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Doxycycline for the Treatment of Nodding Syndrome

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ClinicalTrials.gov Identifier: NCT02850913
Recruitment Status : Unknown
Verified February 2017 by College of Health Sciences, Makerere University.
Recruitment status was:  Recruiting
First Posted : August 1, 2016
Last Update Posted : February 23, 2017
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
College of Health Sciences, Makerere University

Brief 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.

Condition or disease Intervention/treatment Phase
Seizures Drug: Doxycycline Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Doxycycline for the Treatment of Nodding Syndrome: A Phase II, Randomised Placebo Controlled Trial
Actual Study Start Date : September 5, 2016
Estimated Primary Completion Date : April 5, 2020
Estimated Study Completion Date : August 5, 2020


Arm Intervention/treatment
Active Comparator: Doxycycline
  • 115 participants will be randomized to oral Doxycycline 100 mg daily for six weeks.
  • Each capsule contains doxycycline hyclate equivalent to 100 mg of doxycycline base.
  • Treatment will be initiated in hospital but will be continued at home.
  • Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety.
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 Name: Doxycycline hyclate

Placebo Comparator: Placebo
  • 115 participants will be randomized to the placebo arm for matching capsules containing no active ingredients daily for six weeks.
  • Placebo will be initiated in hospital but will be continued at home.
  • Scheduled study clinic and home visits will be conducted at 6, 12, 24 months and at 2, 4 and 6 weeks respectively for adherence monitoring and assessment of safety.
Other: Placebo
- Placebo (matching capsules containing no active ingredients)




Primary Outcome Measures :
  1. Proportion of patients with antibodies to Neuron Surface Proteins (NSPs) or leiomodin at 24 months. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Mean change in serum concentrations of antibodies to NSPs or leiomodin [ Time Frame: From baseline (time 0 months) to 24 months ]
  2. Mean change in serum concentrations of C-Reactive Protein [ Time Frame: From baseline (time 0 months) to 24 months ]
  3. Mean change in serum concentrations of C3a and C3b [ Time Frame: From baseline (time 0 months) to 24 months ]
  4. Mean change in dermal microfilaria density on real time Polymerase Chain Reaction at 24 months [ Time Frame: From baseline (time 0 months) to 24 months ]
  5. The proportions of patients achieving seizure freedom (≥1 month without head nodding or convulsive seizures) [ Time Frame: 24 months ]
  6. Proportion of patients with interictal epileptiform discharges on 30-minute diagnostic EEG [ Time Frame: 24 months ]
  7. Proportion of participants with Gross Motor Function Classification System (GMFCS) scores 3-5 [ Time Frame: 24 months ]
  8. Proportion of participants with mental health disorders on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) [ Time Frame: 24 months ]
  9. Mean change in cogstate scores [ Time Frame: From baseline (time 0 months) to 24 months ]
  10. Proportion of participants with improved Quality of Life (a perception) on the Quality of Life in Childhood Epilepsy Questionnaire [ Time Frame: From baseline (time 0 months) to 24 months ]
  11. Incidence rate of non-nodding syndrome sick clinic visits and all cause sick clinic visits [ Time Frame: 24 months ]
  12. The proportion of participants with stunting (height for age Z-scores <-3 SD) [ Time Frame: 24 months ]
  13. The proportion of participants with wasting (weight for height Z-scores <-3 SD) [ Time Frame: 24 months ]
  14. All-cause mortality [ Time Frame: 24 months ]
  15. Incidence rate of all-cause hospital admissions [ Time Frame: 24 months ]


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850913


Contacts
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Contact: Richard Idro, MMED, PhD +256774274173 ridro1@gmail.com

Locations
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Uganda
Makerere University College of Health Sciences Recruiting
Kampala, Uganda, +256
Contact: Richard Idro, MMed, PhD    +256774274173    ridro1@gmail.com   
Contact: Ronald Anguzu, MBChB, MPH    +256702919292    ranguzu@musph.ac.ug   
Sponsors and Collaborators
Makerere University
University of Oxford
Investigators
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Principal Investigator: Richard Idro, MMED, PhD Makerere University College of Health Sciences
Principal Investigator: Kevin Marsh, MRCP, DTM&H University of Oxford
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: College of Health Sciences, Senior Lecturer, Makerere University
ClinicalTrials.gov Identifier: NCT02850913    
Other Study ID Numbers: 2016-022
12-16 ( Other Identifier: Oxford Tropical Research Ethics Committee (OxTREC) )
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Seizures
Nodding Syndrome
Neurologic Manifestations
Nervous System Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents