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Trial record 30 of 38 for:    "Elephantiasis" | "Anthelmintics"

Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00300768
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Medicines Development Limited

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 9, 2006
Last Update Posted Date November 17, 2017
Study Start Date  ICMJE September 2006
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
Incidence of clinical adverse events and clinically significant laboratory test results [ Time Frame: Duration of follow up (18 months) ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
Incidence of clinical adverse events and clinically significant laboratory test results
Change History Complete list of historical versions of study NCT00300768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
  • Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18 [ Time Frame: day 8 and months 1, 2, 3, 6, 12, 18 ]
  • Nodulectomy at 18 months [ Time Frame: 18 months ]
  • Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 [ Time Frame: days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2006)
  • Skin mf counts at day 8 and months 1, 2, 3, 6 and 12
  • Nodulectomy at 18 months
  • PK at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Official Title  ICMJE A Randomized, Single-Ascending Dose, Ivermectin-Controlled, Double-Blind, Safety, Tolerability, Pharmacokinetic, and Efficacy Study Of Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
Brief Summary

The primary purpose of this study is to determine the safety and tolerability of moxidectin in subjects infected with O. volvulus with special emphasis on Mazzotti reactions to determine whether it is safe enough to expose a number of subjects sufficient for obtaining statistically significant data on the safety and efficacy of moxidectin relative to ivermectin.

Secondary objects are to determine the pharmacokinetics of moxidectin, to obtain initial indication of the efficacy in terms of long term effect on skin microfilaria levels and an indication of the effect on the macrofilaria that may underlie the effect on skin microfilaria levels.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Onchocerciasis
Intervention  ICMJE
  • Drug: 2 mg moxidectin
    Single-dose, tablet encapsulated for blinding
  • Drug: ivermectin 150 mcg/kg
    Single-dose, tablets encapsulated for blinding
  • Drug: 4 mg moxidectin
    Single dose, tablets encapsulated for blinding
  • Drug: 8 mg moxidectin
    single dose, tablets encapsulated for blinding
Study Arms  ICMJE
  • Experimental: 2 mg moxidectin
    2 mg moxidectin (Dose-escalation 1st step)
    Intervention: Drug: 2 mg moxidectin
  • Active Comparator: Ivermectin 150 mcg/kg
    Active comparator arm (ivermectin 150 mcg/kg).
    Intervention: Drug: ivermectin 150 mcg/kg
  • Experimental: 4 mg moxidectin
    4 mg moxidectin (dose escalation second step)
    Intervention: Drug: 4 mg moxidectin
  • Experimental: 8 mg moxidectin
    8 mg moxidectin (dose escalation third step)
    Intervention: Drug: 8 mg moxidectin
Publications * Awadzi K, Opoku NO, Attah SK, Lazdins-Helds J, Kuesel AC. A randomized, single-ascending-dose, ivermectin-controlled, double-blind study of moxidectin in Onchocerca volvulus infection. PLoS Negl Trop Dis. 2014 Jun 26;8(6):e2953. doi: 10.1371/journal.pntd.0002953. eCollection 2014 Jun.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2010)
172
Original Enrollment  ICMJE
 (submitted: March 7, 2006)
192
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written, signed (or thumb-printed), and dated informed consent
  2. Aged 18 to 60 years, inclusive
  3. Body weight ≥ 40 kg for women and ≥ 45 kg for men
  4. Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment.
  5. Healthy, as determined by a physician on the basis of a physical examination, ECG, and a thorough review of the medical history and clinical laboratory results
  6. Adequate hematologic, renal, and hepatic function
  7. Skin microfilarial density within the required range for the cohort

Exclusion Criteria:

  1. Participation in any studies other than purely observational ones, within 4 weeks before test article administration.
  2. Any vaccination within 4 weeks before test article administration
  3. Acute infection requiring therapy within the last 10 days before test article administration
  4. Administration of any medication (with the exception of medication required to treat any reactions during the screening fluorescein angiography (chlorpheniramine) or paracetamol) or herbal preparation within 10 days prior to test article administration or any condition currently requiring regular medication
  5. Clinically significant ECG abnormalities or history of cardiac abnormality
  6. Past or current history of neurological or neuropsychiatric disease or epilepsy
  7. Subjects with orthostatic hypotension at the screening evaluation
  8. History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day
  9. Use of alcohol or other drugs of abuse within 72 hours before test article administration
  10. Any condition, in the investigator's opinion, that places the subject at undue risk
  11. Subjects who have donated blood within 8 weeks before study entry
  12. Subjects with ocular onchocerciasis in cohorts intended to enroll subjects with mild infection. Ocular onchocerciasis is defined by the presence of live or dead microfilariae, onchocercal punctate opacities, onchocercal lesions of the posterior segment or lesions that mimic those seen in onchocerciasis.
  13. Subjects with hyperreactive onchodermatitis
  14. Antifilarial therapy within the previous 5 years
  15. Coincidental infection with Loa Loa
  16. Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant
  17. Any other condition which the investigator feels would exclude the subject from the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ghana
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300768
Other Study ID Numbers  ICMJE OCRC-33 - 980819(B)
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicines Development Limited
Study Sponsor  ICMJE Medicines Development Limited
Collaborators  ICMJE World Health Organization
Investigators  ICMJE
Principal Investigator: Nicholas Opoku, MD Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
PRS Account Medicines Development Limited
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP