VertigoPhase 2NCT02299804
A Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo
A Phase 2 study testing Levophencynonate Hydrochloric in people with Vertigo, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
Trial summary
A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vertigo
- What is being tested?
- Levophencynonate Hydrochloric
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Aug 2015
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At the age more than 18 years old male or female;
- Patients with vertigo caused by Posterior Circulation Infarction.
- Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;
- Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);
- Ability to sign the statements of informed consent;
Who cannot join
- Female patients having Pregnant, Lactating or Birth plan recently;
- Non-posterior circulation infarction patients;
- Vertigo caused by any other diseases;
- Long-term alcohol abuse, or drug abuse;
- Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;
- History of allergies on Levophencynonate Hydrochloric or these compositions;
- Participation in another clinical trial in three months;
- Investigator thought that should be excluded due to other reason;
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: A Multicenter, Double-Blind, Phase Ⅱ Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo Caused By Posterior Circulation Infarction
A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.
Read the detailed description
This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.
- Conditions
- Vertigo
- Being tested
- Levophencynonate Hydrochloric, Placebo
- Medical subject headings
- Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levophencynonate HydrochloricDrug
this drug is M receptor inhibitor
PlaceboDrug
No active ingredient
| Study group | Role | What they receive |
|---|---|---|
| High dose arm | Experimental | Have included the Levophencynonate Hydrochloric 1.5mg bid. Receives: Drug: Levophencynonate Hydrochloric |
| Low dose arm | Experimental | Have included the Levophencynonate Hydrochloric 1.0mg bid. Receives: Drug: Levophencynonate Hydrochloric |
| Placebo arm | Placebo comparator | Have no any active component Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of vertigo
The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference.
Measured: up to 7 days
Secondary outcomes (2)
Vertigo severity improved（VAS score）
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Measured: up to 7 days
Nerve function improved（NIHSS/MRS score）
The Software Statistical Analysis System (SAS) will be used to deal with the 98 patients' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaires will be resolved by investigator.Hypothesis test results of effectiveness provide evidence as reference.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VertigoStudies 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
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yansheng Li, PHD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299804
- Sponsor's protocol ID
- LEVO-PCIV-2001
- Status last verified
- Apr 2016
- First submitted
- 9 Oct 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Phase Ⅱ Clinical Trial To Evaluate Efficacy And Safety Of Levophencynonate Hydrochloride In Patient With Vertigo Caused By Posterior Circulation Infarction
- ClinicalTrials.gov ID
- NCT02299804
- Acronym / sponsor ID
- LEVO-PCIV-2001
- Conditions
- Vertigo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Sihuan Pharmaceutical Holdings Group Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Nov 2014 (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.
A Multicenter, Double-Blind, Placebo Controlled, Phase Ⅱa clinical trial to enroll 120 patients with Vertigo Caused By Posterior Circulation Infarction during 7 days, then to evaluate the efficacy of different dose of Levophencynonate Hydrochloric, and provide the effective dosage for phase IIb clinical study, to study the safety of Levophencynonate Hydrochloric.
Detailed description
This study will conduct in 15 sites to enrolled 120 patients with vertigo under 7 days treatment and 7 days follow-up. The study includes three arms: high dose, low dose and placebo control.To observe the efficacy by change of vertigo severity and duration,and safety by vital sign,adverse event,etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose arm | Experimental | Drug: Levophencynonate HydrochloricHave included the Levophencynonate Hydrochloric 1.5mg bid. |
| Low dose arm | Experimental | Drug: Levophencynonate HydrochloricHave included the Levophencynonate Hydrochloric 1.0mg bid. |
| Placebo arm | Placebo comparator | Drug: PlaceboHave no any active component |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At the age more than 18 years old male or female;
- Patients with vertigo caused by Posterior Circulation Infarction.
- Patients diagnosed Posterior Circulation Infarction based on the criteria of Posterior Circulation Ischemia of America;
- Meet the diagnose criteria of vertigo: Visual Motion (External Vertigo), or Rotation, Swing, Lift and Tilt Sensation (Internal Vertigo);
- Ability to sign the statements of informed consent;
Key exclusion criteria (8 listed)
- Female patients having Pregnant, Lactating or Birth plan recently;
- Non-posterior circulation infarction patients;
- Vertigo caused by any other diseases;
- Long-term alcohol abuse, or drug abuse;
- Been in critical condition, difficult to make a precise evaluation of efficacy and safety of new drugs;
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 |
|---|---|---|
| Levophencynonate Hydrochloricthis drug is M receptor inhibitor | Drug | High dose arm, Low dose arm |
| PlaceboNo active ingredient | Drug | Placebo arm |
Primary outcome
The duration of vertigo
Time frame: up to 7 days
The Software Statistical Analysis System (SAS) will be used to deal with 98 subjects' data in the trial. The descriptive statistics will be presented for all efficacy and safety variables. All of questionnaire will be resolved by investigator detailed. Hypothesis test results of effectiveness provide evidence as reference.
2 secondary outcomes
Vertigo severity improved（VAS score）
Time frame: up to 7 days
Nerve function improved（NIHSS/MRS score）
Time frame: up to 7 days
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 Apr 2016.
- 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.
Yansheng Li, PHD principal investigator
RenJi Hospital
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 Levophencynonate Hydrochloric in people with Vertigo, run by Sihuan Pharmaceutical Holdings Group Ltd. at 1 site in China.
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 5 inclusion and 8 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 Apr 2016. 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 China. 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. Some participants in this study may receive a placebo. 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?
The duration of vertigo (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2016.