOR therapy?

VECTTOR therapy is a form of electrostimulation based upon acupuncture, reflexology, physiology, cellular physiology, and anatomy designed to stimulate the nerves to produce certain vital neuropeptides essential for optimal functioning of the body. VECTTOR therapy is non-invasive and the treatments are not painful. There are no known negative side-effects from VECTTOR therapy. However, the long-term use of electrostimulation has not been studied.

[youtube=https://www.youtube.com/watch?v=X7WB5dmOp5E&rel=0Who is eligible for this study?]

The study will include up to 12 individuals with Duchenne Muscular Dystrophy, who are 20 years old or younger and who are non-ambulatory. Further screening criteria may include steroid usage, previous study participation, and prior muscle biopsies. The exclusion criterion includes individuals with a demand type cardiac pacemaker.

What will happen during this study?

Each participant will be randomly assigned either an active or a placebo VECTTOR system. The systems are visually indistinguishable but only the active unit will administer electrostimulation.

Each study participant and/or his caretaker will be trained to properly administer the VECTTOR treatments and will be able to do so in their own home. Support staff will be available for questions or concerns throughout the duration of the study.

How long with this study last?

The study will run for six months with a possible six month extension. For the first six months, the participants will be randomly divided into two equal, blinded groups. The first group will receive active VECTTOR treatments; the second group will receive inactive (placebo) treatments. The participants will receive various testing at weeks: 0, 4, 9, 13, and 26. At the end of the six month period, if the testing shows improvement in those participants receiving active treatment; all participants will receive active treatment for the 6 months extension and all testing will be repeated at the end of the second six months.

What will be required of the participants?

Each participant will be required to report to the testing center(s) in or around the greater Houston area at least 6 times, prior to, and throughout the duration of the study. Participants will be expected to administer VECTTOR therapy treatments twice per day for the first month and at least once per day for the remainder of the study. The units are equipped with tracking software to demonstrate compliancy and to collect treatment data.

Treatment data will be collected on an SD card installed in the VECTTOR system which will be downloaded, by the participants, to the study coordinator.

All testing will be done in or around the greater Houston area.

Is there payment for participation?

There is no payment for participation, nor reimbursement for travel expenses. However, participants will be provided with all equipment, supplies and testing at no cost to them.

What testing will be performed?

Muscle strength testing and joint range of motion testing will be performed prior to beginning VECTTOR therapy and again at weeks: 4, 9, 13, and 26. If there is an extension phase of the study, the same testing will be repeated at the end of the second six months.

The presence of Deep Tendon Reflexes will be assessed prior to beginning treatment and again at weeks: 4, 9, 13, and 26. Provided there is a study extension, this test will be repeated at the end of the second six months.

Bone mineral densities will be obtained prior to beginning treatment and again at 26 weeks. Provided there is a study extension, this test will be repeated at the end of the second six months.

Physiological sleep studies will be obtained twice before beginning the study. The second study will be used as the baseline test. A follow up study will be obtained at week 26. If there is a study extension, this test will be repeated at the end of the second six months.

Echocardiograms will be obtained prior to beginning treatments, and again at week 26. Provided there is a study extension, this test will be repeated at the end of the second six months.

Pulmonary function testing will be obtained prior to beginning treatment and again at week 13 and week 26. Provided there is a study extension, this test will be repeated at the end of the second six months.

Eligible participants should contact VECTTORtrial@gmail.com or call the study coordinator at (713) 734-4433 for more information.

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