Archived | Autism Speaks: Clinical Trials Network | Circa 2007 #NotAnAutisticAlly


Clinical Trials Network

Fluoxetine Study
Memantine Study

Autism Speaks’ Clinical Trials Network (CTN) was officially launched in 2005 by Cure Autism Now to focus on translational research, the critical step necessary to transfer findings from the laboratory to clinical application. Well controlled and appropriately blinded studies are needed to test whether anecdotal evidence holds. By facilitating data-sharing and multi-center trials, the goal of the network will be to test the efficacies of treatment approaches as well as to rapidly screen new promising compounds that emerge from biomedical research, significantly decreasing the time and amount of money needed to develop them.

Frequently Asked Questions About CTN
General Information About Clinical Trials



CTN Trial: Study of Fluoxetine in Autism (SOFIA
Sponsor: Neuropharm Group Plc 

The Study of Fluoxetine in Autism (SOFIA) represents the CTN’s first industry-sponsored trial, and will include more than 100 children and adolescents with Autism Spectrum Disorders (ASD) enrolled across the country at the participating CTN sites.

The goal of study is to confirm the effectiveness of Neuropharm’s custom-designed product NPL-2008, a proprietary preparation of fluoxetine, in reducing certain core symptoms of ASD. This new formulation will feature autism-specific doses in a melt-in-the-mouth formulation designed specifically for those with ASD. 

Fluoxetine, one of the most widely prescribed central nervous system (CNS) drugs, is a selective serotonin reuptake inhibitor (SSRI) often prescribed to treat depression, anxiety, obsessive-compulsive disorder and other CNS disorders. Fluoxetine is designed to increase serotonin levels in the brain and may therefore address symptoms related to abnormal levels of serotonin observed in individuals with ASD. 

The SOFIA trial follows positive results from earlier Phase II and Phase III studies of fluoxetine in children and adults with autism, conducted by Professor Eric Hollander at Mount Sinai School of Medicine in New York. 

Current List of Participating Sites:

Eastern Region:
Harvard University/Cambridge Health Alliance
Long Island Jewish Hospital
Mount Sinai School of Medicine (MSSM)
University of Medicine and Dentistry of New Jersey (UMDNJ)
University of North Carolina (UNC)
University of Pittsburgh/Children’s Hospital
Yale University

Midwest:
Ohio State University (OSU)
University of Illinois, Chicago

West/Southwest:
Seattle Children’s Hospital 
Southwest Autism Research and Resource Center (SARRC)
University of California, Davis

Frequently Asked Questions About ithe SOFIA Study
Read the Press Release Here

CTN Trial: Memantine

Through a Treatment Initiative Award given to Evdokia Anagnostou, M.D. in 2005, Cure Autism Now sponsored the first CTN clinical trial, which evaluated the effects of memantine (marketed as Namenda) on motor skills and expressive language in autism. Memantine is a glutamate antagonist that is an FDA-approved pharmaceutical for treatment of memory loss in moderate to severe Alzheimer’s disease. CTN will be conducting a double-blind, placebo-controlled trial of 60 children with ASD to formally examine the benefit of memantine in motor planning and expressive language. While the preliminary data strongly support the rationale for a trial, the formal methodology must be used if memantine is to ever be considered effective by traditional medical standards.
(Research Partner: Sallie and Tom Bernard)

Current List of Participating Sites 

The following sites are participating in the memantine trial: 

Mount Sinai School of Medicine, NY, NY: Evdokia Anagnostou, M.D.
North Shore-Long Island Jewish Health System, Long Island, NY: Joel Bregman, M.D.
University of Medicine and Dentistry of New Jersey (UMDNJ), Newark, NJ: Charles Cartwright, MD
Southwest Autism Research and Resource Center (SARRC), Phoenix, AZ: Raun Melmed, M.D.
University of North Carolina, Chapel Hill, NC: Lin Sikich, M.D.
Yale Child Study Center, New Haven, CT: Lawrence Scahill, MSN, Ph.D.
Ohio State University, Columbus, OH: Michael Aman, Ph.D.
University of Washington, Seattle, WA; Bryan King, M.D., Ph.D.


