drugset / Trial / NCT02850913
Doxycycline for the Treatment of Nodding Syndrome
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-09-05
- Primary completion
- 2020-04-05
- Completion
- 2020-08-05
Publications
- Idro R, Ogwang R, Anguzu R, Akun P, Ningwa A, Abbo C, Giannoccaro MP, Kubofcik J, Mwaka AD, Nakamya P, Opar B, Taylor M, Nutman TB, Elliott A, Vincent A, Newton CR, Marsh K. Doxycycline for the treatment of nodding syndrome: a randomised, placebo-controlled, phase 2 trial. Lancet Glob Health. 2024 Jul;12(7):e1149-e1158. doi: 10.1016/S2214-109X(24)00102-5. Epub 2024 May 13.
- Idro R, Anguzu R, Ogwang R, Akun P, Abbo C, Mwaka AD, Opar B, Nakamya P, Taylor M, Elliott A, Vincent A, Newton C, Marsh K. Doxycycline for the treatment of nodding syndrome (DONS); the study protocol of a phase II randomised controlled trial. BMC Neurol. 2019 Mar 6;19(1):35. doi: 10.1186/s12883-019-1256-z.
- Anguzu R, Akun PR, Ogwang R, Shour AR, Sekibira R, Ningwa A, Nakamya P, Abbo C, Mwaka AD, Opar B, Idro R. Setting up a clinical trial for a novel disease: a case study of the Doxycycline for the Treatment of Nodding Syndrome Trial - challenges, enablers and lessons learned. Glob Health Action. 2018;11(1):1431362. doi: 10.1080/16549716.2018.1431362.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Doxycycline | Small molecule | 100 mg | — |