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
Recruitment status was Not yet recruiting
Sponsor:
RZN Nutraceuticals, Inc.
Information provided by:
RZN Nutraceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01135784
First received: May 26, 2010
Last updated: June 13, 2011
Last verified: March 2011
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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 June 17, 2013