NCT00219869

Brief Summary

Most patients with CPTH present with additional major cognitive, behavioral and somatic problems. Most drugs used currently have a negative influence on cognition. Therefore, treatment strategies addressing both the headache and cognitive disturbances in patients with CPTH are necessary. (CPTH; Chronic Post Traumatic Headache).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Post-Traumatic HeadacheHead Trauma,ClosedRetention Disorders,Cognitive

Keywords

PostTraumaticHeadacheCognitive

Outcome Measures

Primary Outcomes (1)

  • Primary Headache Efficacy Measure; number of pain free days after 3 months

Secondary Outcomes (2)

  • Consumption of rescue medication

  • Number of days with moderate or severe headache after 3 months.

Interventions

GalantamineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age range 18-75 CPTH according to ICHD-2 Fertile woman using adequate birth control Willing and able to give informed consent Willing and able to complete the entire course of the study to comply with study instructions Stable does of preventive medication

You may not qualify if:

  • Subject is pregnant or lactating Significant medical or psychiatric disease Previous failure to 4 or more adequate trials of preventive medication Patient on non-stable dose of medication used to prevent CPTH

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New England Center for Headache

Stamford, Connecticut, 06902, United States

RECRUITING

MeSH Terms

Conditions

Post-Traumatic HeadacheHead Injuries, ClosedMemory DisordersHeadache

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesWounds, NonpenetratingNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Alan Rapoport, MD

    The New England Center for Headache

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lori L Flanagan, RN

CONTACT

203-322-2748lc@nech.net

Kathy Diomede, RN

CONTACT

203-322-2748kd@nech.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2005

Study Completion

August 1, 2005

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

US(1)