Trial Outcomes & Findings for Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (NCT NCT00810641)

NCT ID: NCT00810641

Last Updated: 2011-06-27

Results Overview

The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 157 participants
• Primary outcome timeframe: one hour
• Results posted on: 2011-06-27

Participant Flow

Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.

We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.

Participant milestones

Measure	Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV	Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV	Sham Maneuver sham maneuver for apogeotropci HC BPPV
Overall Study STARTED	52	54	51
Overall Study COMPLETED	52	53	49
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Measure	Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV	Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV	Sham Maneuver sham maneuver for apogeotropci HC BPPV
Overall Study Withdrawal by Subject	0	1	2

Baseline Characteristics

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Baseline characteristics by cohort

Measure	Gufoni Maneuver n=52 Participants Gufoni maneuver for apogeotropic HC-BPPV	Headshaking Maneuver n=54 Participants headshaking maneuver for apogeotropic HC BPPV	Sham Maneuver n=51 Participants sham maneuver for apogeotropci HC BPPV	Total n=157 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	30 Participants n=7 Participants	27 Participants n=5 Participants	89 Participants n=4 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	67 Participants n=4 Participants
Age Continuous	57.8 years STANDARD_DEVIATION 13.5 • n=5 Participants	60.5 years STANDARD_DEVIATION 12.4 • n=7 Participants	61.5 years STANDARD_DEVIATION 14.9 • n=5 Participants	59.9 years STANDARD_DEVIATION 13.6 • n=4 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	30 Participants n=7 Participants	28 Participants n=5 Participants	97 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	60 Participants n=4 Participants
Region of Enrollment Korea, Republic of	52 participants n=5 Participants	54 participants n=7 Participants	51 participants n=5 Participants	157 participants n=4 Participants

PRIMARY outcome

Timeframe: one hour

Population: Of the 157 patients enrolled in the study, three were lost for follow-up (dropout rate, 1.9%) and 154 were finally included for analyses.

The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.

Outcome measures

Measure	Gufoni Maneuver n=52 Participants Gufoni maneuver for apogeotropic HC-BPPV	Headshaking Maneuver n=53 Participants headshaking maneuver for apogeotropic HC BPPV	Sham Maneuver n=49 Participants sham maneuver for apogeotropci HC BPPV
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial	38 participants Interval 2.48 to 13.78	33 participants Interval 1.42 to 7.17	17 participants Interval 1.78 to 9.85

Adverse Events

Gufoni Maneuver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Headshaking Maneuver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Maneuver

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Treatment of apogeotropic HC BPPV

KONOS

Phone: 82 10 5538 6565

Email: ohsun@jbnu.ac.kr

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place