Dose-finding Study of Moxidectin for Treatment of Scabies

NCT ID: NCT03905265

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2022-02-28

Brief Summary

The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.

Conditions

Scabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Moxidectin 2 mg

Moxidectin 2 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.

Group Type: EXPERIMENTAL

Moxidectin Oral Product

Intervention Type: DRUG

The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Moxidectin 8 mg

Moxidectin 8 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.

Group Type: EXPERIMENTAL

Moxidectin Oral Product

Intervention Type: DRUG

The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Moxidectin 20 mg

Moxidectin 20 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.

Group Type: EXPERIMENTAL

Moxidectin Oral Product

Intervention Type: DRUG

The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Moxidectin 36 mg

Moxidectin 36 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind.

Group Type: EXPERIMENTAL

Moxidectin Oral Product

Intervention Type: DRUG

The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Interventions

Moxidectin Oral Product

The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged ≥ 18 years.

2. Provision of written informed consent.

3. Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the presence of at least two lesions (which may include burrows), each containing at least one live (internal and/or external structures discernable) adult Sarcoptes scabiei mite observed by reflectance confocal microscopy.

4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening and until 6 months after treatment with study product.

Exclusion Criteria

1. History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies.

2. Diagnosis of crusted/Norwegian scabies or scabies that, in the opinion of the Investigator, would require treatment with more than one standard of care (e.g. scabies requiring concurrent topical and oral treatment).

3. Received any treatment for scabies within 7 days of Screening, including but not limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion, and/or tea tree oil.

4. Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that would put the subject at increased risk from participating in the study or confound study evaluations.

5. Poor venous access.

6. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).

7. Body Mass Index over 35 kg/m2.

8. Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator.

9. Clinically relevant laboratory abnormalities at Screening, including:

1. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range;

2. creatinine > 2.0 milligrams per deciliter (mg/dL);

3. hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male);

4. amylase > 2.0 x upper limit of reference range.

10. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin.

11. Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7 out of the 14 days prior to Screening.

12. Subjects with known or suspected Loa loa coinfection.

13. Difficulty swallowing tablets.

14. Pregnant or breastfeeding, or planning to become pregnant.

15. Known or suspected alcohol or illicit substance abuse.

16. Unwilling, unlikely or unable to comply with all protocol specified assessments.

17. Previous enrolment and treatment with moxidectin in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicines Development for Global Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Darwin Hospital

Darwin, , Australia

Medizinischen Universität Wien

Vienna, , Austria

Hopital Henri Mondor AP-HP

Créteil, , France

CHU Nice Hopital Archet 2

Nice, , France

CHU Saint-Etienne Hopital Nord

Saint-Priest-en-Jarez, , France

Countries

Australia; Austria; France

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDGH-MOX-2001

Identifier Type: -

Identifier Source: org_study_id