A Double-Blind Placebo-Controlled Trial of Rozerem in Mig... | NCT00391755

Studies
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

NCT00391755

Sponsor

Charlottesville Neuroscience

Status

Terminated

Last Update Posted

Feb 10, 2012Estimated

Enrollment

4Actual

Phase

Phase 4

Conditions

Migraine Headache

Interventions

ramelteon

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to recruit necessary number of patients.

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 22, 2006

First Submission Date that Met QC Criteria

Oct 23, 2006

First Posted Date

Oct 24, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2012

Last Update Posted Date

Feb 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patricia Shipley, MD, Principal Investigator, Charlottesville NeurosciencePrincipal Investigator

Lead Sponsor

Charlottesville NeuroscienceOTHER

Collaborators

Name	Class
Takeda Pharmaceuticals North America, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To study the effect of Rozerem, a high affinity MT1 and MT2, low affinity 5-HT2B receptor agonist used for insomnia, as a migraine prophylactic agent.

Detailed Description

In a recent, large study of migraineurs, over half reported difficulties with sleep initiation or maintenance. Those who had shorter average sleep times reported more severe headaches. Poor sleep has been associated with increased frequency and severity of migraines. The improvement of migraine frequency with improved sleep hygiene has been documented.

PET imaging has shown increased regional cerebral blood flow to neural structures involved in the sleep wake cycle during migraine headaches. Polysomnography has shown specific headache types to occur in specific sleep stages.

Melatonin has been effective primarily in headache due to delayed sleep phase syndrome. Recent studies support the efficacy of melatonin in treating migraine. The purpose of this study is to examine the efficacy of Rozerem as a prophylactic migraine medication. If effective, the benefits of the drug as a prophylactic agent for migraine include the tolerability of the drug and the possible secondary benefit of improvement in sleep.

Hypothesis: Rozerem will decrease migraine frequency due to the improvement in sleep and possibly due to the shared neurophysiology of sleep and migraine affected by melatonin.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	ramelteon 8 mg po qhs with sleep and migraine journal	Drug: ramelteon
2	Placebo Comparator	Placebo po qhs with sleep and migraine journal	Drug: ramelteon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ramelteon	Drug	ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Statistically significant reduction in migraine headaches in the Rozerem treated group.		4 months

Secondary Outcomes

Measure	Description	Time Frame
Improvement in sleep satisfaction in the Rozerem treated group.		4 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-65
3-8 Migraine headaches/month
Able to understand and comply with the study

Exclusion Criteria:

Currently on migraine prophylaxis
Currently on sleep medication > 4days/month
Currently on Fluvoxamine
Untreated psychiatric or sleep disorders
MRI abnormalities other than those attributable to migraine headaches
Abnormalities on neurological exam other than known neurological disorders unassociated with migraine or sleep
Known disorders of prolactin
Bipolar disorder
Hepatic disease
Pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patricia J Shipley, MD	Charlottesville Neuroscience	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Patricia Shipley, MD		Charlottesville	Virginia	22902	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
2406223	Background	Sahota PK, Dexter JD. Sleep and headache syndromes: a clinical review. Headache. 1990 Jan;30(2):80-4. doi: 10.1111/j.1526-4610.1990.hed3002080.x.
15985108	Background	Kelman L, Rains JC. Headache and sleep: examination of sleep patterns and complaints in a large clinical sample of migraineurs. Headache. 2005 Jul-Aug;45(7):904-10. doi: 10.1111/j.1526-4610.2005.05159.x.

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases