Trial record 13 of 455 for:
"Migraine Disorders"
Preventive Treatment of Episodic and Chronic Migraine
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by California Medical Clinic for Headache.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
California Medical Clinic for Headache
Information provided by:
California Medical Clinic for Headache
ClinicalTrials.gov Identifier:
NCT01319825
First received: March 18, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
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Purpose
This is an open label pilot study to determine whether milnacipran can reduce headache frequency in episodic and chronic migraine sufferers.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine With Aura Migraine Without Aura Chronic Migraine |
Drug: milnacipran |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Open Label Study of Milnacipran in the Preventive Treatment of Episodic Migraine With and Without Aura and Chronic Migraine. |
Resource links provided by NLM:
Further study details as provided by California Medical Clinic for Headache:
Primary Outcome Measures:
- Reduction in number of all headache days per month in the last month of stable dosing, compared to baseline [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction in number of migraine days per month in the last month of stable dosing compared to baseline. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Improvement in headache index score [ Time Frame: 4 months ] [ Designated as safety issue: No ]Headache index is defined by headache severity x headache duration.
- Reduction in the number of days of headache related disability/impairment [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Assessment of adverse events
- Use of rescue medications [ Time Frame: 4 months ] [ Designated as safety issue: No ]To assess the continued need for acute headache treatments during the study period.
- Quality of life measures [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: milnacipran
100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
Patients with episodic migraine with and/or without aura and chronic migraine will be treated with 100 or 200 mg of milnacipran for a total of 4 months including a one month titration phase and a 3 month maintenance phase. Baseline (pre-treatment) and end-of-maintenance phase headache frequencies will be recorded. There is no placebo treatment in this study. In addition to headache frequencies, other parameters being measured include safety and tolerability.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Migraine with or without aura or chronic migraine.
- Subject age 18 to 70.
- At least 2 migraine attacks per month.
- Willing ang able to give written informed consent.
- Willing and able to complete the entire course of the study and to comply with study instructions.
- Willing to taper and discontinue their current preventive medications.
Exclusion Criteria:
- Subject is pregnant, lactating or planning a pregnancy in the next year.
- Subject is female of child-bearing potential and not taking adequate forms of birth control.
- Significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
- Previous failure of four or more adequate trials of preventive medication.
- Currently on any form of antidepressant for depression and not able to discontinue.
- Currently demonstrating medication overuse headache.
- Currently has uncontrolled narrow angle glaucoma.
- Currently taking monoamine oxidase inhibitors.
- Subject has a history of seizures.
- Participation in an investigational drug study within the last 30 days or 5 half-lives, whichever is longer.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01319825
Contacts
| Contact: David B Kudrow, MD | 310-315-1456 | dbkudrow@earthlink.net |
Locations
| United States, California | |
| California Medical Clinic for Headache | Not yet recruiting |
| Santa Monica, California, United States, 90404 | |
| Contact: Tatyana Neyman, MD 310-315-1456 tneyman@drkudrow.com | |
| Sub-Investigator: Alan Rapoport, MD | |
Sponsors and Collaborators
California Medical Clinic for Headache
Investigators
| Principal Investigator: | David B Kudrow, MD | California Medical Clinic for Headache |
More Information
Additional Information:
No publications provided
| Responsible Party: | David Kudrow, M.D., California Medical Clinic for Headache |
| ClinicalTrials.gov Identifier: | NCT01319825 History of Changes |
| Other Study ID Numbers: | SAV-MD-26 |
| Study First Received: | March 18, 2011 |
| Last Updated: | March 18, 2011 |
| Health Authority: | United States: Food and Drug Aministration. |
Additional relevant MeSH terms:
|
Migraine Disorders Migraine with Aura Migraine without Aura Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Milnacipran Antidepressive Agents Psychotropic Drugs |
Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013