Clinical Trials in Chronic Fatigue Syndrome

Condition: Chronic Fatigue Syndrome, Fibromyalgia, Irritable Bowel Syndrome
Intervention:
Location: Birmingham

Condition: Chronic Fatigue Syndrome
Intervention: The purpose of this study is to have a lumbar puncture
Location: Washington, D.C.

Condition: Somatoform Disorders; Fibromyalgia; Myofascial Pain Syndrome, Diffuse; Depression; Chronic Fatigue Syndrome
Location: Ulm, Germany

Condition: Chronic Fatigue Syndrome
Intervention:
Location: Iowa City, IA

Condition: Chronic Fatigue Syndrome
Intervention:
Location: Ann Arbor, MI

Condition: Chronic Fatigue Syndrome
Intervention:
Location: St. Louis, MO

Condition: Chronic Fatigue Syndrome
Intervention: The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome.
Location: Durham, N.C.

Condition: Chronic Fatigue Syndrome
Intervention: The purpose of this study is to determine the safety and efficacy of duloxetine compared with placebo for reducing fatigue in patients diagnosed with Chronic Fatigue Syndrome (CFS)
Location: Cincinnati, OH

Condition: Chronic Fatigue Syndrome
Intervention: Drug: L-NMMA trimethaphan, Drug: methyldopa
Location: Nashville, TN

Condition: Fibromyalgia; Irritable Bowel Syndrome; Fatigue Syndrome, Chronic
Intervention:
Location: Seattle, WA

Clinical Trials in Fibromyalgia (FM)

Condition: Fibromyalgia
Intervention: Device: Transcranial direct current stimulation
Location: Antwerp

Conditions: Fatigue Syndrome, Chronic;   Fibromyalgia;   Arthritis,  Rheumatoid
Interventions: Drug: citalopram;   Drug: 1 ml 0.9 % NaCl
Location: Antwerp

Conditions: Fibromyalgia;   Whiplash;   Chronic Pain
Interventions: Behavioral: Relaxation session;   Behavioral: Neurocognitive test battery
Location: Brussels

Condition: Fibromyalgia
Intervention: Behavioral: walking program, resistance muscular exercise
Location: São Paulo

Condition: Fibromyalgia
Intervention: Drug: quetiapine, Drug: placebo
Location: Sherbrooke, Quebec

Condition: Fibromyalgia
Intervention: Behavioral: Plurifocal educational program; Behavioral: Information
Location: Paris

Condition: Fibromyalgia
Intervention: Other: Transcranial stimulation
Location: Marseille

Condition: Fibromyalgia; Irritable Bowel Syndrome; Burning Mouth Syndrome
Intervention: Device: Repetitive transcranial magnetic stimulation
Location: Boulogne

Condition: Somatoform Disorders; Fibromyalgia; Myofascial Pain Syndrome, Diffuse; Depression; Chronic Fatigue Syndrome
Location: Ulm, Germany

Condition: Fibromyalgia; Irritable Bowel Syndrome
Intervention: Behavioral: Experimental heat pain model
Location: Mannheim, Germany

Condition: Fibromyalgia
Intervention: Drug: Tetrahydrocannabinol; Drug: Placebo
Location: Jerusalem, Israel

Condition: Fibromyalgia
Intervention: Drug: etoricoxib
Location: Kfar-Saba, Israel

Condition: Fibromyalgia
Intervention:
Location: Tel Aviv, Israel

Condition: Fibromyalgia
Intervention: Other: Evaluation of autonomic parameters
Location: Tel Aviv, Israel

Condition: Fibromyalgia; Cognitive Impairment
Location: Zrifin, Israel

Condition: Fibromyalgia
Intervention: Drug: Pregabalin
Location: Yotukaidou, Chiba, Japan (20 other locations)

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Pregabalin
Location: Nagoya, Aichi, Japan (24 other locations)

Condition: Fibromyalgia, Primary; Fibromyalgia, Secondary
Intervention: Drug: Duloxetine; Drug: Placebo
Location: Guadalajara, Merida, Monterrey and Morelia

