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

Primary Purpose

Migraine Headache

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ramelteon
Sponsored by
Charlottesville Neuroscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headache focused on measuring Migraine Headache

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Patricia Shipley, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

ramelteon 8 mg po qhs with sleep and migraine journal

Placebo po qhs with sleep and migraine journal

Outcomes

Primary Outcome Measures

Statistically significant reduction in migraine headaches in the Rozerem treated group.

Secondary Outcome Measures

Improvement in sleep satisfaction in the Rozerem treated group.

Full Information

First Posted
October 22, 2006
Last Updated
February 8, 2012
Sponsor
Charlottesville Neuroscience
Collaborators
Takeda Pharmaceuticals North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00391755
Brief Title
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Official Title
A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Failure to recruit necessary number of patients.
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charlottesville Neuroscience
Collaborators
Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
Keywords
Migraine Headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
ramelteon 8 mg po qhs with sleep and migraine journal
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo po qhs with sleep and migraine journal
Intervention Type
Drug
Intervention Name(s)
ramelteon
Other Intervention Name(s)
Rozerem
Intervention Description
ramelteon 8mg po qhs with sleep and headache diary placebo 1 po qhs with sleep and headache diary
Primary Outcome Measure Information:
Title
Statistically significant reduction in migraine headaches in the Rozerem treated group.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Improvement in sleep satisfaction in the Rozerem treated group.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia J Shipley, MD
Organizational Affiliation
Charlottesville Neuroscience
Official's Role
Principal Investigator
Facility Information:
Facility Name
Patricia Shipley, MD
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2406223
Citation
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.
Results Reference
background
PubMed Identifier
15985108
Citation
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.
Results Reference
background
PubMed Identifier
15953298
Citation
Boardman HF, Thomas E, Millson DS, Croft PR. Psychological, sleep, lifestyle, and comorbid associations with headache. Headache. 2005 Jun;45(6):657-69. doi: 10.1111/j.1526-4610.2005.05133.x.
Results Reference
background
PubMed Identifier
10668125
Citation
Bruni O, Galli F, Guidetti V. Sleep hygiene and migraine in children and adolescents. Cephalalgia. 1999 Dec;19 Suppl 25:57-9. doi: 10.1177/0333102499019s2516.
Results Reference
background
PubMed Identifier
11293599
Citation
Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7. doi: 10.1016/s0140-6736(00)04250-1.
Results Reference
background
PubMed Identifier
15910564
Citation
Peres MF. Melatonin, the pineal gland and their implications for headache disorders. Cephalalgia. 2005 Jun;25(6):403-11. doi: 10.1111/j.1468-2982.2005.00889.x.
Results Reference
background
PubMed Identifier
15326268
Citation
Peres MF, Zukerman E, da Cunha Tanuri F, Moreira FR, Cipolla-Neto J. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757. doi: 10.1212/01.wnl.0000134653.35587.24. No abstract available.
Results Reference
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A Double-Blind Placebo-Controlled Trial of Rozerem in Migraine Headaches

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