MDFS: Metoclopramide for Migraine: A Dose Finding Study

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00682734
• Collaborator: (none)
• Enrollment: 349
• Location: 1
• Arms: 3
• Duration (Months): 23
• Patients Per Site Per Month: 15.2

Study Details

Study Description

Brief Summary

Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: metoclopramide; Drug: metoclopramide; Drug: metoclopramide; Drug: Diphenhydramine 25mg	Phase 3

Detailed Description

Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Study Design

• Study Type: Interventional
• Actual Enrollment: 349 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Metoclopramide for Acute Migraine: A Dose Finding Study
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes	Drug: metoclopramide; metoclopramide 10 mg; Drug: Diphenhydramine 25mg; Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Experimental: 2 metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes.	Drug: metoclopramide; metoclopramide 20 mg; Drug: Diphenhydramine 25mg; Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Experimental: 3 metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.	Drug: metoclopramide; metoclopramide 40 mg; Drug: Diphenhydramine 25mg; Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

Outcome Measures

Primary Outcome Measures

1. Pain Intensity Score [Baseline, 60 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• acute migraine

Exclusion Criteria:

• secondary cause of headache

• lumbar puncture

• allergy or intolerance to study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Montefiore Medical Center	Bronx	New York	United States	10467

Sponsors and Collaborators

• Montefiore Medical Center

Investigators

• Principal Investigator: Benjamin W. Friedman, MD, MS, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT00682734
• Other Study ID Numbers: 07-11-405
• First Posted: May 22, 2008
• Last Update Posted: May 31, 2018
• Last Verified: May 1, 2018

• Additional relevant MeSH terms: Migraine Disorders; Diphenhydramine; Promethazine; Metoclopramide

Study Results

Participant Flow

Arm/Group Title	Metoclopramide 10 mg Intravenous	Metoclopramide 20 mg Intravenous	Metoclopramide 40 mg Intravenous
Arm/Group Description	Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous	Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
Period Title: Emergency Department Portion
STARTED	113	118	118
COMPLETED	113	117	117
NOT COMPLETED	0	1	1
Period Title: Emergency Department Portion
STARTED	113	117	117
COMPLETED	107	111	106
NOT COMPLETED	6	6	11

Baseline Characteristics

Arm/Group Title	Metoclopramide 10 mg Intravenous	Metoclopramide 20 mg	Metoclopramide 40 mg	Total
Arm/Group Description	Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous	Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous	Total of all reporting groups
Overall Participants	113	118	118	349
Age (years) [Mean (Standard Deviation) ]
Adults	38.7 (11.5)	37.5 (9.9)	38.4 (12.0)	38.2 (11.1)
Sex: Female, Male (Count of Participants)
Female	94 83.2%	103 87.3%	97 82.2%	294 84.2%
Male	19 16.8%	15 12.7%	21 17.8%	55 15.8%

Outcome Measures

1. Primary Outcome

Title	Pain Intensity Score
Description	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.
Time Frame	Baseline, 60 minutes

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Metoclopramide 10 mg Intravenous	Metoclopramide 20 mg	Metoclopramide 40 mg
Arm/Group Description	Metoclopramide 10mg intravenous + diphenhydramine 25mg intravenous	Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous	Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous
Measure Participants	113	117	117
Mean (Standard Deviation) [scores on a scale]	4.7 (2.6)	4.9 (2.8)	5.3 (2.8)

Adverse Events

Arm/Group Title	Metoclopramide 10 mg Intravenous		Metoclopramide 20 mg		Metoclopramide 40 mg
Arm/Group Description	Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous		Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous		Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous
All Cause Mortality
	Metoclopramide 10 mg Intravenous		Metoclopramide 20 mg		Metoclopramide 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Metoclopramide 10 mg Intravenous		Metoclopramide 20 mg		Metoclopramide 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/113 (0%)		1/118 (0.8%)		0/118 (0%)
Nervous system disorders
Encephalitis	0/113 (0%)	0	1/118 (0.8%)	1	0/118 (0%)	0
Other (Not Including Serious) Adverse Events
	Metoclopramide 10 mg Intravenous		Metoclopramide 20 mg		Metoclopramide 40 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/113 (7.1%)		8/118 (6.8%)		7/118 (5.9%)
Nervous system disorders
Akathisia	8/113 (7.1%)		8/118 (6.8%)		7/118 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.