Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache (RZN)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Migraine
• Intervention / Treatment: Dietary supplement: MIGRA-ZEN RELIEF PLUS; Dietary supplement: Placebo for Migrazen relief plus

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mark Lubin, MD; Phone Number: 305-971-3541; Email: mark@rznnutra.com

Study Locations

• Israel
  • Petach Tikva, Israel
    • Rabin Medical Centre
    • Principal Investigator: Arie Koritzky, MD
  • Tel Aviv, Israel
    • Sourasky Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MIGRA-ZEN RELIEF PLUS; Active treatment	Dietary supplement: MIGRA-ZEN RELIEF PLUS; one 2-capsule dose per 24hrs for a total of 180 caps over 90 days
Placebo Comparator: Placebo for Migra zen plus; Placebo	Dietary supplement: Placebo for Migrazen relief plus; 2 capsule dose per 24 hours for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The reduction of migraine attacks	The time-course and depth of the frequency in the reduction of migraine attacks	90 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days

Collaborators and Investigators

• Sponsor: RZN Nutraceuticals, Inc.
• Investigators: Principal Investigator: Amnon Mosek, MD, Saurasky Tel Aviv Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): July 1, 2012

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: June 2, 2010
• First Posted (Estimate): June 3, 2010

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: RZN 1