Condition: Fibromyalgia
Intervention: Behavioral: Self-management program
Location: Lillehammer, Oppland

Condition: Fibromyalgia
Intervention: Drug: amitriptyline; Drug: quetiapine
Location: Granada

Condition: Fibromyalgia
Intervention: Drug: Milnacipran
Location: Geneve

Condition: Fibromyalgia (12 Years to 16 Years)
Intervention: Drug: placebo; Drug: pregabalin
Location: Taipei

Condition: Fibromyalgia
Intervention: Drug: mirtazapine; Drug: placebo
Location: Bangkoknoi, Bangkok

UNITED STATES TRIALS for Fibromyalgia

• Alabama
• California
• Connecticut
• District of Columbia
• Florida
• Georgia
• Illinois
• Indiana
• Iowa
• Kentucky
• Maryland
• Massachusetts
• Michigan

• Mississippi
• Missouri
• New Jersey
• New York
• North Carolina
• Ohio
• Oregon
• Pennsylvania
• South Carolina
• Tennessee
• Utah
• Virginia
• Washington

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Tuscaloosa

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Tuscaloosa

Condition: Fibromyalgia, Irritable Bowel Syndrome, Chronic Fatigue Syndrome
Intervention:
Location: Birmingham

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Beverly Hills, Los Angeles, Santa Ana

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Beverly Hills, Santa Ana

Condition: Fibromyalgia
Intervention: Drug: T3
Location: Stanford

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Sacramento

Condition: Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome
Location: Los Angeles, Stanford

Condition: Irritable Bowel Syndrome (IBS); Functional Abdominal Pain; Fibromyalgia; Complex Regional Pain Syndrome (CRPS); Myofacial Pain; Chronic Daily Headaches; Migraine Headaches; Chronic Pain
Intervention: Behavioral: Mentorship
Location: Los Angeles

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Cromwell, CT - Danbury, CT

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Hartford, CT

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Hartford, CT

Condition: Chronic Fatigue Syndrome; Fibromyalgia; Gulf War Illness; Multiple Chemical Sensitivity; Interstitial Cystitis;
Intervention:
Location: Washington, DC

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Delray Beach, Miami, Orlando, St. Petersburg, FL

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Delray Beach, Miami, Orlando, St. Petersburg, FL

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Delray Beach, Ocala, Orlando, St. Petersburg, Tampa, FL

Condition: Fibromyalgia
Intervention: Drug:
Location: Miami, FL

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Columbus, Duluth, Lawrenceville, GA

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Columbus, Duluth, Lawrenceville, GA

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Atlanta, GA

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Chicago, IL

Condition: Fibromyalgia
Intervention:
Location: Chicago, IL

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Evansville, IN

Condition: Fibromyalgia
Intervention: Other: CBT and milnacipran; Behavioral: CBT with a placebo; Drug: Educational with milnacipran
Location: Indianapolis, IN

Condition: Fibromyalgia
Intervention: Device: Transient Placebo TENS (Rehabilicare Maxima TENS); Device: Active TENS (Rehabilicare Maxima TENS); Device: No TENS (Rehabilicare Maxima TENS)
Location: Iowa City, IA

Condition: Fibromyalgia
Intervention:
Location: Iowa City, IA

Condition: Fibromyalgia
Intervention: Behavioral: Coping Skills Training; Behavioral: Education
Location: Louisville, KY

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Louisville, KY

Condition: Fibromyalgia
Intervention: Drug: Neurotropin
Location: Bethesda, MD

Condition: Fibromyalgia
Intervention: Behavioral: Lifestyle physical activity (LPA); Behavioral: Fibromyalgia education
Location: Baltimore, MD

Condition: Fibromyalgia
Intervention:
Location: Bethesda, MD

Condition: Fibromyalgia
Intervention:
Location: Ann Arbor, MI

Condition: Fibromyalgia
Intervention: Other: Traditional Acupuncture; Other: Sham Treatment
Location: Ann Arbor, MI

