Stroke, IschemicNCT03794947
Remote Ischaemic Conditioning for Fatigue After Stroke
A study testing Remote Ischaemic Conditioning in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot randomised control trial to assess the safety, compliance, and acceptability of delivering a 6-week programme of remote ischaemic conditioning (RIC) to stroke patients suffering with fatigue, and study feasibility. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Fatigue
- What is being tested?
- Remote Ischaemic Conditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Feb 2019to 14 Nov 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (aged > 18 years) who have had an ischaemic or haemorrhagic stroke at least 6 weeks prior.
- Symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28 or more).
Who cannot join
- History or presence of significant peripheral vascular disease in the upper limbs.
- History or presence of complex neuropathic pains or peripheral neuropathy in the arms.
- Presence of lymphoedema in the arms.
- Presence of skin ulceration to the arms.
- Hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks.
- Uncontrolled arrhythmia, hypertension, diabetes or angina.
Show all 13Show fewer
- Third degree heart block or progressive heart failure.
- Acute aortic dissection, myocarditis, or pericarditis.
- Acute deep vein thrombosis, pulmonary embolism or pulmonary infection.
- Suspected or known dissecting aneurysm.
- Uncontrolled visual or vestibular disturbance.
- Known or suspected cause of fatigue e.g. obstructive sleep apnoea (Epworth > 15), depression (PHQ-9 > 14).
- Modified Rankin Score > 4.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
About this study
Official title: Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial
This is a pilot randomised control trial to assess the safety, compliance, and acceptability of delivering a 6-week programme of remote ischaemic conditioning (RIC) to stroke patients suffering with fatigue, and study feasibility. A minimum of 34 patients who have suffered an ischeamic or haemorrhagic stroke and who suffer from fatigue, will be recruited and randomised to receive a 6-week programme of either RIC or a sham intervention.
Read the detailed description
Up to 75% of stroke patients suffer from fatigue, the effect of which can be physical, cognitive or emotional, and presents a large barrier to progressing rehabilitation.
Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. This may enhance the physical abilities of patients undergoing rehabilitation after stroke, particularly when aiming to improve endurance and fatigue.
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Fatigue
- Being tested
- Remote Ischaemic Conditioning, Sham Intervention
- Keywords
- remote ischaemic conditioning
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischaemic ConditioningProcedure or surgery
Induced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg).
Sham InterventionProcedure or surgery
The sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles.
| Study group | Role | What they receive |
|---|---|---|
| Remote Ischaemic Conditioning | Experimental | 4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg (arm) and 220 mmHg (leg). RIC will be completed 3 times weekly for 4 weeks. Receives: Procedure: Remote Ischaemic Conditioning |
| Sham Intervention | Sham comparator | 4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The arm and leg blood pressure cuffs in the sham intervention will inflate to 20mmHg. Sham will be completed 3 times weekly for 4 weeks. Receives: Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of Treatment-Emergent Adverse Events.
Safety of a 6-week RIC intervention will be assessed by measuring the Number of Participants With Adverse Events That Are Related to Treatment.
Measured: 6 weeks
% of RIC cycles completed
Compliance to RIC will be defined as achievement of 80% of intended RIC cycles. This will be assessed by a mobile compliance application.
Measured: 6 weeks
Number of participants reporting RIC associated discomfort on a likert scale
Reported grade of discomfort associated with RIC will be measured on a likert scale of 0-5, 0 being no discomfort 5 being great discomfort. Acceptance of RIC will be defined as less than 1/3 of participants reporting moderate or greater discomfort (3-4 on scale) and will be supported by qualitative interviews and diary recordings.
Measured: 6 weeks
number of participants recruited within the first 2 months
Study recruitment will be deemed feasible if four participants are recruited within the first 2 months.
Measured: 1 year
Percentage of assessments completed
Study assessments will be deemed feasible if >80% of assessments are completed.
Measured: 1 year
Secondary outcomes (23)
Number of participants with abnormal changes from baseline in full blood count
Number of participants with changes to full blood count between baseline and after 6 week intervention period, leading to them lying outside the 'normal' range according to Sheffield Teaching Hospitals reference ranges. Any concerns or significant abnormalities will be referred to the principle investigator for appropriate action to ensure the safety of the participant.
Measured: 6 weeks
number of participants with abnormal changes from baseline in urea and electrolyte (U&E) concentration
Number of participants with changes to U\&E concentration between baseline and after 6 week intervention period, leading to them lying outside the 'normal' range according to Sheffield Teaching Hospitals reference ranges. Any concerns or significant abnormalities will be referred to the principle investigator for appropriate action to ensure the safety of the participant.
Measured: 6 weeks
number of participants with abnormal changes from baseline in liver function
Number of participants with changes to liver function as measured by the liver function test (LFT) between baseline and after 6 week intervention period, leading to them lying outside the 'normal' range according to Sheffield Teaching Hospitals reference ranges. Any concerns or significant abnormalities will be referred to the principle investigator for appropriate action to ensure the safety of the participant.
Measured: 6 weeks
Mean change from baseline in concentration of C-reactive protein (CRP)
The inflammatory marker (CRP) will be measured at baseline and after 6 week intervention period to assess if there has been a change in concentration between baseline and after the intervention.
Measured: 6 weeks
Mean change from baseline in erythrocyte sedimentation rate (ESR)
ESR will be measured at baseline and after 6 week intervention period as a measure of inflammation.
Measured: 6 weeks
Therapy Time in minutes
Measured at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in activity Energy Expenditure measure in kCal
Energy expenditure (kCal) will be measured using ACTiheart by CamnTech throughout the intervention period and changes from the baseline reviewed at the end of the 6 week intervention.
Measured: 6 weeks
Mean change from baseline in minutes of activity per day measured by the Global Physical Activity Questionnaire (GPAQ)
The Global Physical Activity Questionnaire (GPAQ) measures physical activity levels from 3 domains: Activity at work, Travel to and from places, Recreational activities, as well as sedentary behaviour, in 16 questions, P1-P16. To analyse GPAQ data, metabolic equivalents (METs) are used to express the intensity of physical activities. MET is the ratio of a person's working relative to resting metabolic rate. Higher MET values indicate more intense activity. MET values are applied to time variables according to the intensity of the activity, 4 METS for time spent in moderate activities and 8 METS for vigorous activities. Mean/median time of physical activity on average per day is calculated by summing MET scores for all domains to calculate average activity per week, and dividing this score by 7 (p1t3+p4t6+p7t9+p10t12+p13t15)/7). The questionnaire will be completed at baseline and after 6 week intervention.
Measured: 6 weeks
Mean change from baseline in distance walked as measured by the six minute walk test (6MWT)
The six minute walk test (6 MWT) is an exercise test that entails measurement of distance walked over a span of 6 minutes. Researcher will record the total distance walked, heart rate, blood pressure and Rating of Perceived Exertion (RPE). This will be done at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in peak oxygen consumption (VO2 max, ml/Kg/min)
At baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in participant scores on the multidimensional fatigue inventory (MFI)
Measured with multidimensional fatigue inventory (MFI), a self report measure of fatigue. Participants indicate level of agreement with numerous statements associated with fatigue on a scale of 1-7, 1 being strongly disagree 7 being strongly agree. This is measured at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in participant scores on the modified rankin score (MRS)
Disability after stroke will be measured using modified rankin score (MRS), a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Symptoms are rated on a scale of 0 - 6, with 0 being 'no disability', rising in symptom severity to 6 being 'dead'. MRS will be taken at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in functional Independence as measured by the Barthel Index
Measured using Barthel Index (BI), an ordinal scale used to measure performance in 10 items (activities of daily living (ADL)). Items are rated on a scale from 0 - 15 in increments of 5, with 0 being least independent and 15 being most independent. Scores for all items are added up to give a total score out of 100, with higher scores equating to more independence. This is taken at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in depression as measured by participant scores on PHQ9
Depression will be measured using Patient Health Questionnaire (PHQ9). The patient indicates how many times over the last two weeks have they been bothered by a series of 9 issues. The scale ranges from 0/not at all to 3/ nearly every day. Scores from each item are added to produce a final score out of 27, with scores 0-4 indicating no depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-27 severe depression. This is taken at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in anxiety as measured by participant scores on the GAD7
Anxiety will be measured using the Generalised anxiety disorder assessment (GAD7). The patient indicates how many times over the last two weeks have they been bothered by a series of 7 issues. The scale ranges from 0/not at all to 3/ nearly every day. Scores from each item are added to produce a final score out of 21, Scores represent: 0-5 mild anxiety, 6-10 moderate anxiety, 11-15 moderately severe anxiety and 15-21 severe anxiety.This is taken at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in cognitive dysfunction as measured by participant scores on MOCA
Cognitive dysfunction will be measured using Montreal Cognitive Assessment (MOCA). This is a test with 8 domains, scores on each domain are added to produce a final score out of 30, with 26-30 equating to normal cognitive function. This will be completed at baseline and after 6 week intervention period.
