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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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)

 

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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