Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

Epilepsy Clinical Trial

— OAETREATe  

Official title:

OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852303
• Other study ID #: B300201733349
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: September 2019
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 1, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Epilepsy
• Onchocerciasis

Intervention

Drug:
• ivermectin
evaluate effect of ivermectin on frequency of seizures

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Centre de Recherche en Maladies Tropicales de l'Ituri	Rethy	Ituri

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	European Research Council

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure freedom	no seizures	month 9-12