Galantamine in the Treatment of Post-Traumatic Headache
Recruitment status was Recruiting
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Headache Head Trauma,Closed Retention Disorders,Cognitive |
Drug: Galantamine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Galantamine in the Preventive Treatment of Chronic Post-Traumatic Headache |
- Primary Headache Efficacy Measure; number of pain free days after 3 months
- Consumption of rescue medication
- Number of days with moderate or severe headache after 3 months.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | August 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
-
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
-
Contacts and Locations| Contact: Lori L Flanagan, RN | 203-322-2748 | lc@nech.net |
| Contact: Kathy Diomede, RN | 203-322-2748 | kd@nech.net |
| United States, Connecticut | |
| The New England Center for Headache | Recruiting |
| Stamford, Connecticut, United States, 06902 | |
| Contact: Lori Flanagan, RN 203-322-2748 lc@nech.net | |
| Contact: Kathy Diomede 203-322-2748 kd@nech.net | |
| Principal Investigator: Alan Rapoport, MD | |
| Sub-Investigator: Stewart Tepper, MD | |
| Sub-Investigator: Fred Sheftell, MD | |
| Sub-Investigator: Marcelo Bigal, MD, PhD | |
| Principal Investigator: | Alan Rapoport, MD | The New England Center for Headache |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00219869 History of Changes |
| Other Study ID Numbers: | GAL-EMR-4006 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Rapoport, Alan, M.D.:
|
Post Traumatic Headache Cognitive |
Additional relevant MeSH terms:
|
Headache Post-Traumatic Headache Headache Disorders, Secondary Headache Disorders Craniocerebral Trauma Memory Disorders Urinary Retention Head Injuries, Closed Trauma, Nervous System Nervous System Diseases Wounds and Injuries Pain Neurologic Manifestations Signs and Symptoms Neurobehavioral Manifestations |
Brain Diseases Central Nervous System Diseases Urination Disorders Urologic Diseases Wounds, Nonpenetrating Galantamine Parasympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nootropic Agents Central Nervous System Agents Therapeutic Uses Cholinesterase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013