Status:
UNKNOWN
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
Lead Sponsor:
RZN Nutraceuticals, Inc.
Conditions:
Chronic Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01135784
Start Date
October 1 2011
End Date
July 1 2012
Last Update
June 14 2011
Active Locations (2)
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1
Rabin Medical Centre
Petah Tikva, Israel
2
Sourasky Medical Centre
Tel Aviv, Israel