Chronic Fatigue SyndromeNCT01507701
Pilot Study for the NorCAPITAL Trial
A study testing Clonidine in people with Chronic Fatigue Syndrome, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Mar 2010
- Phase
- Interventional
- 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 12 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Persisting or constantly relapsing fatigue lasting 3 months or more
- Functional disability resulting from fatigue to a degree that prevent normal school attendance
- Age between 12 and 19 years
Who cannot join
- Another disease process or current demanding life event that might explain the fatigue
- Another chronic disease
- Permanent use of drugs
- Permanently bed-ridden
- Positive pregnancy test
- Supine systolic blood pressure (SBP) < 85 mm Hg
Show all 9Show fewer
- Fall in SPB upon standing > 30 mm Hg
- Supine HR < 50 beats/min
- Abnormal ECG
Trial locations and contacts
1 site in 1 country.
Norway1 site
Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
Oslo, NO-4950
About this study
The aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.
A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.
- Conditions
- Chronic Fatigue Syndrome
- Being tested
- Clonidine
- Keywords
- adolescents
- 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.
ClonidineDrug
50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Clonidine | Experimental | Not described Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration level (Cmax and Co) of clonidine
Measured: After 14 days of treatment
Secondary outcomes (3)
Orthostatic cardiovascular responses (head-up tilt test)
Measured: After 14 days of treatment
Reports of adverse effects
Measured: Participants will be followed for the duration of treatment period, an expected average of 14 days
Plasma concentration (Cmax) of clonidine
Measured: First day of treatment, approximately 5 hours after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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 N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vegard Bruun Wyller, Oslo University Hospital
- Investigators
- Vegard Bruun Wyller, MD, PhD, Principal investigator, Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507701
- Sponsor's protocol ID
- NorCAPITALps
- Status last verified
- Jan 2012
- First submitted
- 22 Dec 2011
- Last updated
- 13 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, Thaulow E, Wyller VB. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012 Aug 7;5:418. doi: 10.1186/1756-0500-5-418.
PubMed 22871021
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the NorCAPITAL Trial
- ClinicalTrials.gov ID
- NCT01507701
- Acronym / sponsor ID
- NorCAPITALps
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- First posted
- 11 Jan 2012 (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 aim of this pilot study for the NorCAPITAL trial is to investigate the feasibility and safety of the drug clonidine in adolescent chronic fatigue syndrome (CFS). Specifically, the investigators wanted to assess appropriate dosage in relation to a) plasma concentration levels of clonidine, b) orthostatic cardiovascular responses (the pulse and blood pressure responses when rising up), and c) reports of possible adverse effects.
A possible beneficial effect of clonidine in adolescent CFS will be investigated in NorCAPITAL, which is a randomized, placebo-controlled, double blind trial.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clonidine | Experimental | Drug: Clonidine |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Persisting or constantly relapsing fatigue lasting 3 months or more
- Functional disability resulting from fatigue to a degree that prevent normal school attendance
- Age between 12 and 19 years
Key exclusion criteria (9 listed)
- Another disease process or current demanding life event that might explain the fatigue
- Another chronic disease
- Permanent use of drugs
- Permanently bed-ridden
- Positive pregnancy test
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 |
|---|---|---|
| Clonidine50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation. | Drug | Clonidine |
Primary outcome
Plasma concentration level (Cmax and Co) of clonidine
Time frame: After 14 days of treatment
3 secondary outcomes
Orthostatic cardiovascular responses (head-up tilt test)
Time frame: After 14 days of treatment
Reports of adverse effects
Time frame: Participants will be followed for the duration of treatment period, an expected average of 14 days
Plasma concentration (Cmax) of clonidine
Time frame: First day of treatment, approximately 5 hours after the first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2012.
- Derived from this study: PubMed 22871021Fagermoen E, Sulheim D, Winger A, Andersen AM, Vethe NT, Saul JP, Thaulow E, Wyller VB. Clonidine in the treatment of adolescent chronic fatigue syndrome: a pilot study for the NorCAPITAL trial. BMC Res Notes. 2012 Aug 7;5:418. doi: 10.1186/1756-0500-5-418.
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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.
Vegard Bruun Wyller, MD, PhD principal investigator
Oslo University Hospital Rikshospitalet, Dept. of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clonidine in people with Chronic Fatigue Syndrome, run by Oslo University Hospital at 1 site in Norway.
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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jan 2012. 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 Norway. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Plasma concentration level (Cmax and Co) of clonidine (time frame: After 14 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01507701, which also lists 1 linked publication.
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 13 Jan 2012.