Measured: 6 weeks
Mean change from baseline in health related quality of life as measured by participant scores on EQ5D questionnaire.
Health Related Quality of Life will be measured by the EQ5D questionnaire at baseline and after 6 week intervention. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. This can be used as a quantitative measure of health outcome that reflects the patient's own judgement. The scores on these five dimensions can be presented as a health profile or can be converted to a single summary index number (utility) reflecting preferability compared to other health profiles.
Measured: 6 weeks
Mean change from baseline in concentration of GLP-1 in blood sample
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, blood samples will be analysed for GLP-1 levels at baseline and after 6 week intervention.
Measured: 6 weeks
Mean change from baseline in heat shock protein levels
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, blood samples will be analysed for heat shock protein levels at baseline and after 6 week intervention.
Measured: 6 weeks
Changes from baseline in Cerebral Perfusion (ml/min)
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, changes in cerebral perfusion between baseline and after 6-week intervention period will be analysed.
Measured: 6 weeks
Changes from baseline in levels of N-acetyl aspartate as measured by spectroscopy
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, changes in levels of tissue metabolite N-acetyl aspartate (that may indicate loss or damage to neuronal tissue) between baseline and after 6-week intervention period will be analysed.
Measured: 6 weeks
Changes from baseline in levels of creatine as measured by spectroscopy
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, changes in levels of tissue metabolite creatine (that may indicate cell death through ischaemia) between baseline and after 6-week intervention period will be analysed.
Measured: 6 weeks
Changes from baseline in levels of lactate as measured by spectroscopy
For a subset of patients who consent to having the MRI perfusion and spectroscopy studies as well as the blood analysis of biomarkers, changes in levels of tissue metabolite lactate between baseline and after 6-week intervention period will be analysed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start4 Feb 2019
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Ali, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794947
- Sponsor's protocol ID
- STH19508
- Status last verified
- Aug 2024
- First submitted
- 29 Nov 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischaemic Conditioning for Fatigue After Stroke (RICFAST) - a Pilot, Double-blind, Randomised, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03794947
- Acronym / sponsor ID
- STH19508
- Conditions
- Stroke, Ischemic, Stroke Hemorrhagic, Fatigue
- Keywords
- remote ischaemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 7 Jan 2019 (actual)
- 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.
This is a pilot randomised control trial to assess the safety, compliance, and acceptability of delivering a 6-week programme of remote ischaemic conditioning (RIC) to stroke patients suffering with fatigue, and study feasibility. A minimum of 34 patients who have suffered an ischeamic or haemorrhagic stroke and who suffer from fatigue, will be recruited and randomised to receive a 6-week programme of either RIC or a sham intervention.
Detailed description
Up to 75% of stroke patients suffer from fatigue, the effect of which can be physical, cognitive or emotional, and presents a large barrier to progressing rehabilitation.
Remote ischaemic conditioning (RIC) is a procedure whereby ischaemia is induced to a limb for short periods of time by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). This procedure is performed for periods that avoid physical injury to the limbs, but induce neurohormonal, systemic or vascular changes in the body. Such changes often result in improved collateralisation of blood supply to various areas of the body, as well as improved efficiencies of cellular metabolism. This may enhance the physical abilities of patients undergoing rehabilitation after stroke, particularly when aiming to improve endurance and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Ischaemic Conditioning | Experimental | Procedure: Remote Ischaemic Conditioning4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg (arm) and 220 mmHg (leg). RIC will be completed 3 times weekly for 4 weeks. |
| Sham Intervention | Sham comparator | Procedure: Sham Intervention4 cycles of 5 minutes of upper or lower (depending on tolerability) limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual shygnomanometer applied to the upper arm or leg and activated to go through 4 such cycles automatically. The arm and leg blood pressure cuffs in the sham intervention will inflate to 20mmHg. Sham will be completed 3 times weekly for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (aged > 18 years) who have had an ischaemic or haemorrhagic stroke at least 6 weeks prior.
