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| Name | Class |
|---|---|
| Ortho-McNeil Neurologics, Inc. | INDUSTRY |
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).
Headache is the most common symptom after a closed head injury, persisting for more then 2 months in 60% of the patients. CPTH is an important cause of consultations in neurology offices and headache clinics, posing a severe burden and affecting the quality of life of sufferers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Headache Efficacy Measure; number of pain free days after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Consumption of rescue medication | ||
| Number of days with moderate or severe headache after 3 months. |
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Inclusion Criteria:
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
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Exclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lori L Flanagan, RN | Contact | 203-322-2748 | lc@nech.net | |
| Kathy Diomede, RN | Contact | 203-322-2748 | kd@nech.net |
| Name | Affiliation | Role |
|---|---|---|
| Alan Rapoport, MD | The New England Center for Headache | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New England Center for Headache | Recruiting | Stamford | Connecticut | 06902 | United States |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D016489 | Head Injuries, Closed |
| D008569 | Memory Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |