| CTRI Number |
CTRI/2013/11/004172 [Registered on: 27/11/2013] Trial Registered Prospectively |
| Last Modified On: |
11/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the beneficial effects of drug memantine for the prevention of migraine headache |
|
Scientific Title of Study
|
Evaluation of Memantine for migraine prophylaxis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr V Sathya narayanan |
| Designation |
Professor Of Pharmacology |
| Affiliation |
SRM University |
| Address |
SRM Medical College
potheri
kattankolathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
919384633405 |
| Fax |
|
| Email |
satya672000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kranthi |
| Designation |
PG student |
| Affiliation |
SRM University |
| Address |
SRM Medical College
potheri
kattankolathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
drkranthi10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundar |
| Designation |
Assistant Professor of Neurology |
| Affiliation |
SRM University |
| Address |
SRM Medical College
potheri
kattankolathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
drradnus@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| SRM University, Potheri, Kattankolathur post, Kanchipuram Dt, Tamil Nadu Pin 603 203 |
|
|
Primary Sponsor
|
| Name |
SRM University |
| Address |
Potheri
Kattankolathur
Kancheepuram |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM University |
Potheri
Kattankolathur
Kancheepuram |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr V Sathya narayanan |
Headahe clinic, Depatment of Neurology |
SRM MCH RC
potheri
kattankolathur
Kancheepuram
TAMIL NADU |
919384633405
satya672000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
migraine , (1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Memantine |
memantine tablets, 10 mg once daily, orally for 6 months |
| Comparator Agent |
Placebo pills |
sugar pills looking like interventional drug, as tablets, given once daily, orally for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in migraine assessed by Headache frequency and severity monitored with headache diary
|
at the end of each month for 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of migraine ( MIDAS - Migraine Disability Assessment Test )
Duration ( Duration of migraine)
No of days in a month requiring rescue medication
Quality of life (MSQ - Migraine-Specific Quality of Life Questionnaire )
|
at the end of each month for 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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 | | |
|