Gulf War IllnessPhase 2NCT02357030
Methylphenidate Plus GWI-Nutrient Formula as a Treatment for Patients With Gulf War Illness
A Phase 2 study testing Methyl-P plus GWI Nutrient Formula in people with Gulf War Illness, run by K-PAX Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Methyl-P plus GWI Nutrient Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to May 2016
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Pregnancy or lactation
- Active substance or alcohol abuse and/or a history of prescription stimulant abuse
- Hospitalization within the past five years for any of the following:
- Active substance or alcohol abuse and/or a history of prescription stimulant abuse
- Major Depressive Disorder (MDD)
- Post Traumatic Stress Disorder (PTSD)
Show all 41Show fewer
- Previous or current diagnosis of schizophrenia or bipolar disorder
- Currently taking any prescription medication to treat anxiety on a daily basis
- Use of any of the below medications more than 3 times per week within the past 3 months:
- MAO inhibitors
- Anti-psychotic medications
- Prescription stimulants (i.e. Provigil®, Nuvigil®, Adderall®, Ritalin®, or any other amphetamines)
- Coumarin anticoagulants (Coumadin®)
- Daily concurrent use of more than one antidepressant medication except if one of the two antidepressant medications are one of the following (unless specifically granted a waiver by the Medical Monitor):
- Amitriptyline ≤ 100 qhs
- Trazodone ≤ 100 qhs
- Doxepin ≤ 50 qhs
- Active medical conditions including:
- Glaucoma
- Diabetes mellitus
- Current stomach or duodenal ulcer
- Uncontrolled hypertension (blood pressure at screening of systolic >160 or diastolic >90)
- Heart disease (including a history of cardiac arrhythmia, cardiac ischemia, syndrome of Torsade de Pointes, myocardial infarction or cerebrovascular event)
- Motor tics or a diagnosis or family history of Tourette's syndrome
- Previous history of seizures
- A diagnosis of any of the following conditions:
- Cancer (receiving systemic treatment either currently or within the past 12 months)
- Chronic Renal Disease
- Chronic Liver Disease
- HIV Infection
- Chronic Hepatitis B or C
- Systemic Lupus Erythematosus
- Multiple Sclerosis
- Rheumatoid Arthritis
- Parkinson's Disease
- Amyotrophic Lateral Sclerosis (ALS)
- Any chronic infectious disease lasting six months or longer
- Clinically significant laboratory test values as determined by the Medical Monitor
- Clinically significant ECG abnormalities as determined by the Medical Monitor
- The taking of another investigational treatment either currently or within 30 days of the screening visit
- 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
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Veterans Administration Palo Alto Health Care System (VAPAHCS)
Palo Alto, California, 94304
Jon D. Kaiser, M.D.
Mark Holodniy, M.D.
About this study
Official title: Phase IIa Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of KPAX 002 (Methylphenidate Hydrochloride + K-PAX Synergy) as a Treatment for Gulf War Illness in Patients Meeting the Kansas Case Definition
The Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI).
Read the detailed description
This trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a mitochondrial support nutrient formula (K-PAX Synergy) to treat Gulf War Illness (GWI).
The nutrient formula to be used in this trial is a broad-spectrum micronutrient supplement. This nutrient formula provides GWI patients with vitamins, minerals, and other cofactors (amino acids, antioxidants, and mitochondrial cofactors) to complement the low-dose Central Nervous System (CNS) stimulant (methylphenidate). The low-dose CNS stimulant provides the necessary catalyst to augment the metabolism of cellular fuel and the production of cellular energy.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 GWI symptoms and also be well tolerated without further depleting or degrading these systems.
The dose of methylphenidate (Ritalin®) 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. GWI and Chronic Fatigue Syndrome (CFS) share a high degree of symptom overlap. They have both been linked to mitochondrial dysfunction. 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 coadministered with a mitochondria support 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.
