OnchocerciasisPhase 2NCT00300768
Study Evaluating Orally Administered Moxidectin In Subjects With Onchocerca Volvulus Infection
A Phase 2 study testing 2 mg moxidectin, ivermectin 150 mcg/kg and 4 mg moxidectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Ghana.
Trial summary
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Onchocerciasis
- What is being tested?
- 2 mg moxidectin, ivermectin 150 mcg/kg and 4 mg moxidectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteGhana
- Study dates
- 6 Sep 2006to 29 Nov 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Written, signed (or thumb-printed), and dated informed consent
- Aged 18 to 60 years, inclusive
- Body weight ≥ 40 kg for women and ≥ 45 kg for men
- Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment.
- 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
- Adequate hematologic, renal, and hepatic function
- Skin microfilarial density within the required range for the cohort
Who cannot join
- Participation in any studies other than purely observational ones, within 4 weeks before test article administration.
- Any vaccination within 4 weeks before test article administration
- Acute infection requiring therapy within the last 10 days before test article administration
- 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
- Clinically significant ECG abnormalities or history of cardiac abnormality
- Past or current history of neurological or neuropsychiatric disease or epilepsy
Show all 17Show fewer
- Subjects with orthostatic hypotension at the screening evaluation
- History of drug or alcohol abuse or regular use of ≥ 3 cigarettes per day
- Use of alcohol or other drugs of abuse within 72 hours before test article administration
- Any condition, in the investigator's opinion, that places the subject at undue risk
- Subjects who have donated blood within 8 weeks before study entry
- 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.
- Subjects with hyperreactive onchodermatitis
- Antifilarial therapy within the previous 5 years
- Coincidental infection with Loa Loa
- Female subjects of childbearing potential with a contraindication to DMPA if not on Norplant
- Any other condition which the investigator feels would exclude the subject from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm).
Read the detailed description
This was a phase 2, randomized, ivermectin-controlled, double-blind, single-ascending-dose, parallel design, inpatient/outpatient study of moxidectin administered to subjects of both sexes with different degrees of severity of O. volvulus infection. The study was conducted at a single site in Ghana.
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.
Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg, 4 mg or 8 mg or moxidectin or ivermectin 150 µg/kg by severity of infection, based on the mean of the skin microfilariae densities at each of 4 body locations, both iliac crests and calves.
- Conditions
- Onchocerciasis
- Being tested
- 2 mg moxidectin, ivermectin 150 mcg/kg, 4 mg moxidectin, 8 mg moxidectin
- Keywords
- onchocerciasis, onchocerca volvulus, river blindness, ivermectin, moxidectin
- Medical subject headings
- Onchocerciasis, Onchocerciasis, Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 mg moxidectinDrug
Single-dose, tablet encapsulated for blinding
ivermectin 150 mcg/kgDrug
Single-dose, tablets encapsulated for blinding
4 mg moxidectinDrug
Single dose, tablets encapsulated for blinding
8 mg moxidectinDrug
single dose, tablets encapsulated for blinding
| Study group | Role | What they receive |
|---|---|---|
| 2 mg moxidectin | Experimental | 2 mg moxidectin (Dose-escalation 1st step) Receives: Drug: 2 mg moxidectin |
| Ivermectin 150 mcg/kg | Active comparator | Active comparator arm (ivermectin 150 mcg/kg). Receives: Drug: ivermectin 150 mcg/kg |
| 4 mg moxidectin | Experimental | 4 mg moxidectin (dose escalation second step) Receives: Drug: 4 mg moxidectin |
| 8 mg moxidectin | Experimental | 8 mg moxidectin (dose escalation third step) Receives: Drug: 8 mg moxidectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinical adverse events and clinically significant laboratory test results
Measured: Duration of follow up (18 months)
Secondary outcomes (3)
Skin mf counts at day 8 and months 1, 2, 3, 6, 12 and 18
Measured: day 8 and months 1, 2, 3, 6, 12, 18
Nodulectomy at 18 months
Measured: 18 months
Pharmacokinetics (PKs) at days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Measured: days 1, 2, 4, 13, and 18 and months 1, 2, 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2006 (estimated)
- Study start6 Sep 2006
- Primary completionNov 2009
- Study completion29 Nov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnchocerciasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines Development for Global Health
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization
- Responsible party
- Sponsor
- Investigators
- Nicholas Opoku, MD, Principal investigator, Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300768
- Sponsor's protocol ID
- 3110A1-200-GH
- Other IDs
- B1751004, OCRC 33
- Status last verified
- Nov 2022
- First submitted
- 7 Mar 2006
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24968000
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00300768
- Acronym / sponsor ID
- 3110A1-200-GH
- Conditions
- Onchocerciasis
- Keywords
- onchocerciasis, onchocerca volvulus, river blindness, ivermectin, moxidectin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Medicines Development for Global HealthUniversity, hospital or other
- Collaborators
- World Health Organization
- Study start
- 6 Sep 2006 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- 29 Nov 2009 (actual)
- First posted
- 9 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study was to determine the safety and tolerability of moxidectin in subjects infected with Onchocerca volvulus (a parasitic worm).
