Clinical trial NCT01135784: Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Migraine
Lead sponsor: RZN Nutraceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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).

Primary outcomes:
measure: The reduction of migraine attacks
timeFrame: 90 Days
Secondary outcomes:
measure: AEs SAEs
timeFrame: 90 days
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Centre
city: Tel Aviv
country: Israel
facility: Sourasky Medical Centre
Study officials:
affiliation: Saurasky Tel Aviv Medical Center, Israel
name: Amnon Mosek, MD
role: PRINCIPAL_INVESTIGATOR
References: