Evaluation of Memantine for migraine prophylaxis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- improvement in migraine assessed by Headache frequency and severity monitored with headache diary
研究概览
简要总结
Migraine headache is a neurological disorder associated with significant disability and impaired quality of life, adversely affecting daily activity and work-related productivity for many persons.
Furthermore, most migraine patients require bed rest in addition to medication, indicating that migraine continues to significantly affect their lives.
Despite the existence of multiple well established migraine preventive therapies, there is a significant proportion of migraine patients for whom currently available therapies are either ineffective or poorly tolerated.
Memantine is a moderate-affinity uncompetitive NMDA receptor antagonist that is approved in the U.S. for the treatment of Alzheimer’s disease.
This antagonist, which has fewer side effects than other NMDA antagonists, is believed to work by competing with magnesium in the synapse, which inhibits the prolonged influx of calcium.
This inhibition blocks neuronal excitation or CSD and therefore is thought to inhibit migraine pain.
Hence this study is undertaken to evaluate the efficacy and safety of memantine in migraine patients,without affecting the physiological functions.
OBJECTIVES OF THIS STUDY
—Primary objective is to evaluate whether memantine as monotherapy has a prophylactic effect in migraine compared with placebo
—Secondary objective is to evaluate Whether memantine therapy can improve the quality of life
Study Type : Interventional
Study Design: Allocation: Randomized controlled
Masking: Double-Blind
Study place : Headache clinic of Department of Neurology in SRM Hospital & research centre,
kattankulathur.
Study population : Patients attending headache clinic in SRM Hospital Neurology
department.with Inclusion Criteria and Exclusion Criteria as mentioned
Primary Outcome Measures:
Ø —Headache frequency and severity monitored with headache diary
Secondary Outcome Measures:
Severity of migraine ( MIDAS - Migraine Disability Assessment Test )
Ø Duration ( Duration of migraine)
Ø No of days in a month requiring rescue medication
Ø Quality of life (MSQ - Migraine-Specific Quality of Life Questionnaire )
| Estimated Enrollment: |
60 ( 30 memantine group & 30 placebo group)
|Study Start Date:
Jan 2014
|Study Completion Date:
June 2014
|
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with of migraine as assessed by International Headache Society (IHS) criteria, for at least 6 months before screening patients with between 3 and 12 migraines but no more than 15 headache days Patients willing to give consent.
排除标准
- •Patients having headaches other than migraine, episodic tension, or sinus headaches.
- •If headaches failed to respond to more than 2 adequate previous regimens of migraine preventive medications Medication overuse headache Pregnant/breast feeding women Severe medical illness renal insufficiency Hypersensitivity.
结局指标
主要结局
improvement in migraine assessed by Headache frequency and severity monitored with headache diary
时间窗: at the end of each month for 6 months
Study Start Date :
时间窗: Jan 2014
Study Completion Date :
时间窗: June 2014
次要结局
- Severity of migraine ( MIDAS - Migraine Disability Assessment Test )(Duration ( Duration of migraine))
- Study Start Date(:)
- Study Completion Date(:)