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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by RZN Nutraceuticals, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
RZN Nutraceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01135784
First received: May 26, 2010
Last updated: June 13, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Chronic Migraine
Dietary Supplement: MIGRA-ZEN RELIEF PLUS
Dietary Supplement: Placebo for Migrazen relief plus
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by RZN Nutraceuticals, Inc.:

Primary Outcome Measures:
  • The reduction of migraine attacks [ Time Frame: 90 Days ] [ Designated as safety issue: Yes ]
    The time-course and depth of the frequency in the reduction of migraine attacks


Secondary Outcome Measures:
  • AEs SAEs [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135784

Contacts
Contact: Mark Lubin, MD 305-971-3541 mark@rznnutra.com

Locations
Israel
Rabin Medical Centre Not yet recruiting
Petach Tikva, Israel
Principal Investigator: Arie Koritzky, MD         
Sourasky Medical Centre Not yet recruiting
Tel Aviv, Israel
Principal Investigator: Amnon Mosek, MD         
Sponsors and Collaborators
RZN Nutraceuticals, Inc.
Investigators
Principal Investigator: Amnon Mosek, MD Saurasky Tel Aviv Medical Center, Israel
  More Information

No publications provided

Responsible Party: Mark Lubin, CEO & Chief Scientist, RZN Nutraceutricals, Inc.
ClinicalTrials.gov Identifier: NCT01135784     History of Changes
Other Study ID Numbers: RZN 1
Study First Received: May 26, 2010
Last Updated: June 13, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014