SeizuresPhase 2NCT02850913
Doxycycline for the Treatment of Nodding Syndrome
A Phase 2 study testing Doxycycline in people with Seizures, run by Makerere University at 1 site in Uganda.
Trial summary
Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children in Africa. A number of toxic, nutritional, infectious, para-infectious and environmental causes have been studied but the only consistent association has been with infection by the parasite Onchocerca volvulus. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Seizures
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUganda
- Study dates
- 5 Sep 2016to 5 Aug 2020
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants with confirmed NS as defined by the WHO i.e. Head nodding on two or more occasions (both past and current)
- Symptom onset between the ages of 3-18 years
- Observed by a trained health worker or documented on EEG
- Plus any one of:
- Triggered by food or cold weather
- Presence of other seizures or neurological abnormalities and cognitive decline
Show all 9Show fewer
- Clustering in space or time.
- Age 8 years or older
- Written consent by the parent or guardian
Who cannot join
- Females with a positive urinary HCG (pregnancy) test
- Patients receiving Phenobarbitone, Carbamazepine, Phenytoin or Rifampicin.
- Known hypersensitivity to study drug
- Withdrawal of consent since enrollment
- Reported inability to swallow capsules
- Enrolled or known agreement to enroll into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study
- Suspected high likelihood of non-compliance with study drug and the follow-up schedule - e.g. dependent on a carer who is unlikely to consistently be available.
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Makerere University College of Health Sciences
Kampala, +256
Richard Idro, MMed, PhD, +256774274173, ridro1@gmail.com
Ronald Anguzu, MBChB, MPH, +256702919292, ranguzu@musph.ac.ug
About this study
Official title: Doxycycline for the Treatment of Nodding Syndrome: A Phase II, Randomised Placebo Controlled Trial
Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children in Africa. A number of toxic, nutritional, infectious, para-infectious and environmental causes have been studied but the only consistent association has been with infection by the parasite Onchocerca volvulus. There is no specific treatment for NS and also for the adult onchocerca. However, antibiotic depletion of the Onchocerca volvulus co-symbiotic bacteria Wolbachia with tetracyclines such as doxycycline results in sterilisation and premature death of the adult worm and marked reductions in dermal microfilaria density. Potentially, such therapy that kills adult onchocerca volvulus may improve the outcome of NS if the association were true.
Read the detailed description
Primary hypothesis
Oral doxycycline 100mg daily for six weeks in patients with NS aged 8 years or older will reduce inflammatory responses and the proportion of patients with serum antibodies to NSPs or leiomodin 24 months after intervention by 40% compared to placebo.
Primary efficacy objective
To determine the effects of doxycycline 100mg daily for six weeks in patients with NS 8 years or older on serum levels of antibodies to NSPs (VGKC complex and others to be identified in a concurrent case-control study) or leiomodin at 24 months.
Study Type
This will be a two-arm, placebo-controlled (double blind) randomized phase II trial of oral doxycycline 100mg daily for six weeks.
Study site
Kitgum general hospital, Kitgum, Uganda.
Study Population
Study participants will be patients with confirmed NS as defined according to the World Health Organization (WHO) consensus case definition i.e. (i) Head nodding on two or more occasions, (ii) Occurring in clusters at a frequency of 5-20/minute, (iii) Onset between the ages of 3-18 years, (iv) Observed by a trained health worker or documented on EEG
Plus any one of:
- triggered by food or cold weather; b) presence of other seizures or neurological abnormalities and cognitive decline and c) clustering in space or time), age ≥8 years, and with written consent from a parent or guardian.
Study Interventions
Participants will receive standard of care supportive treatment according to current guidelines for NS (antiepileptic drug treatment with sodium valproate, management of psychiatric disorders, nutritional, physical and occupational therapy as indicated).
All will be hospitalised in the first weeks during which period, baseline measurements including clinical assessments, EEG, cognitive and laboratory testing will be performed and antiepileptic drug doses rationalised.
Sample size: The sample size (115 participants per arm i.e. 230 total) is estimated based on the assumption that a six-weeks treatment course of doxycycline will reduce the proportion of participants with antibodies to NSPs or Leiomodin by 40% (from 50.0% to 30.0%) 24 months after initiation of the intervention while providing for 10% loss to follow-up (β=80%, α=0.05).
Participants will then be randomised to either oral doxycycline (Azudox®, Kampala Pharmaceutical Industries, Ltd) 100mg daily for six weeks or identical placebo. Treatment will be initiated in hospital but will be continued at home. Each participant will be visited at home at 2, 4 and 6 weeks for adherence monitoring and assessment of safety and will report back to the hospital study clinic at 6, 12 and 24 months.
Follow-up procedures:
Participants will be followed up at 2, 4, and 6 weeks by the health visitor to document adherence and assess safety and will be assessed for outcomes in hospital at 24 months after initiation of the intervention.
