Trial Outcomes & Findings for Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice (NCT NCT01759251)

Results Overview

Number of patients with clinical response on treatment determined with SVVSLCRE

Recruitment status

COMPLETED

Target enrollment

309 participants

Primary outcome timeframe

Up to 2 months

Results posted on

2015-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	Vestibular Vertigo Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
30 Days Treatment Period STARTED	309
30 Days Treatment Period COMPLETED	305
30 Days Treatment Period NOT COMPLETED	4
60 Days Treatment Period STARTED	305
60 Days Treatment Period COMPLETED	305
60 Days Treatment Period NOT COMPLETED	0
Follow-up Period STARTED	305
Follow-up Period COMPLETED	305
Follow-up Period NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Betaserc® (Betahistine Dihydrochloride) in Patients With Vestibular Vertigo in Routine Practice

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vestibular Vertigo n=309 Participants Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
Age, Continuous	53.5 years STANDARD_DEVIATION 15.1 • n=5 Participants
Sex: Female, Male Female	220 Participants n=5 Participants
Sex: Female, Male Male	89 Participants n=5 Participants
Region of Enrollment Ukraine	102 participants n=5 Participants
Region of Enrollment Russian Federation	207 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 months

Population: 60 days treatment group

Number of patients with clinical response on treatment determined with SVVSLCRE

Outcome measures

Outcome measures
Measure	Vestibular Vertigo n=305 Participants Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) excellent	43 participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) very good	79 participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) good	104 participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) moderate	61 participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) no change	15 participants
Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE) worsening	3 participants

SECONDARY outcome

Timeframe: From Day 0 to 2 months

determined with the Scale for Vestibular Vertigo Severity Level and Clinical Response Evaluation (SVVSLCRE)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From Day 0 to 2 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From 2 months to 4 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 months

determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 months

determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 months

vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 2 months

vertigo associated symptoms: tinnitus, hearing loss, nausea, vomiting, faintness and headache; determined with a four-point-scale, where 4 = excellent, 3 = good, 2 = fair, and 1 = poor.

Outcome measures

Outcome data not reported

Adverse Events

Vestibular Vertigo

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

Associate Director Clinical Services

Abbott

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator shall not publish /present the results without Abbott's prior written consent. In the event that applicable law permits Investigator to publish or present results without Abbott's prior written consent, Investigator shall provide Abbott with a complete copy of such publication or presentation at least 60 days prior to submission for publication or presentation and Investigator shall reasonably consider all comments which Abbott may provide regarding such publication or presentation.
Publication restrictions are in place

Restriction type: OTHER