Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache (RZN)
Primary Purpose
Chronic Migraine
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
MIGRA-ZEN RELIEF PLUS
Placebo for Migrazen relief plus
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Migraine
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects 18 years of age or older.
- Prior to this study subject must have been diagnosed with migraines according to IHS criteria by a qualified healthcare professional with some experience in the diagnosis of migraines and have suffered with them for one year prior to the start of the study.
- Migraine symptoms/attacks must have presented for a minimum of the last consecutive three (3) months at a minimum average frequency of six (6) times per month and must have been severe-extreme (grade 7-10) on a linear scale of 0-10, where 0=no pain and 10=unbearable maximum pain.
- Subjects who are able to follow the protocol as designed by RZN Nutraceuticals, Inc. and Teva Pharmaceutical Industries.
- Generally good health
Exclusion Criteria:
- Subjects currently taking any prophylactic treatment for migraine headaches
- History of head trauma or brain cancer.
- Candidate subjects with any medical condition that, in the opinion of the investigators or intake staff, would jeopardize the safety of the patient, affect the validity of the data collected from the subject, or would challenge the subject's ability to complete the study protocol for 90 days.
- Known renal insufficiency or kidney disease of any grade
- Any illness causing severe coughing so as to avoid introducing "coughing migraine" per IHS classification 4.2, G44.803.
- History of drug addiction.
- Females of child-bearing potential who do not practice medically acceptable methods of contraception surgical, sterilization, intrauterine device (IUD), hormonal preparations or double barrier method (e.g. condom or diaphragm and spermicide)
- Subjects with uncontrolled hypertension (e.g. BP>150/100).
Sites / Locations
- Rabin Medical Centre
- Sourasky Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MIGRA-ZEN RELIEF PLUS
Placebo for Migra zen plus
Arm Description
Active treatment
Placebo
Outcomes
Primary Outcome Measures
The reduction of migraine attacks
The time-course and depth of the frequency in the reduction of migraine attacks
Secondary Outcome Measures
AEs SAEs
The secondary end-points will be the absence/presence of detectable adverse liver function and urinalysis test results as well as the dearth/abundance of AE/SAE reports that may indicate patient safety/risk when using the IP.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01135784
Brief Title
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
Acronym
RZN
Official Title
Human CT: Efficacy & Safety of MIGRA-ZEN RELIEF PLUS:Herbal Supp:Extracts Juniper Willow Goldenrod Dandelion Meadowsweet Whole Grape In Rx of Chronic Migraine Headache. Randomized, Double-Blind, Placebo Cont. Study P.II (PoC Study)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
RZN Nutraceuticals, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to study MIGRA-ZEN RELIEF PLUS, an all-natural herbal dietary supplement product, with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically. This study will involve subjects suffering from chronic migraine headaches.
Detailed Description
The purpose of this 90-day, randomized, double-blind, placebo controlled study is to evaluate the efficacy of an all-natural herbal dietary supplement product, (Investigational Product, or IP), with respect to alleviating and/or stopping migraine headache pain compared to a placebo when used prophylactically every day, and to evaluate the safety/risk of its use by observing the absence/presence of adverse event (AE/SAE) reports and the normalcy of blood work, urinalysis, and liver enzyme tests. The primary end-point is the time-course and depth of the frequency reduction of migraine attacks. The secondary end-points will be the absence/presence of detectable adverse liver function and urinalysis test results as well as the dearth/abundance of AE/SAE reports that may indicate patient safety/risk when using the IP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MIGRA-ZEN RELIEF PLUS
Arm Type
Active Comparator
Arm Description
Active treatment
Arm Title
Placebo for Migra zen plus
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
MIGRA-ZEN RELIEF PLUS
Intervention Description
one 2-capsule dose per 24hrs for a total of 180 caps over 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo for Migrazen relief plus
Intervention Description
2 capsule dose per 24 hours for 90 days
Primary Outcome Measure Information:
Title
The reduction of migraine attacks
Description
The time-course and depth of the frequency in the reduction of migraine attacks
Time Frame
90 Days
Secondary Outcome Measure Information:
Title
AEs SAEs
Description
The secondary end-points will be the absence/presence of detectable adverse liver function and urinalysis test results as well as the dearth/abundance of AE/SAE reports that may indicate patient safety/risk when using the IP.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female subjects 18 years of age or older.
Prior to this study subject must have been diagnosed with migraines according to IHS criteria by a qualified healthcare professional with some experience in the diagnosis of migraines and have suffered with them for one year prior to the start of the study.
Migraine symptoms/attacks must have presented for a minimum of the last consecutive three (3) months at a minimum average frequency of six (6) times per month and must have been severe-extreme (grade 7-10) on a linear scale of 0-10, where 0=no pain and 10=unbearable maximum pain.
Subjects who are able to follow the protocol as designed by RZN Nutraceuticals, Inc. and Teva Pharmaceutical Industries.
Generally good health
Exclusion Criteria:
Subjects currently taking any prophylactic treatment for migraine headaches
History of head trauma or brain cancer.
Candidate subjects with any medical condition that, in the opinion of the investigators or intake staff, would jeopardize the safety of the patient, affect the validity of the data collected from the subject, or would challenge the subject's ability to complete the study protocol for 90 days.
Known renal insufficiency or kidney disease of any grade
Any illness causing severe coughing so as to avoid introducing "coughing migraine" per IHS classification 4.2, G44.803.
History of drug addiction.
Females of child-bearing potential who do not practice medically acceptable methods of contraception surgical, sterilization, intrauterine device (IUD), hormonal preparations or double barrier method (e.g. condom or diaphragm and spermicide)
Subjects with uncontrolled hypertension (e.g. BP>150/100).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Lubin, MD
Phone
305-971-3541
Email
mark@rznnutra.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amnon Mosek, MD
Organizational Affiliation
Saurasky Tel Aviv Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Centre
City
Petach Tikva
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arie Koritzky, MD
Facility Name
Sourasky Medical Centre
City
Tel Aviv
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amnon Mosek, MD
12. IPD Sharing Statement
Learn more about this trial
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
We'll reach out to this number within 24 hrs