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Doxycycline for the Treatment of Nodding Syndrome

NCT02850913 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2017-02-23

No results posted yet for this study

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. 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.

Conditions

Interventions

DRUG

Doxycycline

* 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

OTHER

Placebo

\- Placebo (matching capsules containing no active ingredients)

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Richard Idro, MMED, PhD · Makerere University College of Health Sciences

  • Kevin Marsh, MRCP, DTM&H · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2020-04-05
Completion
2020-08-05

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02850913 on ClinicalTrials.gov