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

RZN Nutraceuticals

Status and phase: Unknown; Phase 2

Conditions: Chronic Migraine

Treatments: Dietary Supplement: MIGRA-ZEN RELIEF PLUS; Dietary Supplement: Placebo for Migrazen relief plus

Study type: Interventional

Funder types: Industry

Identifiers

NCT01135784

RZN 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

MIGRA-ZEN RELIEF PLUS

Active Comparator group

Description:

Active treatment

Treatment:

Dietary Supplement: MIGRA-ZEN RELIEF PLUS

Placebo for Migra zen plus

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo for Migrazen relief plus