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

NCT01135784 | Unknown Phase 2

• 1 other identifier: RZN 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• The reduction of migraine attacks

  The time-course and depth of the frequency in the reduction of migraine attacks

  90 Days

Secondary Outcomes (1)

• AEs SAEs

  90 days

Study Arms (2)

MIGRA-ZEN RELIEF PLUS

ACTIVE COMPARATOR

Active treatment

Dietary Supplement: MIGRA-ZEN RELIEF PLUS

Placebo for Migra zen plus

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo for Migrazen relief plus

Interventions

MIGRA-ZEN RELIEF PLUS DIETARY_SUPPLEMENT

one 2-capsule dose per 24hrs for a total of 180 caps over 90 days

MIGRA-ZEN RELIEF PLUS

Placebo for Migrazen relief plus DIETARY_SUPPLEMENT

2 capsule dose per 24 hours for 90 days

Placebo for Migra zen plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• RZN Nutraceuticals, Inc.: lead

Study Sites (2)

Rabin Medical Centre

Petah Tikva, Israel

Location

Sourasky Medical Centre

Tel Aviv, Israel

Location

Study Officials

• Amnon Mosek, MD

  Saurasky Tel Aviv Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Lubin, MD

CONTACT

305-971-3541; mark@rznnutra.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: June 3, 2010
• Study Start: October 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 14, 2011

Record last verified: 2011-03

Locations

IL (2)