NCT01080677

Brief Summary

This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
7 years until next milestone

Results Posted

Study results publicly available

February 24, 2017

Completed
Last Updated

February 24, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

March 2, 2010

Results QC Date

January 28, 2015

Last Update Submit

January 4, 2017

Conditions

Migraine Disorders

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Reporting Pain Relief at 2 Hrs Post First Administration of Caffeine/Propranolol (Defined as a Decrease in Headache Pain Intensity From Severe or Moderate Headache Pain at Baseline to Mild or no Pain at 2 Hrs)

    2 hours

Secondary Outcomes (3)

  • Percentage of Participants Pain Free at 2 Hrs Post First Administration of Caffeine/Propranolol

    2 hours

  • Percentage of Participants Experiencing at Least One Adverse Event of Interest

    24 hours

  • Percentage of Participants With Treatment Satisfaction

    24 hours

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo to match caffeine/propranolol (single dose)

Drug: placebo

Low dose

EXPERIMENTAL

Participants will receive caffeine/propranolol 400/40 mg combination tablet (single dose)

Drug: caffeine/propranolol combination tablet

High dose

EXPERIMENTAL

Participants will receive caffeine/propranolol 1000/40 mg combination tablet (single dose)

Drug: caffeine/propranolol combination tablet

Interventions

caffeine/propranolol combination tabletDRUG

caffeine/propranolol combination tablet administered orally once daily

High doseLow dose
placeboDRUG

placebo to match caffeine/propranolol combination tablet administered orally once daily

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Subject is able to communicate adequately and comply with the requirements of the study as determined by the investigator.
  • \. Subject is able to read and understand the informed consent written in English and voluntarily consents to sign the informed consent form.

You may not qualify if:

  • \. Subject meets the criteria for complicated and/or brainstem migraines. 5. Subject is pregnant or lactating. 6. Subject has history of alcohol or drug abuse within the past 2 years. 7. Subject has existing systolic blood pressure \< 100mm Hg, existing systolic blood pressure \> 150mm Hg, and or heart rate \<50 beats per minute.
  • \. Subject has heart block greater than 1st degree without a functioning pacemaker 9. Subject has a history of tachyarrythmias 10. Subject has uncompensated congestive heart failure (CHF) 11. Subject has severe chronic obstructive pulmonary disease or severe asthma. 12. Subject has consumed caffeine within 6 hours. 13. Subjects with existing generalized anxiety disorder (GAD) and/or panic disorder.
  • \. Subjects with existing severe hepatic and/or renal insufficiency. 15. Subjects with existing Raynaud#s disease. 16. Subject is participating in another clinical trial during or within 30 days prior to study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Professor of Neurology
Organization
Stanford University School of Medicine
chos@stanford.edu
650-723-5184

Study Officials

  • S. Charles Cho

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 2, 2010

First Posted

March 4, 2010

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

February 24, 2017

Results First Posted

February 24, 2017

Record last verified: 2017-01

Locations

US(1)