Data Analysis:
Primary analysis will be by intention to treat. The investigators will examine the effect of doxycycline at 24 months on antibodies to host NSPs and leiomodin, inflammatory responses (CRP, C3a and C3b), on epileptiform discharges and seizure control, and microfilaria density/ Wolbachia load, and on clinical (cognitive, motor, psychiatric and quality of life) symptoms compared to placebo.
In a sub-analysis, the investigators will examine the effects of the intervention in new patients compared to patients with long standing symptoms.
- Conditions
- Seizures
- Being tested
- Doxycycline, Placebo
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxycycline hyclate
- 115 participants will be randomized to either oral Doxycycline 100 mg daily for six weeks.
- Treatment will be initiated in hospital but will be continued at home.
- Scheduled study clinic visits will be made by the participants at 6, 12 and 24 months.
- Each participant will be visited at home at 2, 4 and 6 weeks for adherence monitoring and assessment of safety
PlaceboOther
- Placebo (matching capsules containing no active ingredients)
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Active comparator | * 115 participants will be randomized to oral Doxycycline 100 mg daily for six weeks.
* Each capsule contains doxycycline hyclate equivalent to 100 mg of doxycycline base.
* Treatment will be initiated in hospital but will be continued at home.
* Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety. Receives: Drug: Doxycycline |
| Placebo | Placebo comparator | * 115 participants will be randomized to the placebo arm for matching capsules containing no active ingredients daily for six weeks.
* Placebo will be initiated in hospital but will be continued at home.
* Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with antibodies to Neuron Surface Proteins (NSPs) or leiomodin at 24 months.
Measured: 24 months
Secondary outcomes (15)
Mean change in serum concentrations of antibodies to NSPs or leiomodin
Measured: From baseline (time 0 months) to 24 months
Mean change in serum concentrations of C-Reactive Protein
Measured: From baseline (time 0 months) to 24 months
Mean change in serum concentrations of C3a and C3b
Measured: From baseline (time 0 months) to 24 months
Mean change in dermal microfilaria density on real time Polymerase Chain Reaction at 24 months
Measured: From baseline (time 0 months) to 24 months
The proportions of patients achieving seizure freedom (≥1 month without head nodding or convulsive seizures)
Measured: 24 months
Proportion of patients with interictal epileptiform discharges on 30-minute diagnostic EEG
Measured: 24 months
Proportion of participants with Gross Motor Function Classification System (GMFCS) scores 3-5
Measured: 24 months
Proportion of participants with mental health disorders on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Measured: 24 months
Mean change in cogstate scores
Measured: From baseline (time 0 months) to 24 months
Proportion of participants with improved Quality of Life (a perception) on the Quality of Life in Childhood Epilepsy Questionnaire
Measured: From baseline (time 0 months) to 24 months
Incidence rate of non-nodding syndrome sick clinic visits and all cause sick clinic visits
Measured: 24 months
The proportion of participants with stunting (height for age Z-scores <-3 SD)
Measured: 24 months
The proportion of participants with wasting (weight for height Z-scores <-3 SD)
Measured: 24 months
All-cause mortality
Measured: 24 months
Incidence rate of all-cause hospital admissions
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start5 Sep 2016
- Primary completion5 Apr 2020 (estimated)
- Study completion5 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, College of Health Sciences, Makerere University
- Investigators
- Richard Idro, MMED, PhD, Principal investigator, Makerere University College of Health SciencesKevin Marsh, MRCP, DTM&H, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02850913
- Sponsor's protocol ID
- 2016-022
- Other IDs
- 12-16
- Status last verified
- Feb 2017
- First submitted
- 9 Mar 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Idro R, Ogwang R, Anguzu R, Akun P, Ningwa A, Abbo C, Giannoccaro MP, Kubofcik J, Mwaka AD, Nakamya P, Opar B, Taylor M, Nutman TB, Elliott A, Vincent A, Newton CR, Marsh K. Doxycycline for the treatment of nodding syndrome: a randomised, placebo-controlled, phase 2 trial. Lancet Glob Health. 2024 Jul;12(7):e1149-e1158. doi: 10.1016/S2214-109X(24)00102-5. Epub 2024 May 13.
PubMed 38754459Idro R, Anguzu R, Ogwang R, Akun P, Abbo C, Mwaka AD, Opar B, Nakamya P, Taylor M, Elliott A, Vincent A, Newton C, Marsh K. Doxycycline for the treatment of nodding syndrome (DONS); the study protocol of a phase II randomised controlled trial. BMC Neurol. 2019 Mar 6;19(1):35. doi: 10.1186/s12883-019-1256-z.
