Chronic MigrainePhase 2RZNNCT01135784
Study of MIGRA-ZEN RELIEF PLUS In the Treatment of Chronic Migraine Headache
A Phase 2 study testing MIGRA-ZEN RELIEF PLUS in people with Chronic Migraine, run by RZN Nutraceuticals, Inc. at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- MIGRA-ZEN RELIEF PLUS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Oct 2011to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Israel2 sites
Rabin Medical Centre
Petah Tikva
Arie Koritzky, MD
Sourasky Medical Centre
Tel Aviv
Amnon Mosek, MD
About this study
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)
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.
Read the 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.
- Conditions
- Chronic Migraine
- Being tested
- MIGRA-ZEN RELIEF PLUS, Placebo for Migrazen relief plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIGRA-ZEN RELIEF PLUSDietary supplement
one 2-capsule dose per 24hrs for a total of 180 caps over 90 days
Placebo for Migrazen relief plusDietary supplement
2 capsule dose per 24 hours for 90 days
| Study group | Role | What they receive |
|---|---|---|
| MIGRA-ZEN RELIEF PLUS | Active comparator | Active treatment Receives: Dietary Supplement: MIGRA-ZEN RELIEF PLUS |
| Placebo for Migra zen plus | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo for Migrazen relief plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reduction of migraine attacks
The time-course and depth of the frequency in the reduction of migraine attacks
Measured: 90 Days
Secondary outcomes (1)
AEs SAEs
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startOct 2011
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RZN Nutraceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Amnon Mosek, MD, Principal investigator, Saurasky Tel Aviv Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135784
- Sponsor's protocol ID
- RZN 1
- Acronym
- RZN
- Status last verified
- Mar 2011
- First submitted
- 26 May 2010
- Last updated
- 14 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01135784
- Acronym / sponsor ID
- RZN / RZN 1
- Conditions
- Chronic Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- RZN Nutraceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIGRA-ZEN RELIEF PLUS | Active comparator | Dietary Supplement: MIGRA-ZEN RELIEF PLUSActive treatment |
| Placebo for Migra zen plus | Placebo comparator | Dietary Supplement: Placebo for Migrazen relief plusPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIGRA-ZEN RELIEF PLUSone 2-capsule dose per 24hrs for a total of 180 caps over 90 days | Dietary supplement | MIGRA-ZEN RELIEF PLUS |
| Placebo for Migrazen relief plus2 capsule dose per 24 hours for 90 days | Dietary supplement | Placebo for Migra zen plus |
Primary outcome
The reduction of migraine attacks
Time frame: 90 Days
The time-course and depth of the frequency in the reduction of migraine attacks
1 secondary outcome
AEs SAEs
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amnon Mosek, MD principal investigator
Saurasky Tel Aviv Medical Center, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MIGRA-ZEN RELIEF PLUS in people with Chronic Migraine, run by RZN Nutraceuticals, Inc. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Lubin, MD (305-971-3541, mark@rznnutra.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reduction of migraine attacks (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2011.