- Conditions
- Gulf War Illness
- Being tested
- Methyl-P plus GWI Nutrient Formula
- Keywords
- Gulf War Illness, nutrients, methylphenidate, mitochondria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl-P plus GWI Nutrient FormulaDrug
Also called KPAX 002
Week 1:
- One tablet of Methyl-P (5mg) twice daily
- Four tablets of GWI Nutrient Formula twice daily
Week 2 to Week 12 :
- Two tablets of Methyl-P (10mg) twice daily
- Four tablets of GWI Nutrient Formula twice daily
| Study group | Role | What they receive |
|---|---|---|
| Methyl-P plus GWI Nutrient Formula | Experimental | Methylphenidate hydrochloride plus a GWI Nutrient Formula (K-PAX Synergy), both taken twice daily. Receives: Drug: Methyl-P plus GWI Nutrient Formula |
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 (9)
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 Score by Visual Analog Scale (VAS)
Measured: Week 12
Sleep Score by Visual Analog Scale (VAS)
Measured: Week 12
Mitochondrial Function Assays
Measured: Week 12
GWI Symptoms Assessment Tool (SAT) Score
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 posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- K-PAX Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Palo Alto Health Care System
- Responsible party
- Sponsor
- Investigators
- Jon D. Kaiser, MD, Study director, K-PAX Pharmaceuticals, Inc.Mark Holodniy, MD, Principal investigator, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357030
- Sponsor's protocol ID
- K-PAX-002-2
- Other IDs
- CDMRP- GW130047
- Status last verified
- Oct 2015
- First submitted
- 25 Jan 2015
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of KPAX 002 (Methylphenidate Hydrochloride + K-PAX Synergy) as a Treatment for Gulf War Illness in Patients Meeting the Kansas Case Definition
- ClinicalTrials.gov ID
- NCT02357030
- Acronym / sponsor ID
- K-PAX-002-2
- Conditions
- Gulf War Illness
- Keywords
- Gulf War Illness, nutrients, methylphenidate, mitochondria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- K-PAX Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- VA Palo Alto Health Care System
- Study start
- Jan 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Feb 2015 (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 Gulf War Synergy Trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a GWI Nutrient Formula (K-PAX Synergy) to treat Gulf War Illness (GWI).
Detailed description
This trial will evaluate the safety and efficacy of a currently available medication, methylphenidate (Ritalin®), combined with a mitochondrial support nutrient formula (K-PAX Synergy) to treat Gulf War Illness (GWI).
The nutrient formula to be used in this trial is a broad-spectrum micronutrient supplement. This nutrient formula provides GWI patients with vitamins, minerals, and other cofactors (amino acids, antioxidants, and mitochondrial cofactors) to complement the low-dose Central Nervous System (CNS) stimulant (methylphenidate). The low-dose CNS stimulant provides the necessary catalyst to augment the metabolism of cellular fuel and the production of cellular energy.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 GWI symptoms and also be well tolerated without further depleting or degrading these systems.
The dose of methylphenidate (Ritalin®) 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. GWI and Chronic Fatigue Syndrome (CFS) share a high degree of symptom overlap. They have both been linked to mitochondrial dysfunction. 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 coadministered with a mitochondria support 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methyl-P plus GWI Nutrient Formula | Experimental | Drug: Methyl-P plus GWI Nutrient FormulaMethylphenidate hydrochloride plus a GWI Nutrient Formula (K-PAX Synergy), both taken twice daily. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (41 listed)
- Pregnancy or lactation
- Active substance or alcohol abuse and/or a history of prescription stimulant abuse
- Hospitalization within the past five years for any of the following:
- Previous or current diagnosis of schizophrenia or bipolar disorder
- 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 GWI Nutrient FormulaAlso: KPAX 002Week 1: * One tablet of Methyl-P (5mg) twice daily * Four tablets of GWI Nutrient Formula twice daily Week 2 to Week 12 : * Two tablets of Methyl-P (10mg) twice daily * Four tablets of GWI Nutrient Formula twice daily | Drug | Methyl-P plus GWI Nutrient Formula |
Primary outcome
Change in patient reported Checklist Individual Strength (CIS) total score
Time frame: Week 12
9 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 Score by Visual Analog Scale (VAS)
Time frame: Week 12
Sleep Score by Visual Analog Scale (VAS)
Time frame: Week 12
Mitochondrial Function Assays
Time frame: Week 12
GWI Symptoms Assessment Tool (SAT) Score
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 15 Oct 2015.
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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.
Jon D. Kaiser, MD study director
K-PAX Pharmaceuticals, Inc.
Mark Holodniy, MD principal investigator
VA Palo Alto Health Care System
1 site 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 GWI Nutrient Formula in people with Gulf War Illness, run by K-PAX Pharmaceuticals, Inc. at 1 site 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 0 inclusion and 41 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Contact Jessica Lopez ((650) 493-5000 ext. 62219, jessica.lopez@va.gov), or a site near the patient. 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 15 Oct 2015.