Trial Outcomes & Findings for Metoclopramide for Migraine: A Dose Finding Study (NCT NCT00682734)

NCT ID: NCT00682734

Last Updated: 2018-05-31

Results Overview

Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 349 participants
• Primary outcome timeframe: Baseline, 60 minutes
• Results posted on: 2018-05-31

Participant Flow

Participant milestones

Measure	Metoclopramide 10 mg Intravenous Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous	Metoclopramide 20 mg Intravenous Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg Intravenous Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
Emergency Department Portion STARTED	113	118	118
Emergency Department Portion COMPLETED	113	117	117
Emergency Department Portion NOT COMPLETED	0	1	1
48 Hour Follow-up STARTED	113	117	117
48 Hour Follow-up COMPLETED	107	111	106
48 Hour Follow-up NOT COMPLETED	6	6	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Metoclopramide for Migraine: A Dose Finding Study

Baseline characteristics by cohort

Measure	Metoclopramide 10 mg Intravenous n=113 Participants Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous	Metoclopramide 20 mg n=118 Participants Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg n=118 Participants Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous	Total n=349 Participants Total of all reporting groups
Age, Continuous Adults	38.7 years STANDARD_DEVIATION 11.5 • n=5 Participants	37.5 years STANDARD_DEVIATION 9.9 • n=7 Participants	38.4 years STANDARD_DEVIATION 12.0 • n=5 Participants	38.2 years STANDARD_DEVIATION 11.1 • n=4 Participants
Sex: Female, Male Female	94 Participants n=5 Participants	103 Participants n=7 Participants	97 Participants n=5 Participants	294 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	21 Participants n=5 Participants	55 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 60 minutes

Population: per protocol

Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.

Outcome measures

Measure	Metoclopramide 10 mg Intravenous n=113 Participants Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous	Metoclopramide 20 mg n=117 Participants Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg n=117 Participants Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
Pain Intensity Score	4.7 scores on a scale Standard Deviation 2.6	4.9 scores on a scale Standard Deviation 2.8	5.3 scores on a scale Standard Deviation 2.8

Adverse Events

Metoclopramide 10 mg Intravenous

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Metoclopramide 20 mg

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Metoclopramide 40 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metoclopramide 10 mg Intravenous n=113 participants at risk Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous	Metoclopramide 20 mg n=118 participants at risk Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg n=118 participants at risk Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
Nervous system disorders Encephalitis	0.00% 0/113	0.85% 1/118 • Number of events 1	0.00% 0/118

Other adverse events

Measure	Metoclopramide 10 mg Intravenous n=113 participants at risk Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous	Metoclopramide 20 mg n=118 participants at risk Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg n=118 participants at risk Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
Nervous system disorders Akathisia	7.1% 8/113	6.8% 8/118	5.9% 7/118

Additional Information

Benjamin Friedman

Montefiore Medical Center

Phone: 718 920 6626

Email: befriedm@montefiore.org

Results disclosure agreements

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