Detailed description
This was a phase 2, randomized, ivermectin-controlled, double-blind, single-ascending-dose, parallel design, inpatient/outpatient study of moxidectin administered to subjects of both sexes with different degrees of severity of O. volvulus infection. The study was conducted at a single site in Ghana.
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.
Subjects were enrolled in consecutive cohorts to receive a single oral dose of 2 mg, 4 mg or 8 mg or moxidectin or ivermectin 150 µg/kg by severity of infection, based on the mean of the skin microfilariae densities at each of 4 body locations, both iliac crests and calves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 mg moxidectin | Experimental | Drug: 2 mg moxidectin2 mg moxidectin (Dose-escalation 1st step) |
| Ivermectin 150 mcg/kg | Active comparator | Drug: ivermectin 150 mcg/kgActive comparator arm (ivermectin 150 mcg/kg). |
| 4 mg moxidectin | Experimental | Drug: 4 mg moxidectin4 mg moxidectin (dose escalation second step) |
| 8 mg moxidectin | Experimental | Drug: 8 mg moxidectin8 mg moxidectin (dose escalation third step) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written, signed (or thumb-printed), and dated informed consent
- Aged 18 to 60 years, inclusive
- Body weight ≥ 40 kg for women and ≥ 45 kg for men
- Nonpregnant, nonbreastfeeding women. Women of child bearing potential must agree to use birth control during the first 150 days after treatment.
- 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
Key exclusion criteria (17 listed)
- Participation in any studies other than purely observational ones, within 4 weeks before test article administration.
- Any vaccination within 4 weeks before test article administration
- Acute infection requiring therapy within the last 10 days before test article administration
- 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
- Clinically significant ECG abnormalities or history of cardiac abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 mg moxidectinSingle-dose, tablet encapsulated for blinding | Drug | 2 mg moxidectin |
| ivermectin 150 mcg/kgSingle-dose, tablets encapsulated for blinding | Drug | Ivermectin 150 mcg/kg |
| 4 mg moxidectinSingle dose, tablets encapsulated for blinding | Drug | 4 mg moxidectin |
| 8 mg moxidectinsingle dose, tablets encapsulated for blinding | Drug | 8 mg moxidectin |
Primary outcome
Incidence of clinical adverse events and clinically significant laboratory test results
Time frame: Duration of follow up (18 months)
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Results publication: PubMed 24968000Awadzi 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.
- Awadzi et al 2014Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Opoku, MD principal investigator
Onchocerciasis Chemotherapy Research Center, Hohoe, Ghana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 2 mg moxidectin, ivermectin 150 mcg/kg and 4 mg moxidectin in people with Onchocerciasis, run by Medicines Development for Global Health at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinical adverse events and clinically significant laboratory test results (time frame: Duration of follow up (18 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00300768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.