PubMed 30841858Anguzu R, Akun PR, Ogwang R, Shour AR, Sekibira R, Ningwa A, Nakamya P, Abbo C, Mwaka AD, Opar B, Idro R. Setting up a clinical trial for a novel disease: a case study of the Doxycycline for the Treatment of Nodding Syndrome Trial - challenges, enablers and lessons learned. Glob Health Action. 2018;11(1):1431362. doi: 10.1080/16549716.2018.1431362.
PubMed 29382251
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doxycycline for the Treatment of Nodding Syndrome: A Phase II, Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02850913
- Acronym / sponsor ID
- 2016-022
- Conditions
- Seizures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 5 Apr 2020 (estimated)
- Study completion
- 5 Aug 2020 (estimated)
- First posted
- 1 Aug 2016 (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.
Nodding syndrome (NS) is a devastating neurologic disorder affecting thousands of children in Africa. A number of toxic, nutritional, infectious, para-infectious and environmental causes have been studied but the only consistent association has been with infection by the parasite Onchocerca volvulus. There is no specific treatment for NS and also for the adult onchocerca. However, antibiotic depletion of the Onchocerca volvulus co-symbiotic bacteria Wolbachia with tetracyclines such as doxycycline results in sterilisation and premature death of the adult worm and marked reductions in dermal microfilaria density. Potentially, such therapy that kills adult onchocerca volvulus may improve the outcome of NS if the association were true.
Detailed description
Primary hypothesis
Oral doxycycline 100mg daily for six weeks in patients with NS aged 8 years or older will reduce inflammatory responses and the proportion of patients with serum antibodies to NSPs or leiomodin 24 months after intervention by 40% compared to placebo.
Primary efficacy objective
To determine the effects of doxycycline 100mg daily for six weeks in patients with NS 8 years or older on serum levels of antibodies to NSPs (VGKC complex and others to be identified in a concurrent case-control study) or leiomodin at 24 months.
Study Type
This will be a two-arm, placebo-controlled (double blind) randomized phase II trial of oral doxycycline 100mg daily for six weeks.
Study site
Kitgum general hospital, Kitgum, Uganda.
Study Population
Study participants will be patients with confirmed NS as defined according to the World Health Organization (WHO) consensus case definition i.e. (i) Head nodding on two or more occasions, (ii) Occurring in clusters at a frequency of 5-20/minute, (iii) Onset between the ages of 3-18 years, (iv) Observed by a trained health worker or documented on EEG
Plus any one of:
- triggered by food or cold weather; b) presence of other seizures or neurological abnormalities and cognitive decline and c) clustering in space or time), age ≥8 years, and with written consent from a parent or guardian.
Study Interventions
Participants will receive standard of care supportive treatment according to current guidelines for NS (antiepileptic drug treatment with sodium valproate, management of psychiatric disorders, nutritional, physical and occupational therapy as indicated).
All will be hospitalised in the first weeks during which period, baseline measurements including clinical assessments, EEG, cognitive and laboratory testing will be performed and antiepileptic drug doses rationalised.
Sample size: The sample size (115 participants per arm i.e. 230 total) is estimated based on the assumption that a six-weeks treatment course of doxycycline will reduce the proportion of participants with antibodies to NSPs or Leiomodin by 40% (from 50.0% to 30.0%) 24 months after initiation of the intervention while providing for 10% loss to follow-up (β=80%, α=0.05).
Participants will then be randomised to either oral doxycycline (Azudox®, Kampala Pharmaceutical Industries, Ltd) 100mg daily for six weeks or identical placebo. Treatment will be initiated in hospital but will be continued at home. Each participant will be visited at home at 2, 4 and 6 weeks for adherence monitoring and assessment of safety and will report back to the hospital study clinic at 6, 12 and 24 months.
Follow-up procedures:
Participants will be followed up at 2, 4, and 6 weeks by the health visitor to document adherence and assess safety and will be assessed for outcomes in hospital at 24 months after initiation of the intervention.
Data Analysis:
Primary analysis will be by intention to treat. The investigators will examine the effect of doxycycline at 24 months on antibodies to host NSPs and leiomodin, inflammatory responses (CRP, C3a and C3b), on epileptiform discharges and seizure control, and microfilaria density/ Wolbachia load, and on clinical (cognitive, motor, psychiatric and quality of life) symptoms compared to placebo.
In a sub-analysis, the investigators will examine the effects of the intervention in new patients compared to patients with long standing symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Active comparator | Drug: Doxycycline* 115 participants will be randomized to oral Doxycycline 100 mg daily for six weeks. * Each capsule contains doxycycline hyclate equivalent to 100 mg of doxycycline base. * Treatment will be initiated in hospital but will be continued at home. * Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety. |
| Placebo | Placebo comparator | Other: Placebo* 115 participants will be randomized to the placebo arm for matching capsules containing no active ingredients daily for six weeks. * Placebo will be initiated in hospital but will be continued at home. * Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Participants with confirmed NS as defined by the WHO i.e. Head nodding on two or more occasions (both past and current)
- Age 8 years or older
- Written consent by the parent or guardian
Key exclusion criteria (7 listed)
- Females with a positive urinary HCG (pregnancy) test
- Patients receiving Phenobarbitone, Carbamazepine, Phenytoin or Rifampicin.
