Chronic Fatigue Syndrome (CFS)Phase 2NCT01966276
The Synergy Trial: Methylphenidate Plus a CFS-Specific Nutrient Formula as a Treatment for Chronic Fatigue Syndrome
A Phase 2 study testing Methyl-P plus Nutrient Formula in people with Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME), run by K-PAX Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME)
- What is being tested?
- Methyl-P plus Nutrient Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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®
- Monster®
- Rockstar®
- 5-hour® energy shots
- Willingness to NOT consume any pseudoephedrine-containing products during the study period
- Willingness to practice effective contraception
Who cannot join
- 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:
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- 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:
- Glaucoma
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Nova Southeastern University
Fort Lauderdale, Florida, 33328
Susan Levine, MD
New York, New York, 10021
Fatigue Consultation Clinic
Salt Lake City, Utah, 84102
Stanford Chronic Fatigue Syndrome/ME Initiative
Stanford, California, 94305
About this study
Official title: 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
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).
Read the detailed description
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.
- Being tested
- Methyl-P plus Nutrient Formula, Methyl-P plus Nutrient matched placebos
- Keywords
- Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME), central nervous system (CNS), fatigue, alertness, brain fog, mitochondria, methylphenidate, Ritalin, stimulant, multivitamin, multimineral, micronutrients, supplements
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue, Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl-P plus Nutrient FormulaDrug
Also called Ritalin
- Week 1 (take the following together twice a day-at breakfast and lunch)
- One tablet of Methyl-P (5mg)
- Four tablets of CFS Nutrient Formula
- Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):
- Two tablets of Methyl-P (10mg)
- Four tablets of CFS Nutrient Formula
Methyl-P plus Nutrient matched placebosDrug
- Week 1 (take the following together twice a day-at breakfast and lunch)
- One tablet of Methyl-P Placebo
- Four tablets of CFS Nutrient Placebo
- Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):
- Two tablets of Methyl-P Placebo
- Four tablets of CFS Nutrient Placebo
| Study group | Role | What they receive |
|---|---|---|
| Methyl-P plus Nutrient Formula | Experimental | 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. Receives: Drug: Methyl-P plus Nutrient Formula |
| Methyl-P plus Nutrient matched placebos | Placebo comparator | Methylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily. Receives: Drug: Methyl-P plus Nutrient matched placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient reported Checklist Individual Strength (CIS) Total Score
Measured: Week 12
Secondary outcomes (7)
Percentage of patients with 20% or greater improvement in the CIS total score
Measured: Week 12
Concentration Disturbances Subscore on the CIS
Measured: Week 12
Concentration Disturbances Score by Visual Analog Scale (VAS)
Measured: Week 12
Fatigue Score by Visual Analog Scale (VAS)
Measured: Week 12
Pain Symptoms by Brief Pain Inventory Form
Measured: Week 12
Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)
Measured: Week 12
Number of Participants with Adverse Events to Assess Safety and Tolerability
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue Syndrome (CFS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- K-PAX Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose Montoya, M.D., Principal investigator, Stanford University School of Medicine, Division of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966276
- Sponsor's protocol ID
- KPAX-002-01
- Status last verified
- Sep 2014
- First submitted
- 14 Oct 2013
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01966276
- Acronym / sponsor ID
- KPAX-002-01
- Keywords
- Chronic Fatigue Syndrome (CFS), Myalgic Encephalomyelitis (ME), central nervous system (CNS), fatigue, alertness, brain fog, mitochondria, methylphenidate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (actual)
- Lead sponsor
- K-PAX Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methyl-P plus Nutrient Formula | Experimental | Drug: Methyl-P plus Nutrient FormulaMethylphenidate 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. |
| Methyl-P plus Nutrient matched placebos | Placebo comparator | Drug: Methyl-P plus Nutrient matched placebosMethylphenidate matched placebo + CFS Nutrient Formula matched placebo, both taken twice daily. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methyl-P plus Nutrient FormulaAlso: Ritalin* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P (5mg) * Four tablets of CFS Nutrient Formula * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P (10mg) * Four tablets of CFS Nutrient Formula | Drug | Methyl-P plus Nutrient Formula |
| Methyl-P plus Nutrient matched placebos* Week 1 (take the following together twice a day-at breakfast and lunch) * One tablet of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo * Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch): * Two tablets of Methyl-P Placebo * Four tablets of CFS Nutrient Placebo | Drug | Methyl-P plus Nutrient matched placebos |
Primary outcome
Change in patient reported Checklist Individual Strength (CIS) Total Score
Time frame: Week 12
7 secondary outcomes
Percentage of patients with 20% or greater improvement in the CIS total score
Time frame: Week 12
Concentration Disturbances Subscore on the CIS
Time frame: Week 12
Concentration Disturbances Score by Visual Analog Scale (VAS)
Time frame: Week 12
Fatigue Score by Visual Analog Scale (VAS)
Time frame: Week 12
Pain Symptoms by Brief Pain Inventory Form
Time frame: Week 12
Patient Global Assessment of Change Questionnaires (for Fatigue and Sleep)
Time frame: Week 12
Number of Participants with Adverse Events to Assess Safety and Tolerability
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Montoya, M.D. principal investigator
Stanford University School of Medicine, Division of Infectious Diseases
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methyl-P plus Nutrient Formula in people with Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME), run by K-PAX Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported Checklist Individual Strength (CIS) Total Score (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.