EpilepsyPhase 4OAETREATeNCT03852303
Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy
A Phase 4 study testing ivermectin in people with Epilepsy, run by Universiteit Antwerpen at 1 site in Democratic Republic of the Congo.
Trial summary
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Oct 2017to 1 Jul 2019
- Phase
- Phase 4
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 5 years and above
- Signed informed consent form
- Normal neurological development until onset of epilepsy
- Onset of epilepsy between ages of 5 and 18 years
- Presence of microfilaria in skin snip and/or antibodies against Ov16
Who cannot join
- Ivermectin intake the last 9 months
- Pregnancy or breastfeeding
- Known or suspected allergy to Ivermectin
- Loa Loa microfilariae in blood
- Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with a history of cerebral malaria, meningitis or encephalitis)
- Concomitant acute illness or chronic medication use
- Chronic alcohol/substance use
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Centre de Recherche en Maladies Tropicales de l'Ituri
Rethy, Ituri
About this study
Official title: OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
Read the detailed description
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
- Conditions
- Epilepsy
- Being tested
- ivermectin
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectinDrug
Also called anti-epileptic treatment
evaluate effect of ivermectin on frequency of seizures
| Study group | Role | What they receive |
|---|---|---|
| ivermectin once a year | Active comparator | Ivermectin one dose per year and anti-epileptic treatment Receives: Drug: ivermectin |
| ivermectin 2 times a year | Experimental | Ivermectin one dose 2 times a year and anti-epileptic treatment Receives: Drug: ivermectin |
| ivermectin 3 times a year | Experimental | vermectin one dose 3 times a year and anti-epileptic treatment Receives: Drug: ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
seizure freedom
no seizures
Measured: month 9-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Oct 2017
- Primary completion31 Mar 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Principal investigator, Robert Colebunders, Universiteit Antwerpen
- Investigators
- Robert Colebunders, MD,PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852303
- Sponsor's protocol ID
- B300201733349
- Acronym
- OAETREATe
- Status last verified
- Sep 2019
- First submitted
- 21 Feb 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a
- ClinicalTrials.gov ID
- NCT03852303
- Acronym / sponsor ID
- OAETREATe / B300201733349
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 25 Feb 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.
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
Detailed description
Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| ivermectin once a year | Active comparator | Drug: ivermectinIvermectin one dose per year and anti-epileptic treatment |
| ivermectin 2 times a year | Experimental | Drug: ivermectinIvermectin one dose 2 times a year and anti-epileptic treatment |
| ivermectin 3 times a year | Experimental | Drug: ivermectinvermectin one dose 3 times a year and anti-epileptic treatment |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 5 years and above
- Signed informed consent form
- Normal neurological development until onset of epilepsy
- Onset of epilepsy between ages of 5 and 18 years
- Presence of microfilaria in skin snip and/or antibodies against Ov16
Key exclusion criteria (7 listed)
- Ivermectin intake the last 9 months
- Pregnancy or breastfeeding
- Known or suspected allergy to Ivermectin
- Loa Loa microfilariae in blood
- Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with a history of cerebral malaria, meningitis or encephalitis)
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 |
|---|---|---|
| ivermectinAlso: anti-epileptic treatmentevaluate effect of ivermectin on frequency of seizures | Drug | ivermectin 2 times a year, ivermectin 3 times a year, ivermectin once a year |
Primary outcome
seizure freedom
Time frame: month 9-12
no seizures
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 26 Sep 2019.
- Individual participant dataSharing planned: Yes. A
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Robert Colebunders, MD,PhD principal investigator
Universiteit Antwerpen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ivermectin in people with Epilepsy, run by Universiteit Antwerpen at 1 site in Democratic Republic of the Congo.
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 5 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: finished, as of the sponsor's last update on 26 Sep 2019. 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 Democratic Republic of the Congo. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
seizure freedom (time frame: month 9-12). 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 26 Sep 2019.