Condition: Fibromyalgia
Intervention: Drug: milnacipran, then placebo; Drug: Placebo, then milnacipran
Location: Ann Arbor, MI

Condition: Fibromyalgia
Intervention:
Location: Ann Arbor, MI

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Jackson, MS

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: St. Louis, MO

Condition: Fibromyalgia
Intervention:
Location: St. Louis, MO

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Livingston, NJ

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Livingston, NJ

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Willingboro, NJ

Condition: Fibromyalgia
Intervention: Drug: cyclobenzaprine ER (AMRIX); Drug: placebo
Location: Syracuse, NY

Condition: Fibromyalgia
Intervention: Drug: Duloxetine; Procedure: Skin biopsy
Location: Albany, NY

Condition: Fibromyalgia
Intervention: Device: Brand name mattress; Device: Comparison mattress
Location: New York, NY

Condition: Fibromyalgia
Intervention: Drug: Milnacipran; Procedure: Skin biopsy
Location: Albany, NY

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Syracuse, NY

Condition: Fibromyalgia
Intervention: Drug: Minalcipran; Drug: Placebo
Location: New York, NY

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Charlotte & Durham, NC

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Charlotte & Durham, NC

Condition: Fibromyalgia
Intervention: Behavioral: Cognitive behavioral therapy for insomnia; Behavioral: Pseudo-desensitization procedure; Other: Usual care
Location: Durham, NC

Condition: Fibromyalgia
Intervention:
Location: Charlotte, NC

Condition: Fibromyalgia
Intervention: Behavioral: Coping Skills Training; Behavioral: Education
Location: Cincinnati & Cleveland, OH

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Akron, Cincinnati, Columbus, OH

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Akron, Cincinnati, Columbus, OH

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Cincinnati, Cleveland, OH

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Medford, OR

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Philadelphia, PA

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Philadelphia, PA

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Mechanicsburg, PA

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Myrtle Beach, SC

Condition: Fibromyalgia, Depression
Intervention: Device: Neotonus model 2100 xxx
Location: Charleston, SC

Condition: Fibromyalgia, Depression
Intervention: Drug: pregabalin
Location: Myrtle Beach, SC

Condition: Fibromyalgia, Depression
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Greer, SC

Condition: Arthritis; Osteoarthritis; Rheumatoid Arthritis; Fibromyalgia
Intervention: Behavioral: Multicomponent exercise; Behavioral: Nutrition
Location: Columbia, SC

Condition: Fibromyalgia
Intervention: Drug: quetiapine; Drug: Placebo
Location: Johnson City, TN

Condition: Fibromyalgia
Intervention: Drug: placebo; Drug: pregabalin
Location: Salt Lake City, UT

Condition: Fibromyalgia; Obesity
Intervention: Behavioral: Lifestyle Modification; Behavioral: Supportive education
Location: Salt Lake City, UT

Condition: Fibromyalgia
Intervention: Drug: pregabalin
Location: Salt Lake City, UT

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Salt Lake City, UT

Condition: Fibromyalgia
Intervention: Device: Device: cranial electrical stimulation (CES) device (Alpha-Stim); Device: sham device
Location: Charlottesville, VA

Condition: Fibromyalgia
Intervention: Drug: Placebo; Drug: Milnacipran
Location: Bellevue, WA

Condition: Fibromyalgia; Irritable Bowel Syndrome; Fatigue Syndrome, Chronic
Intervention:
Location: Seattle, WA

Condition: Fibromyalgia
Intervention: Device: Sham rTMS
Location: Seattle, WA

Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever.

Drug and device testing begins with extensive laboratory research which can involve years of experiments in animals and human cells. If the initial laboratory research is successful, researches send the data to the Food and Drug Administration (FDA) for approval to continue research and testing in humans.

Once approved, human testing of experimental drugs and devices can begin and is typically conducted in four phases. Each phase is considered a separate trial and, after completion of a phase, investigators are required to submit their data for approval from the FDA before continuing to the next phase.

Phase I Studies

Assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.

Phase II Studies

Test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.

Phase III Studies

Involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.

