Trial Outcomes & Findings for Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (NCT NCT02046980)

NCT ID: NCT02046980

Last Updated: 2016-03-11

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 209 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2016-03-11

Participant Flow

217 patients enrolled in the study but 8 retracted their agreements.

Participant milestones

Measure	Gufoni Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day Gufoni	Vibration Vibration maneuver for apogeotropic horizontal BPPV at the first day Vibration	Sham Sham maneuver for apogeotropic horizontal BPPV at the first day Sham
Overall Study STARTED	72	72	73
Overall Study COMPLETED	70	67	72
Overall Study NOT COMPLETED	2	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

Baseline characteristics by cohort

Measure	Gufoni n=70 Participants Gufoni maneuver for apogeotropic horizontal BPPV at the first day Gufoni	Vibration n=67 Participants Vibration maneuver for apogeotropic horizontal BPPV at the first day Vibration	Sham n=72 Participants Sham maneuver for apogeotropic horizontal BPPV at the first day Sham	Total n=209 Participants Total of all reporting groups
Lesion side Left side	29 participants n=5 Participants	30 participants n=7 Participants	39 participants n=5 Participants	98 participants n=4 Participants
Age, Continuous	62.00 years STANDARD_DEVIATION 11.58 • n=5 Participants	62.22 years STANDARD_DEVIATION 13.25 • n=7 Participants	61.44 years STANDARD_DEVIATION 13.48 • n=5 Participants	61.9 years STANDARD_DEVIATION 12.7 • n=4 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	39 Participants n=7 Participants	52 Participants n=5 Participants	133 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	20 Participants n=5 Participants	76 Participants n=4 Participants
Symptom duration	3.37 days n=5 Participants	2.70 days n=7 Participants	2.52 days n=5 Participants	2.9 days n=4 Participants
Lesion side Right side	41 participants n=5 Participants	37 participants n=7 Participants	33 participants n=5 Participants	111 participants n=4 Participants

PRIMARY outcome

Timeframe: 2 days

Population: 217 patients enrolled in the study but 8 retracted their agreements.

Outcome measures

Measure	Gufoni n=70 Participants Gufoni maneuver for apogeotropic horizontal BPPV at the first day Gufoni	Vibration n=67 Participants Vibration maneuver for apogeotropic horizontal BPPV at the first day Vibration	Sham n=72 Participants Sham maneuver for apogeotropic horizontal BPPV at the first day Sham
Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus	51 participants	46 participants	38 participants

Adverse Events

Gufoni

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vibration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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

Dr. Hyun Ah Kim

Daegu Kyungbook Dizziness society

Phone: +82-53-250-7475

Email: kha0206@dsmc.or.kr

Results disclosure agreements

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