Sydenham ChoreaNCT00615797
Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
A study testing Intravenous immunoglobulin and standard interventions penicillin VK and haloperidol in people with Sydenham Chorea and Post Streptococcal Movement Disorder, run by University of Cape Town at 1 site in South Africa.
Trial summary
Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Sydenham Chorea, Post Streptococcal Movement Disorder
- What is being tested?
- Intravenous immunoglobulin and standard interventions penicillin VK and haloperidol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2002to Dec 2009
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Sydenham chorea moderate to severe (affecting activities of daily living) Raised ASOT titre
Who cannot join
- Mild Sydenham chorea (not affecting activities of daily living)
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Red Cross Children's Hospital
Cape Town, Western Cape, 7700
About this study
Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also "attack" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which "mop up" the antibodies may reverse or improve affected children. This study hopes to clarify this.
Read the detailed description
INTRODUCTION Acute Rheumatic Fever (ARF), chronic rheumatic heart disease (RHD) and neuropsychiatric/ movement disorders related to group A beta haemolytic streptococcal infections (GABAS) remain major public health problems in South Africa. RHD may require repeated hospital admissions, invasive surgery and often results in premature death. In Africa ARF has a mortality of 2-3%. 1 Likewise, neuropsychiatric disorders such as Sydenham's Chorea (SC) resulting from GABAS result in school difficulties, frequent absenteeism, behaviour problems such as obsessive compulsive disorder and may progress to Tourette Syndrome (personal experience). Patients may suffer from disabling neurologic and psychiatric symptoms many years after their initial episode of ARF (personal experience). The morbidity from these conditions demands enormous resources from the state in terms of medical and surgical treatment and we believe results in preventable stress and suffering to the patient and his or her family. Whilst the ideal goal is primary prevention a measure of secondary prevention has been attained by the use of monthly prophylactic penilente. In cases where ARF has occurred, some further intervention is desirable, to prevent the above complications.
At the Rheumatic Fever Clinic (RFC) at Red Cross Hospital patients with established RHD and old cases of Sydenham's Chorea ( SC) are seen. There are 2-4 new cases of ARF seen per month. ARF remains a notifiable disease but it appears that these new cases are often not notified. (personal communication PAWC health officials) SC is a major manifestation of ARF and following the 1992 update of the modified Jones Criteria, it is sufficient alone to make a diagnosis of ARF.2 The duration of SC ranges from a few weeks to 2 years. Recurrences occur in one third of patients.3 Current treatment of SC is purely symptomatic and whether it resolves in 6 weeks or 2 years is dependent on innate healing mechanisms within the individual. SC is postulated to be mediated through auto- antibodies that mis-recognise neuronal cell components. These complexes then result in an inflammatory response in the basal ganglia with the resultant clinical picture of SC. 3 We hypothesise, that the use of intravenous immunoglobulins ( IVIG) will decrease the number of circulating antibodies thereby decreasing symptom severity and shortening the course of the illness. Prophylactic penicillin must be continued to prevent re-exposure and further formation of antibodies.
AIM We aim to determine whether treatment of SC with IVIG expedites recovery and thus cuts down on morbidity and frequent follow up.
METHOD Our aim is to collect a minimum of 20 patients with acute SC, diagnosed according to the revised Jones Criteria for ARF and with an absence of indicators of other causes of chorea. (Table 1) The study would run for 4 years or until the minimum number are recruited.
Patients would be identified and the chorea would be rated as mild, moderate or severe and all signs of chorea carefully documented as per attached format. (A) Special investigations would be performed (Table 2). Patients with IgA deficiency would be excluded from the study. Informed consent would be obtained. Patients would be randomly selected to receive IVIG and or standard treatment. Each patient will be allocated a code number.
Patients will be admitted to a neurology bed, as usually occurs for the acute management of moderate and severe SC. Patients will be notified.
Standard pharmacological treatment (Table 3) of haloperidol and or sodium valproate will be administered, in addition the trial group will receive IVIG. All patients will commence penicillin prophylaxis. On day two (once the administration of IVIG is complete) the investigator (KW) and a blinded observer (WM) will examine the patient for signs of chorea as per addendum A.
The patient will remain hospitalised until he or she can cope with activities of daily living.
Patients will be reviewed at one month, 3 months, 6 months and 1 year and any other time if necessary, this being consistent with current management. They will be assessed by a blinded observer (WM) and by the chief investigator(KW). Follow up will be at the RFC.
IMI penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG NB. Improvement of symptoms with IVIG alone, can only be expected after the third week post treatment.5 The aim of this therapy is to shorten the overall course of the illness and to prevent complications.
SAMPLE SIZE We aim to get a minimum of twenty cases, 10 will receive IVIG and 10 standard treatment.
ANALYSIS Aim to get a minimum of 20 new cases. Statistical analysis of the outcome measures will be undertaken.
ETHICS / CONSENT In recent years IVIG have been used successfully and safely in a number of auto-immune conditions. 4 Informed consent will be obtained. Parent consent forms will be available in English, Afrikaans and Xhosa COSTING Salaries. No contract staff or casual assistants would be employed. Already salaried staff would look after the patients. Patients with SC are usually admitted to hospital and all the above treatment is administered except for the administration of IVIG, the assessment of serum gamma-globulins and brain spectroscopy scans (single photon emission computed tomographic scanning). The department of Nuclear Medicine has consented to perform these scans. It has been shown that in hemichorea hypermetabolism occurs in the contralateral basal ganglion and this disappears with resolution of symptoms.8 Nursing duties would remain the same as for current admissions of SC. The only additional nursing duty would be the monitoring of the IV infusion.
The registrars and senior house officers will assist in the management of these patients. As stated earlier ARF is a public health problem in South Africa. It is important therefore that health professionals are aware of the preventative and curative treatments available for the treatment of SC.
ADDENDUM A
ACUTE SYDENHAM'S CHOREA
Patient Details
Present History
Past history
Family and Social History
General examination
Details of CVS
Details of Chorea
To be graded as severe, moderate and mild Severe: unable to ambulate or perform any activity of daily living (ADL) Moderate: ambulate with assistance and able to perform some ADLs Mild: ambulate unaided and able to perform most ADLs Minimal: chorea elicited only during neurological examination (9)
Document whether Hemi-chorea or bilateral
Day 0 = Day of admission Day 1 = treatment commenced
Signs of Chorea Day 0 Day 5 1 mth 3 mth 6 mth 1 year Hypotonia Hungup knee jerks Milkmaid's Grip Darting Tongue Pronator Sign Dishing Spoon hand Hippus Weakness Emotional lability Behaviour disturbances Explosive or indistinct speech Facial Grimaces Generalised restlessness Inappropriate Behaviour eg OCD Shrugging shoulders Writhing TOTAL
(10) Definition of Signs Milkmaid's Grip : inability to maintain contraction when the patient grasps the examiners fingers Darting Tongue: inability to maintain protrusion of the tongue Pronator Sign: tendency to pronate one or both hands when they are extended overhead Dishing Spoon Hand: assumption of a hand posture consisting of wrist flexion, hyperextension of the metacarpophalangeal joints, finger straightening and thumb abduction Hippus: reflex constriction and dilation of pupil Hung up knee jerks: slow to return to pre test position
MEDICATION CHART
Date Medication Dose Side Effects Comments
PATIENT'S STICKER
- Being tested
- Intravenous immunoglobulin, standard interventions penicillin VK and haloperidol
- Medical subject headings
- Chorea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous immunoglobulinBiological
intravenous immunoglobulin 2g/kg total given over 2 days
standard interventions penicillin VK and haloperidolDrug
Penicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea Receives: Biological: Intravenous immunoglobulin |
| 2 | Placebo comparator | Group randomized to receive standard intervention for sydenham's chorea alone Receives: Drug: standard interventions penicillin VK and haloperidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved scores on the sydenham chorea assessment charts
Measured: 6 months
Secondary outcomes (1)
improved quality of life
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startMay 2002
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Sydenham ChoreaStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Natal Bioproducts Institute
- Responsible party
- Principal investigator, Jo M Wilmshurst, University of Cape Town
- Investigators
- Kathleen Walker, MB ChB, Principal investigator, Red Cross Children's Hospital, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615797
- Sponsor's protocol ID
- CTXO1-2002
- Other IDs
- REF049/2002
- Status last verified
- Dec 2014
- First submitted
- 1 Feb 2008
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8. doi: 10.1016/S0140-6736(98)12297-3.
PubMed 10513708Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.
PubMed 7661914Barron KS, Sher MR, Silverman ED. Intravenous immunoglobulin therapy: magic or black magic. J Rheumatol Suppl. 1992 Apr;33:94-7.
PubMed 1593608Gregorowski C, Lochner C, Martin L, Simmons C, Kidd M, Walker K, Wilmshurst JM, Seedat S. Neuropsychological manifestations in children with Sydenham's chorea after adjunct intravenous immunoglobulin and standard treatment. Metab Brain Dis. 2016 Feb;31(1):205-12. doi: 10.1007/s11011-015-9681-1. Epub 2015 May 19.
PubMed 25987537Walker K, Brink A, Lawrenson J, Mathiassen W, Wilmshurst JM. Treatment of sydenham chorea with intravenous immunoglobulin. J Child Neurol. 2012 Feb;27(2):147-55. doi: 10.1177/0883073811414058. Epub 2011 Aug 24.
PubMed 21868369
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Immunoglobulins as Effective Treatment in Sydenham's Chorea
- ClinicalTrials.gov ID
- NCT00615797
- Acronym / sponsor ID
- CTXO1-2002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Natal Bioproducts Institute
- Study start
- May 2002
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Feb 2008 (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.
Children are at risk of developing an involuntary movement disorder after streptococcal throat infections. Not all children are affected and the severity is individually variable. Affected children have alteration in their behaviour and mood and can become quite compromised in their activities of daily living. The condition is believed to be related to the body having an over efficient immune response to the infection and some of the antibodies made in response to the infection also "attack" centres in the brain controlling movement and mood. Treating these children with immunoglobulins, which "mop up" the antibodies may reverse or improve affected children. This study hopes to clarify this.
Detailed description
INTRODUCTION Acute Rheumatic Fever (ARF), chronic rheumatic heart disease (RHD) and neuropsychiatric/ movement disorders related to group A beta haemolytic streptococcal infections (GABAS) remain major public health problems in South Africa. RHD may require repeated hospital admissions, invasive surgery and often results in premature death. In Africa ARF has a mortality of 2-3%. 1 Likewise, neuropsychiatric disorders such as Sydenham's Chorea (SC) resulting from GABAS result in school difficulties, frequent absenteeism, behaviour problems such as obsessive compulsive disorder and may progress to Tourette Syndrome (personal experience). Patients may suffer from disabling neurologic and psychiatric symptoms many years after their initial episode of ARF (personal experience). The morbidity from these conditions demands enormous resources from the state in terms of medical and surgical treatment and we believe results in preventable stress and suffering to the patient and his or her family. Whilst the ideal goal is primary prevention a measure of secondary prevention has been attained by the use of monthly prophylactic penilente. In cases where ARF has occurred, some further intervention is desirable, to prevent the above complications.
At the Rheumatic Fever Clinic (RFC) at Red Cross Hospital patients with established RHD and old cases of Sydenham's Chorea ( SC) are seen. There are 2-4 new cases of ARF seen per month. ARF remains a notifiable disease but it appears that these new cases are often not notified. (personal communication PAWC health officials) SC is a major manifestation of ARF and following the 1992 update of the modified Jones Criteria, it is sufficient alone to make a diagnosis of ARF.2 The duration of SC ranges from a few weeks to 2 years. Recurrences occur in one third of patients.3 Current treatment of SC is purely symptomatic and whether it resolves in 6 weeks or 2 years is dependent on innate healing mechanisms within the individual. SC is postulated to be mediated through auto- antibodies that mis-recognise neuronal cell components. These complexes then result in an inflammatory response in the basal ganglia with the resultant clinical picture of SC. 3 We hypothesise, that the use of intravenous immunoglobulins ( IVIG) will decrease the number of circulating antibodies thereby decreasing symptom severity and shortening the course of the illness. Prophylactic penicillin must be continued to prevent re-exposure and further formation of antibodies.