Phase IV Studies

Often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage:

1. To compare a drug with other drugs already in the market.

2. To monitor a drug's long-term effectiveness and impact on a patient's quality of life; and

3. To determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies.

Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.

Funding for clinical research comes from the federal government such as the National Institutes of Health, the Department of Defense, the Department of Veteran's Affairs, and private industry such as pharmaceutical and biotech companies, medical institutions, and foundations.

When considering volunteering for a clinical trial, it is important to make an informed decision. Below are answers to frequently asked questions that many potential volunteers have about participating in a study.

• What is a clinical trial
• Who can participate in a clinical trial
• How does a clinical trial work
• What questions should be asked before choosing to participate
• What can volunteers expect if they choose to participate
• What is informed consent
• What are the benefits and risks of joining a trial
• Does information remain confidential and private
• What happens after the trial

What is a clinical trial?

A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. These treatments are developed by pharmaceutical and biotechnology companies who select qualified physicians, also known as investigators, to conduct clinical trials to determine the benefits of investigational drugs.

Clinical trials are usually conducted in three phases (I, II, III). Only a small number of people participate in phase I trials while the later phases involve a larger number of volunteers.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Before joining a clinical trial, a volunteer must qualify for the study. The factors that allow volunteers to participate in a clinical trial are called "inclusion criteria" and the factors that disallow volunteers from participating are called "exclusion criteria." These criteria can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.

Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants' safety, and ensure that researchers learn the information they need.

How does a clinical trial work?

In a clinical trial, a volunteer is usually assigned a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers may receive a placebo or a treatment already available.

A placebo is an inactive product used to assess the experimental treatment's effectiveness. The participant, physician, and research staff may not know which volunteer receives a placebo and which receives the active treatment. Not knowing which participants are receiving the active treatment allows the physician and research staff to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, however, the level of medical attention and care that each receives is the same.

What questions should be asked before choosing to participate?

Patients considering participating in a clinical trial should talk about it with their physicians and medical caregivers. Potential volunteers should also understand the credentials and experience of the staff and the facility involved in conducting the study.

Questions to ask a physician or medical caregiver:

• How long will the trial last?
• Where is the trial being conducted?
• What treatments will be used and how?
• What is the main purpose of the trial?
• How will patient safety be monitored?
• Are there any risks involved?
• What are the possible benefits?
• What are the alternative treatments besides the one being tested in the trial?
• Who is sponsoring the trial?
• Do I have to pay for any part of the trial?
• What happens if I am harmed by the trial?
• Can I opt to remain on this treatment, even after termination of the trial?

What can volunteers expect if they choose to participate?

In some studies, participants receive a physical examination and their medical histories are reviewed by either the study physician or a research staff member once they are enrolled in the study. The volunteers' health will continue to be monitored during and after the trial. A detailed description of what's expected of volunteers will be outlined in consent forms along with specific clinical trial information.

What are the benefits and risks of joining a trial?

Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. However, there are risks involved.

Possible benefits for volunteers:

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

Possible risks for volunteers:

• There may be unpleasant, serious, or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective.
• The protocol may require more time and attention than a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.

Please note: volunteers may withdraw from a study at any time for any reason.

Does information remain confidential and private?

Access to personal information is usually available to the investigator and research team conducting the clinical trial. In some circumstances, the IRB overseeing the research and the sponsor or contract research organization coordinating the trial will also have access to personal information. This is explained more specifically in the consent form that participating volunteers are asked to sign. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies.

What happens after the trial?

After a study phase is complete, the data is collected to determine the drug's effectiveness, if it is safe and if there are any side effects. Depending on the results, researchers then determine whether to stop testing or move to the next phase of study. After phase III of a study is complete, researchers decide if the results are medically important and may submit them to journals for peer-review. Data then may be submitted to the Food and Drug Administration (FDA) for approval.

If a drug is approved, pharmaceutical companies may continue to conduct studies that compare the new drug - in terms of its safety, effectiveness, and cost - to other drugs already on the market or assess a drug's long-term effectiveness and its impact on the quality of a person's life.