Chronic Fatigue SyndromePhase 1/2NCT01793415
Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
A Phase 1/2 study testing IodoCarb (r) in people with Chronic Fatigue Syndrome, run by PharmaLundensis AB at 1 site in Sweden.
Trial summary
Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- IodoCarb (r)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2013to Dec 2013
- Phase
- Phase 1/2
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic fatigue syndrome
- 35-60 years old
- Male
- Female (not pregnant or breastfeeding, using adequate highly effective contraception consistently and correctly or >1 year post-menopausal or surgically sterile).
Who cannot join
- Iodine allergy
- abnormal thyroid function or other thyroid disease such as goiter
- severely reduced kidney function (Cystatin C > 1.5 mg/L)
- alcohol/drug abuse
- severe depression
- severe fibromyalgia
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- severe cardio-vascular disease
- other severe disease, according to the clinical investigator
- participation in another ongoing clinical trial
- participation in drug trial the preceding 3 months
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Probare i Lund AB
Lund, SE-222 22
Ewa Karlsson, +46 732 300 450, ewa.karlsson@probare.se
Anders Luts, MD, PhD
About this study
Official title: Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
Read the detailed description
Chronic fatigue syndrome (CFS, which is also sometimes called ME, Myalgic Encephalomyelitis) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. They often function at a substantially lower level of activity than they were capable of before they became ill. Besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. Often, CFS can persist for many years. Researchers have not yet identified what causes CFS, and there are no specific tests to diagnose CFS. The prevalence has been suggested to be around 1-2 %.
All humans are exposed to small amounts of mercury every day from the environment. It is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. It is also known that the sensitivity to the toxic effects by mercury differs greatly between people. Thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. Therefore, the question arises if a reduction of the mercury content in the body of CFS patients can improve their symptoms and problems in daily life.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
This is a double blind placebo controlled parallel group study.
Patient population: 40 patients diagnosed with CFS will participate.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- IodoCarb (r), Placebo
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IodoCarb (r)Drug
Powder, 3 grams daily for 28+-2 days
PlaceboOther
Non-iodinated activated charcoal 3 g daily for 28+-2 days
| Study group | Role | What they receive |
|---|---|---|
| IodoCarb (r) | Active comparator | 3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days. Receives: Drug: IodoCarb (r) |
| Placebo | Placebo comparator | 3 g of non-iodinated activated charcoal daily for 28+-2 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire score
The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. Results from patients receiving active substance will be compared to patients who received placebo.
Measured: The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period.
Secondary outcomes (2)
Use of psychotropic drugs
The intake of psychotropic drugs (sedatives, anxiolytics or hypnotic drugs) during the last (fourth) treatment week is compared to the intake of psychotropic drugs during the control week just prior to the treatment period. Results from the IodoCarb group will be compared to results from the Placebo group.
Measured: The intake of psychotropic drugs during the last (fourth) treatment week is compared to the intake during the control week just prior to the treatment period.
Physical activity measured by a pedometer
The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period using a pedometer. Results from the IodoCarb group will be compared to results from the Placebo group.
Measured: The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PharmaLundensis AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Luts, MD, PhD, Principal investigator, Probare i Lund AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793415
- Sponsor's protocol ID
- PL1201
- Status last verified
- Feb 2013
- First submitted
- 7 Feb 2013
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 + 2a Proof of Concept Study of Treatment of Chronic Fatigue Syndrome (CFS) With Iodinated Activated Charcoal (IodoCarb®)
- ClinicalTrials.gov ID
- NCT01793415
- Acronym / sponsor ID
- PL1201
- Conditions
- Chronic Fatigue Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PharmaLundensis ABIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Feb 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.
Chronic fatigue syndrome (CFS) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest. Interestingly, many of the symptoms experienced by people with CFS are identical to symptoms caused by long-term low-level exposure to mercury, which is called micromercurialism.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
Detailed description
Chronic fatigue syndrome (CFS, which is also sometimes called ME, Myalgic Encephalomyelitis) is a devastating and complex disorder. People with CFS experience overwhelming fatigue and a host of other symptoms that are not improved by bed rest and that can get worse after physical activity and mental exertion. They often function at a substantially lower level of activity than they were capable of before they became ill. Besides severe fatigue, other symptoms include muscle- and joint pain, impaired memory or mental concentration, insomnia, and post-exertion malaise lasting more than 24 hours. Often, CFS can persist for many years. Researchers have not yet identified what causes CFS, and there are no specific tests to diagnose CFS. The prevalence has been suggested to be around 1-2 %.
All humans are exposed to small amounts of mercury every day from the environment. It is well-known that exposure to mercury in small quantities for a long time can affect the psychic function, and cause severe fatigue, insomnia, lack of concentration and memory problems, which is called micromercurialism. It is also known that the sensitivity to the toxic effects by mercury differs greatly between people. Thus, it is quite possible that the small amount of mercury that humans are exposed to daily are sufficient to lead to micromercurialism symptoms in sensitive individuals. Therefore, the question arises if a reduction of the mercury content in the body of CFS patients can improve their symptoms and problems in daily life.
This study will examine if the mercury binding substance IodoCarb(r) can improve the health of patients with CFS.
This is a double blind placebo controlled parallel group study.
Patient population: 40 patients diagnosed with CFS will participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IodoCarb (r) | Active comparator | Drug: IodoCarb (r)3 g iodinated activated charcoal, IodoCarb(r), daily for 28 +-2 days. |
| Placebo | Placebo comparator | Other: Placebo3 g of non-iodinated activated charcoal daily for 28+-2 days. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronic fatigue syndrome
- 35-60 years old
- Male
- Female (not pregnant or breastfeeding, using adequate highly effective contraception consistently and correctly or >1 year post-menopausal or surgically sterile).
Key exclusion criteria (10 listed)
- Iodine allergy
- abnormal thyroid function or other thyroid disease such as goiter
- severely reduced kidney function (Cystatin C > 1.5 mg/L)
- alcohol/drug abuse
- severe depression
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 |
|---|---|---|
| IodoCarb (r)Powder, 3 grams daily for 28+-2 days | Drug | IodoCarb (r) |
| PlaceboNon-iodinated activated charcoal 3 g daily for 28+-2 days | Other | Placebo |
Primary outcome
Quality of life questionnaire score
Time frame: The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period.
The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period. Results from patients receiving active substance will be compared to patients who received placebo.
2 secondary outcomes
Use of psychotropic drugs
Time frame: The intake of psychotropic drugs during the last (fourth) treatment week is compared to the intake during the control week just prior to the treatment period.
Physical activity measured by a pedometer
Time frame: The physical activity of patients during the last (fourth) treatment week is compared to the physical activity during the control week just prior to the treatment period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
- The sponsor´s web site (in swedish)Link provided by the sponsor.
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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.
Anders Luts, MD, PhD principal investigator
Probare i Lund AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IodoCarb (r) in people with Chronic Fatigue Syndrome, run by PharmaLundensis AB at 1 site in Sweden.
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 4 inclusion and 10 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 Feb 2013. 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 Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaire score (time frame: The QoL score during the last (fourth) treatment week is compared to the QoL score during the control week just prior to the treatment period.). 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 Feb 2013.