Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy

NCT03852303 | Completed Phase 4

• 1 other identifier: B300201733349
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• seizure freedom

  no seizures

  month 9-12

Study Arms (3)

ivermectin once a year

ACTIVE COMPARATOR

Ivermectin one dose per year and anti-epileptic treatment

Drug: ivermectin

ivermectin 2 times a year

EXPERIMENTAL

Ivermectin one dose 2 times a year and anti-epileptic treatment

Drug: ivermectin

ivermectin 3 times a year

EXPERIMENTAL

vermectin one dose 3 times a year and anti-epileptic treatment

Drug: ivermectin

Interventions

ivermectin DRUG

evaluate effect of ivermectin on frequency of seizures

Also known as: anti-epileptic treatment

ivermectin 2 times a year; ivermectin 3 times a year; ivermectin once a year

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• European Research Council: collaborator

Study Sites (1)

Centre de Recherche en Maladies Tropicales de l'Ituri

Rethy, Ituri, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Robert Colebunders, MD,PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: randomized clinical trial

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: October 1, 2017
• Primary Completion: March 31, 2019
• Study Completion: July 1, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publication of results
• Access Criteria: Approval of the PI

Locations

DE (1)