Doxycycline for the Treatment of Nodding Syndrome

• Status: Unknown status
• Trial end date: 2020-08-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborator: University of Oxford
• Treatments: Doxycycline

Criteria

Inclusion Criteria:

1. 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

• Clustering in space or time.

2. Age 8 years or older

3. Written consent by the parent or guardian

Exclusion Criteria:

1. Females with a positive urinary HCG (pregnancy) test

2. Patients receiving Phenobarbitone, Carbamazepine, Phenytoin or Rifampicin.

3. Known hypersensitivity to study drug

4. Withdrawal of consent since enrollment

5. Reported inability to swallow capsules

6. Enrolled or known agreement to enroll into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study

7. 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.