Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Methylphenidate Hydrochloride as a Treatment for Chronic Fatigue Syndrome in Patients Taking a CFS-Specific Nutrient Formula
试验速览
- 阶段
- 2 期
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Change in patient reported Checklist Individual Strength (CIS) Total Score
研究概览
简要总结
The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate hydrochloride) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).
详细描述
The Synergy Trial will evaluate the safety and efficacy of a currently available medication (methylphenidate) combined with a CFS-specific dietary supplement (CFS Nutrient Formula) to treat Chronic Fatigue Syndrome (CFS).
The CFS Nutrient Formula to be used in this trial is a broad-spectrum micronutrient supplement that provides CFS patients with vitamins, minerals, and other cofactors (amino acids, antioxidants, and mitochondrial cofactors) to complement the low-dose Central Nervous System (CNS) stimulant (methylphenidate). In other words, therapeutic dosages of micronutrients are provided to support the functioning of the nervous, endocrine, and immune systems to a level at which a lower than customary dosage of methylphenidate can produce positive clinical effects on CFS symptoms and also be well tolerated.
Methylphenidate is the generic form of Ritalin®. The dose being tested in this study is relatively low (5-10mg twice daily). This drug has been in clinical use for over 50 years for the treatment of Narcolepsy and Attention Deficit Disorder and has a well-described safety profile when used as recommended. Methylphenidate alone has been studied as a treatment for CFS in the past and has been shown to produce mild benefits and be well-tolerated. When provided as innovative therapy, methylphenidate plus this CFS Nutrient Formula has produced substantial improvements in CFS symptoms in a limited number of patients, and demonstrated excellent tolerability.
Use of low dose methylphenidate hydrochloride coadministered with a CFS Nutrient Formula has not been previously evaluated in a controlled clinical study. The risk to patients using this combination is believed to be low, especially in the context of a well-controlled clinical study. Furthermore, this combination is not expected to increase the incidence or severity of adverse events associated with methylphenidate hydrochloride.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fulfill the 1994 CDC case definition of CFS (Fukuda et al., Ann Intern Med. 1994; 121:953-959)
- •Subjects must also report alertness and/or concentration deficits
- •Otherwise in good health based on medical history and screening evaluation
- •Willingness to NOT take any nutritional or herbal supplements other than the study treatment during the course of the trial
- •Nutritional supplements that are exempted from this requirement are limited to the following:
- •Probiotic supplements
- •Fiber supplements
- •Fish oil supplements
- •Digestive enzymes
- •Melatonin ≤ 10mg per day
- •Calcium ≤ 600 mg per day
- •Magnesium ≤ 400 mg per day
- •Vitamin D ≤ 400 i.u. per day
- •Willingness to NOT consume any caffeine-containing supplements during the study period (coffee, tea, or chocolate are exempt). These include but are not limited to the following beverages:
- •Red Bull®
- •Rockstar®
- •5-hour® energy shots
- •Willingness to NOT consume any pseudoephedrine-containing products during the study period
- •Willingness to practice effective contraception
排除标准
- •Pregnancy or lactation
- •Active substance abuse
- •Major depression as defined by Zung Depression Scale score ≥ 60
- •Use of rintatolimod (Ampligen®) within the past 3 months
- •Currently taking any prescription medication to treat anxiety on a daily basis
- •Use of more than 3 times/week within the past 3 months of:
- •Monoamine oxidase inhibitors (MAOs)
- •Anti-psychotic medications
- •CNS stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, amphetamines)
- •Narcotic opioids
- •Tramadol (i.e. Ultram®, Ultracet®, Conzip®, or Ryzolt®)
- •Gabapentin (Neurontin®) > 600mg/day
- •Pregabalin (Lyrica®)
- •Duloxetine (Cymbalta®)
- •Milnacipran (Savella®)
- •Coumarin anticoagulants (Coumadin®)
- •Valganciclovir (Valcyte®)
- •Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are:
- •Amitriptyline ≤ 30mg at bedtime
- •Trazodone ≤ 50mg at bedtime
- •Doxepin ≤ 20mg at bedtime
- •Active medical conditions to which treatment with methylphenidate hydrochloride or micronutrients may be contraindicated, including:
- •Diabetes Mellitus
- •Current stomach or duodenal ulcer
- •Uncontrolled hypertension (blood pressure at screening of systolic >150 or diastolic >90)
- •Heart disease (including cardiac arrhythmia, cardiac ischemia, syndrome of Gilles de la Tourette or a past history of myocardial infarction or cerebrovascular event)
- •Motor tics or family history of psychosis or bipolar disorder
- •Previous history or seizures
- •A diagnosis of other conditions that may be in part responsible for the patient's fatigue including, but not limited to:
- •HIV infection
- •Chronic Hepatitis B & C
- •Cancer (receiving treatment either currently or within the past two years)
- •Chronic Renal Disease
- •Clinically significant laboratory test values as determined by the Investigator
- •Clinically significant ECG abnormalities as determined by the Medical Monitor
- •Compliance criteria: A subject will not be eligible if he/she, in the opinion of the Investigator, will be unable to comply with any aspect of this study protocol, including the visit schedule.
研究组 & 干预措施
Methyl-P plus Nutrient Formula
Methylphenidate hydrochloride plus a CFS Nutrient Formula, both taken twice daily.
The CFS Nutrient Formula is a broad-spectrum CFS-specific dietary supplement that provides CFS patients with cellular fuel and cofactors (amino acids, antioxidants, and mitochondrial cofactors) while the low-dose CNS stimulant (methylphenidate hydrochloride) provides a metabolic catalyst to enhance cellular metabolism.
干预措施: Methyl-P plus Nutrient Formula (Drug)
Methyl-P plus Nutrient matched placebos
Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily.
干预措施: Methyl-P plus Nutrient matched placebos (Drug)
结局指标
主要结局
Change in patient reported Checklist Individual Strength (CIS) Total Score
时间窗: Week 12
次要结局
- Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)(Week 12)
- Number of Participants with Adverse Events to Assess Safety and Tolerability(Week 12)
- Fatigue Score by Visual Analog Scale (VAS)(Week 12)
- Concentration Disturbances Subscore on the CIS(Week 12)
- Percentage of patients with 20% or greater improvement in the CIS total score(Week 12)
- Concentration Disturbances Score by Visual Analog Scale (VAS)(Week 12)
- Pain Symptoms by Brief Pain Inventory Form(Week 12)