AIM We aim to determine whether treatment of SC with IVIG expedites recovery and thus cuts down on morbidity and frequent follow up.
METHOD Our aim is to collect a minimum of 20 patients with acute SC, diagnosed according to the revised Jones Criteria for ARF and with an absence of indicators of other causes of chorea. (Table 1) The study would run for 4 years or until the minimum number are recruited.
Patients would be identified and the chorea would be rated as mild, moderate or severe and all signs of chorea carefully documented as per attached format. (A) Special investigations would be performed (Table 2). Patients with IgA deficiency would be excluded from the study. Informed consent would be obtained. Patients would be randomly selected to receive IVIG and or standard treatment. Each patient will be allocated a code number.
Patients will be admitted to a neurology bed, as usually occurs for the acute management of moderate and severe SC. Patients will be notified.
Standard pharmacological treatment (Table 3) of haloperidol and or sodium valproate will be administered, in addition the trial group will receive IVIG. All patients will commence penicillin prophylaxis. On day two (once the administration of IVIG is complete) the investigator (KW) and a blinded observer (WM) will examine the patient for signs of chorea as per addendum A.
The patient will remain hospitalised until he or she can cope with activities of daily living.
Patients will be reviewed at one month, 3 months, 6 months and 1 year and any other time if necessary, this being consistent with current management. They will be assessed by a blinded observer (WM) and by the chief investigator(KW). Follow up will be at the RFC.
IMI penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG NB. Improvement of symptoms with IVIG alone, can only be expected after the third week post treatment.5 The aim of this therapy is to shorten the overall course of the illness and to prevent complications.
SAMPLE SIZE We aim to get a minimum of twenty cases, 10 will receive IVIG and 10 standard treatment.
ANALYSIS Aim to get a minimum of 20 new cases. Statistical analysis of the outcome measures will be undertaken.
ETHICS / CONSENT In recent years IVIG have been used successfully and safely in a number of auto-immune conditions. 4 Informed consent will be obtained. Parent consent forms will be available in English, Afrikaans and Xhosa COSTING Salaries. No contract staff or casual assistants would be employed. Already salaried staff would look after the patients. Patients with SC are usually admitted to hospital and all the above treatment is administered except for the administration of IVIG, the assessment of serum gamma-globulins and brain spectroscopy scans (single photon emission computed tomographic scanning). The department of Nuclear Medicine has consented to perform these scans. It has been shown that in hemichorea hypermetabolism occurs in the contralateral basal ganglion and this disappears with resolution of symptoms.8 Nursing duties would remain the same as for current admissions of SC. The only additional nursing duty would be the monitoring of the IV infusion.
The registrars and senior house officers will assist in the management of these patients. As stated earlier ARF is a public health problem in South Africa. It is important therefore that health professionals are aware of the preventative and curative treatments available for the treatment of SC.
