NCT00391755

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

October 1, 2006

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

3 years

First QC Date

October 22, 2006

Last Update Submit

February 8, 2012

Conditions

Migraine Headache

Keywords

Migraine Headache

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

  • Improvement in sleep satisfaction in the Rozerem treated group.

    4 months

Study Arms (2)

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

ramelteonDRUG

1. ramelteon 8mg po qhs with sleep and headache diary 2. placebo 1 po qhs with sleep and headache diary

Also known as: Rozerem
12

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia Shipley, MD

Charlottesville, Virginia, 22902, United States

Location

Related Publications (7)

  • 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.

    PMID: 2406223BACKGROUND

  • 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.

    PMID: 15985108BACKGROUND

  • 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.

    PMID: 15953298BACKGROUND

  • 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.

    PMID: 10668125BACKGROUND

  • 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.

    PMID: 11293599BACKGROUND

  • 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.

    PMID: 15910564BACKGROUND

  • 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.

    PMID: 15326268BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

ramelteon

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Patricia J Shipley, MD

    Charlottesville Neuroscience

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2006

First Posted

October 24, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

US(1)