Frequently Asked Questions About the Clinical Trials Network

  1. What is the Clinical Trials Network?

The Clinical Trials Network is a network of 8-13 medical centers collaborating on clinical trials for autism. The centers in the network collaborate on a single trial with each site recruiting children for the trial (multi-site, single protocol trial). This means that recruitment goals can be met faster, decreasing the amount of time it takes to complete a trial to screen and develop new treatments. Since the sites in the network share uniform practices for data collection, assessment training, and study methods, getting studies started is also greatly expedited.

  1. When was the Clinical Trials Network started?

The Clinical Trials Network was developed by Cure Autism Now in late 2005 through a grant to Dr. Eric Hollander at Mount Sinai School of Medicine. 

  1. Will the Clinical Trials Network only study pharmaceuticals?

No. The goal of the CTN is to do well-controlled scientific studies of viable treatments including pharmaceuticals, neutraceuticals (vitamins etc.), and behavioral treatments.

  1. How can I get a trial in my area?

Sites are added according to their commitment to do clinical trials for autism and their ability to successfully conduct trials. Families can interest their local medical center in potential trials by telling their doctor about the network.


General Information on Clinical Trials

This information is from http://www.clinicaltrials.gov/

  1. What is a clinical trial?


Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators. 

  1. Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. 

  1. Who can participate in a clinical trial?


All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

  1. What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

  1. What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

  1. What are the benefits and risks of participating in a clinical trial?

Benefits
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks
There are risks to clinical trials.

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
  1. What are side effects and adverse reactions?

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

  1. How is the safety of the participant protected?

The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports. (See Confidentiality Regarding Trial Participants)

  1. What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

  • What is the purpose of the study?
  • Who is going to be in the study?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • How long will the trial last?
  • Will hospitalization be required?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?
  1. What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
  • Plan ahead and write down possible questions to ask.
  • Ask a friend or relative to come along for support and to hear the responses to the questions.
  • Bring a tape recorder to record the discussion to replay later.

Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

  1. Does a participant continue to work with a primary health care provider while in a trial?

Yes. Most clinical trials provide short-term treatments related to a designated illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol.

  1. Can a participant leave a clinical trial after it has begun?

Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

  1. Where do the ideas for trials come from?

Ideas for clinical trials usually come from researchers. After researchers test new therapies or procedures in the laboratory and in animal studies, the experimental treatments with the most promising laboratory results are moved into clinical trials. During a trial, more and more information is gained about an experimental treatment, its risks and how well it may or may not work. 

  1. Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices, or community clinics.

  1. What is a protocol?


A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.

  1. What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

  1. What is a control or a control group?

A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.


Frequently Asked Questions: SOFIA Study

  1. How can I find out more about participating in the study?

Many of the study sites are enrolling participants. Interested parents can email their contact information (name, phone, email address, area where you live) to sofiastudy@arkios.com or to Nancy Jones, Ph.D. at njones@autismspeaks.org. If your site is not yet enrolling, you can be put on an “interest list” to be contacted when the site is ready to enroll. Sites may also post an announcement on the Autism Speaks web-based research study list, Parents as Partners, as well as on the IAN web site. If you don’t see a posting for a site in your area, or aren’t sure where to start, please contact Nancy Jones or sofiastudy@arkios.com.


IAN screenshot

Caption:

What is the IAN Project?IAN, the Interactive Autism Network, is an innovative online project designed to accelerate the pace of autism research by linking researchers and families. Anyone impacted by an Autism Spectrum Disorder (ASD) can become part of IAN’s online community to stay informed about autism research, provide feedback, and make their voices heard.

In addition, families of children with an ASD can share information in a secure online setting and become part of the nation’s largest online research effort. As a result, researchers will obtain valuable data, explain findings, and collaborate with families and one another. This dynamic exchange could lead to new discoveries about causes, diagnosis, treatments, and a possible cure for this puzzling group of disorders.

  1. What is fluoxetine?

Fluoxetine, one of the most widely prescribed central nervous system (CNS) drugs, is a selective serotonin reuptake inhibitor (SSRI) often prescribed to treat depression, anxiety, obsessive-compulsive disorder and other CNS disorders. Fluoxetine is designed to increase serotonin levels in the brain and may therefore address symptoms related to abnormal levels of serotonin observed in individuals with ASD.

  1. Isn’t fluoxetine another name for Prozac®?

Fluoxetine is the name of the drug compound (generic name). It has been marketed under the brand name Prozac®. The current study is using a new formulation of the drug. This formulation is a proprietary preparation of fluoxetine, featuring autism-specific dosages in a melt-in-the-mouth formulation designed specifically for children and adults with ASD.

  1. Fluoxetine has already been in use by doctors for autistic patients. Why is it important for us to study this drug instead of something new?

Fluoxetine is a drug that has been indicated for use for the treatment of depression, anxiety, obsessive-compulsive disorder and other CNS disorders. 

Because of this, it has long safety record in both adult and pediatric populations. Many doctors, using their clinical judgment, prescribe the medicine to children and adolescents with autism to relieve autistic symptoms (this is called an “off-label” use). While the existing clinical data is positive, there have been relatively few well-controlled double-blind studies (studies that include a group taking active medicine and a comparison group taking a placebo, or inactive sugar pill) of the effects of the drug in children and adolescents with autism. This new formulation features autism-specific dosages in a melt-in-the-mouth format designed specifically for children and adults with ASD. This study aims to measure the efficacy of the drug in reducing specific autistic symptoms. 

  1. Who is Neuropharm?

Neuropharm Group Plc is a specialty pharmaceutical company focused on the development of products for the treatment of disorders of the central nervous system (CNS). 

You can find more information on the Neuropharm at www.neuropharm.co.uk.


Autism Speaks

#NotAnAutisticAlly

An Autism Speaks Initiative
Interactive Autism Network (IAN)
MSSNG
Cure Autism Now
Autism Clinical Trials Network (ACTN)
Autism Genetic Resource Exchange (AGRE)
Autism TIssue Program (ATP)
National Alliance for Autism Research (NAAR)
Autism Treatment Network (ATN)
Autism Intervention Research Network on Physical Health (AIR-P)
Autism Care Network
Alpha Xi Delta
Parents As Partners



Note/Warning:

Autistic people have fought the inclusion of ABA in therapy for us since before Autism Speaks, and other non-Autistic-led autism organizations, started lobbying legislation to get it covered by insurances and Medicaid. 

ABA is a myth originally sold to parents that it would keep their Autistic child out of an institution. Today, parents are told that with early intervention therapy their child will either be less Autistic or no longer Autistic by elementary school, and can be mainstreamed in typical education classes. ABA is very expensive to pay out of pocket. Essentially, Autism Speaks has justified the big price tag up front will offset the overall burden on resources for an Autistic’s lifetime. The recommendation for this therapy is 40 hours a week for children and toddlers.

The original study that showed the success rate of ABA to be at 50% has never been replicated. In fact, the study of ABA by United States Department of Defense was denounced as a failure. Not just once, but multiple times. Simply stated: ABA doesn’t workIn study after repeated study: ABA (conversion therapy) doesn’t work. 

What more recent studies do show: Autistics who experienced ABA therapy are at high risk to develop PTSD and other lifelong trauma-related conditions. Historically, the autism organizations promoting ABA as a cure or solution have silenced Autistic advocates’ opposition. ABA is also known as gay conversion therapy.


The ‘cure’ for Autistics not born yet is the prevention of birth. 

The ‘cure’ is a choice to terminate a pregnancy based on ‘autism risk.’ The cure is abortion. This is the same ‘cure’ society has for Down Syndrome. 

This is eugenics 2021. Instead of killing Autistics and disabled children in gas chambers or ‘mercy killings’ like in Aktion T4, it’ll happen at the doctor’s office, quietly, one Autistic baby at a time. Different approaches yes, but still eugenics and the extinction of an entire minority group of people.


Fact: You can’t cure Autistics from being Autistic.

Fact: You can’t recover an Autistic from being Autistic.

Fact: You can groom an Autistic to mask and hide their traits. Somewhat. … however, this comes at the expense of the Autistic child, promotes Autistic Burnout (this should not be confused with typical burnout, Autistic Burnout can kill Autistics), and places the Autistic child at high risk for PTSD and other lifelong trauma-related conditions.


[Note: Autism is NOT a disease, but a neurodevelopmental difference and disability.]


Fact: Vaccines Do Not Cause Autism.


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