ADDENDUM A
ACUTE SYDENHAM'S CHOREA
Patient Details
Present History
Past history
Family and Social History
General examination
Details of CVS
Details of Chorea
To be graded as severe, moderate and mild Severe: unable to ambulate or perform any activity of daily living (ADL) Moderate: ambulate with assistance and able to perform some ADLs Mild: ambulate unaided and able to perform most ADLs Minimal: chorea elicited only during neurological examination (9)
Document whether Hemi-chorea or bilateral
Day 0 = Day of admission Day 1 = treatment commenced
Signs of Chorea Day 0 Day 5 1 mth 3 mth 6 mth 1 year Hypotonia Hungup knee jerks Milkmaid's Grip Darting Tongue Pronator Sign Dishing Spoon hand Hippus Weakness Emotional lability Behaviour disturbances Explosive or indistinct speech Facial Grimaces Generalised restlessness Inappropriate Behaviour eg OCD Shrugging shoulders Writhing TOTAL
(10) Definition of Signs Milkmaid's Grip : inability to maintain contraction when the patient grasps the examiners fingers Darting Tongue: inability to maintain protrusion of the tongue Pronator Sign: tendency to pronate one or both hands when they are extended overhead Dishing Spoon Hand: assumption of a hand posture consisting of wrist flexion, hyperextension of the metacarpophalangeal joints, finger straightening and thumb abduction Hippus: reflex constriction and dilation of pupil Hung up knee jerks: slow to return to pre test position
MEDICATION CHART
Date Medication Dose Side Effects Comments
PATIENT'S STICKER
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Intravenous immunoglobulinGroup randomized to receive intravenous immunoglobulins in addition to standard therapy for sydenham's chorea |
| 2 | Placebo comparator | Drug: standard interventions penicillin VK and haloperidolGroup randomized to receive standard intervention for sydenham's chorea alone |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Sydenham chorea moderate to severe (affecting activities of daily living) Raised ASOT titre
Key exclusion criteria (1 listed)
- Mild Sydenham chorea (not affecting activities of daily living)
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 |
|---|---|---|
| Intravenous immunoglobulinintravenous immunoglobulin 2g/kg total given over 2 days | Biological | 1 |
| standard interventions penicillin VK and haloperidolPenicillin V K 500mg 12hrly po or 250mg 6 hrly for 10 days IM penicillin to be given at discharge, 1.2 million units if over 30 KG and 600,000 units if weight less than 30 KG haloperidol 0,025mg/kg/day orally in divided doses gradually increasing to a maximum of 0,05mg/kg/day | Drug | 2 |
Primary outcome
improved scores on the sydenham chorea assessment charts
Time frame: 6 months
1 secondary outcome
improved quality of life
Time frame: 2 years
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 4 Dec 2014.
- Background: PubMed 10513708Perlmutter SJ, Leitman SF, Garvey MA, Hamburger S, Feldman E, Leonard HL, Swedo SE. Therapeutic plasma exchange and intravenous immunoglobulin for obsessive-compulsive disorder and tic disorders in childhood. Lancet. 1999 Oct 2;354(9185):1153-8. doi: 10.1016/S0140-6736(98)12297-3.
- Background: PubMed 7661914Swedo SE. Sydenham's chorea. A model for childhood autoimmune neuropsychiatric disorders. JAMA. 1994 Dec 14;272(22):1788-91. doi: 10.1001/jama.272.22.1788. No abstract available.
- Background: PubMed 1593608Barron KS, Sher MR, Silverman ED. Intravenous immunoglobulin therapy: magic or black magic. J Rheumatol Suppl. 1992 Apr;33:94-7.
- Derived from this study: PubMed 25987537Gregorowski C, Lochner C, Martin L, Simmons C, Kidd M, Walker K, Wilmshurst JM, Seedat S. Neuropsychological manifestations in children with Sydenham's chorea after adjunct intravenous immunoglobulin and standard treatment. Metab Brain Dis. 2016 Feb;31(1):205-12. doi: 10.1007/s11011-015-9681-1. Epub 2015 May 19.
- Derived from this study: PubMed 21868369Walker K, Brink A, Lawrenson J, Mathiassen W, Wilmshurst JM. Treatment of sydenham chorea with intravenous immunoglobulin. J Child Neurol. 2012 Feb;27(2):147-55. doi: 10.1177/0883073811414058. Epub 2011 Aug 24.
Related trials for Sydenham Chorea
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TREAT-SC: Early, Short Course Oral Dexamethasone for the Treatment of Sydenham Chorea in Children
Rheumatic Fever, Sydenham Chorea
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.
Kathleen Walker, MB ChB principal investigator
Red Cross Children's Hospital, University of Cape Town
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous immunoglobulin and standard interventions penicillin VK and haloperidol in people with Sydenham Chorea and Post Streptococcal Movement Disorder, run by University of Cape Town at 1 site in South Africa.
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 1 inclusion and 1 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 4 Dec 2014. 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 South Africa. 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?
improved scores on the sydenham chorea assessment charts (time frame: 6 months). 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 NCT00615797, which also lists 5 linked publications.
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 4 Dec 2014.