- Known hypersensitivity to study drug
- Withdrawal of consent since enrollment
- Reported inability to swallow capsules
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 |
|---|---|---|
| DoxycyclineAlso: Doxycycline hyclate* 115 participants will be randomized to either oral Doxycycline 100 mg daily for six weeks. * Treatment will be initiated in hospital but will be continued at home. * Scheduled study clinic visits will be made by the participants at 6, 12 and 24 months. * Each participant will be visited at home at 2, 4 and 6 weeks for adherence monitoring and assessment of safety | Drug | Doxycycline |
| Placebo- Placebo (matching capsules containing no active ingredients) | Other | Placebo |
Primary outcome
Proportion of patients with antibodies to Neuron Surface Proteins (NSPs) or leiomodin at 24 months.
Time frame: 24 months
15 secondary outcomes
Mean change in serum concentrations of antibodies to NSPs or leiomodin
Time frame: From baseline (time 0 months) to 24 months
Mean change in serum concentrations of C-Reactive Protein
Time frame: From baseline (time 0 months) to 24 months
Mean change in serum concentrations of C3a and C3b
Time frame: From baseline (time 0 months) to 24 months
Mean change in dermal microfilaria density on real time Polymerase Chain Reaction at 24 months
Time frame: From baseline (time 0 months) to 24 months
The proportions of patients achieving seizure freedom (≥1 month without head nodding or convulsive seizures)
Time frame: 24 months
Proportion of patients with interictal epileptiform discharges on 30-minute diagnostic EEG
Time frame: 24 months
Proportion of participants with Gross Motor Function Classification System (GMFCS) scores 3-5
Time frame: 24 months
Proportion of participants with mental health disorders on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Time frame: 24 months
Mean change in cogstate scores
Time frame: From baseline (time 0 months) to 24 months
Proportion of participants with improved Quality of Life (a perception) on the Quality of Life in Childhood Epilepsy Questionnaire
Time frame: From baseline (time 0 months) to 24 months
Incidence rate of non-nodding syndrome sick clinic visits and all cause sick clinic visits
Time frame: 24 months
The proportion of participants with stunting (height for age Z-scores <-3 SD)
Time frame: 24 months
The proportion of participants with wasting (weight for height Z-scores <-3 SD)
Time frame: 24 months
All-cause mortality
Time frame: 24 months
Incidence rate of all-cause hospital admissions
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Derived from this study: PubMed 38754459Idro R, Ogwang R, Anguzu R, Akun P, Ningwa A, Abbo C, Giannoccaro MP, Kubofcik J, Mwaka AD, Nakamya P, Opar B, Taylor M, Nutman TB, Elliott A, Vincent A, Newton CR, Marsh K. Doxycycline for the treatment of nodding syndrome: a randomised, placebo-controlled, phase 2 trial. Lancet Glob Health. 2024 Jul;12(7):e1149-e1158. doi: 10.1016/S2214-109X(24)00102-5. Epub 2024 May 13.
- Derived from this study: PubMed 30841858Idro R, Anguzu R, Ogwang R, Akun P, Abbo C, Mwaka AD, Opar B, Nakamya P, Taylor M, Elliott A, Vincent A, Newton C, Marsh K. Doxycycline for the treatment of nodding syndrome (DONS); the study protocol of a phase II randomised controlled trial. BMC Neurol. 2019 Mar 6;19(1):35. doi: 10.1186/s12883-019-1256-z.
- Derived from this study: PubMed 29382251Anguzu R, Akun PR, Ogwang R, Shour AR, Sekibira R, Ningwa A, Nakamya P, Abbo C, Mwaka AD, Opar B, Idro R. Setting up a clinical trial for a novel disease: a case study of the Doxycycline for the Treatment of Nodding Syndrome Trial - challenges, enablers and lessons learned. Glob Health Action. 2018;11(1):1431362. doi: 10.1080/16549716.2018.1431362.
- Individual participant dataSharing planned: No
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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.
Richard Idro, MMED, PhD principal investigator
Makerere University College of Health Sciences
Kevin Marsh, MRCP, DTM&H principal investigator
University of Oxford
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 Doxycycline in people with Seizures, run by Makerere University at 1 site in Uganda.
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 9 inclusion and 7 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 23 Feb 2017. 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 Uganda. 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 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 Richard Idro, MMED, PhD (+256774274173, ridro1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with antibodies to Neuron Surface Proteins (NSPs) or leiomodin at 24 months. (time frame: 24 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 NCT02850913, which also lists 3 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 23 Feb 2017.