- Symptoms of debilitating fatigue for at least 4 weeks (fatigues severity score of 28 or more).
Key exclusion criteria (13 listed)
- History or presence of significant peripheral vascular disease in the upper limbs.
- History or presence of complex neuropathic pains or peripheral neuropathy in the arms.
- Presence of lymphoedema in the arms.
- Presence of skin ulceration to the arms.
- Hospitalisation for cardiovascular or cerebrovascular disease within the last 4 weeks.
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 |
|---|---|---|
| Remote Ischaemic ConditioningInduced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg). | Procedure or surgery | Remote Ischaemic Conditioning |
| Sham InterventionThe sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles. | Procedure or surgery | Sham Intervention |
Primary outcome
Number of Participants With Incidence of Treatment-Emergent Adverse Events.
Time frame: 6 weeks
Safety of a 6-week RIC intervention will be assessed by measuring the Number of Participants With Adverse Events That Are Related to Treatment.
% of RIC cycles completed
Time frame: 6 weeks
Compliance to RIC will be defined as achievement of 80% of intended RIC cycles. This will be assessed by a mobile compliance application.
Number of participants reporting RIC associated discomfort on a likert scale
Time frame: 6 weeks
Reported grade of discomfort associated with RIC will be measured on a likert scale of 0-5, 0 being no discomfort 5 being great discomfort. Acceptance of RIC will be defined as less than 1/3 of participants reporting moderate or greater discomfort (3-4 on scale) and will be supported by qualitative interviews and diary recordings.
number of participants recruited within the first 2 months
Time frame: 1 year
Study recruitment will be deemed feasible if four participants are recruited within the first 2 months.
Percentage of assessments completed
Time frame: 1 year
Study assessments will be deemed feasible if >80% of assessments are completed.
23 secondary outcomes
Number of participants with abnormal changes from baseline in full blood count
Time frame: 6 weeks
number of participants with abnormal changes from baseline in urea and electrolyte (U&E) concentration
Time frame: 6 weeks
number of participants with abnormal changes from baseline in liver function
Time frame: 6 weeks
Mean change from baseline in concentration of C-reactive protein (CRP)
Time frame: 6 weeks
Mean change from baseline in erythrocyte sedimentation rate (ESR)
Time frame: 6 weeks
Therapy Time in minutes
Time frame: 6 weeks
Mean change from baseline in activity Energy Expenditure measure in kCal
Time frame: 6 weeks
Mean change from baseline in minutes of activity per day measured by the Global Physical Activity Questionnaire (GPAQ)
Time frame: 6 weeks
Mean change from baseline in distance walked as measured by the six minute walk test (6MWT)
Time frame: 6 weeks
Mean change from baseline in peak oxygen consumption (VO2 max, ml/Kg/min)
Time frame: 6 weeks
Mean change from baseline in participant scores on the multidimensional fatigue inventory (MFI)
Time frame: 6 weeks
Mean change from baseline in participant scores on the modified rankin score (MRS)
Time frame: 6 weeks
Mean change from baseline in functional Independence as measured by the Barthel Index
Time frame: 6 weeks
Mean change from baseline in depression as measured by participant scores on PHQ9
Time frame: 6 weeks
Mean change from baseline in anxiety as measured by participant scores on the GAD7
Time frame: 6 weeks
Mean change from baseline in cognitive dysfunction as measured by participant scores on MOCA
Time frame: 6 weeks
Mean change from baseline in health related quality of life as measured by participant scores on EQ5D questionnaire.
Time frame: 6 weeks
Mean change from baseline in concentration of GLP-1 in blood sample
Time frame: 6 weeks
Mean change from baseline in heat shock protein levels
Time frame: 6 weeks
Changes from baseline in Cerebral Perfusion (ml/min)
Time frame: 6 weeks
Changes from baseline in levels of N-acetyl aspartate as measured by spectroscopy
Time frame: 6 weeks
Changes from baseline in levels of creatine as measured by spectroscopy
Time frame: 6 weeks
Changes from baseline in levels of lactate as measured by spectroscopy
Time frame: 6 weeks
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 21 Aug 2024.
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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.
Ali Ali principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Ischaemic Conditioning in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 13 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 21 Aug 2024. 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 Kingdom. 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.
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?
Number of Participants With Incidence of Treatment-Emergent Adverse Events. (time frame: 6 weeks). The study lists 5 primary outcomes in all. 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 21 Aug 2024.