FibromyalgiaNCT01219049
L-Tyrosine Supplementation in Patients With Fibromyalgia
A study testing Tyrosine in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Tyrosine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2011
- Phase
- Interventional
- 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
- Diagnosis of fibromyalgia
- Pain greater than 4/10
- Age greater than 18
Who cannot join
- Pregnant
- Age less than 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. The investigators hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.
Read the detailed description
Fibromyalgia is a chronic pain syndrome with few treatment options available. The amino-acid L-tyrosine is the precursor for norepinephrine in the central nervous system (CNS). Norepinephrine in the CNS has important roles in pain and mood modulation and descending inhibition of pain pathways. By giving the precursor L-tyrosine in high doses we believe that we can increase levels of norepinephrine in the CNS. To study this question we designed a randomized blinded pilot study of 30 patients. Patients are randomly assigned to one of 3 groups (placebo, tyrosine 1000mg/day, and tyrosine 2000mg/day.) for 3 weeks. Patients then complete the Brief Pain Inventory (BPI) daily and the Fibromyalgia impact questionnaire (FIQ) on day 1 and day 21. Patients also complete a drug diary. They are monitored weekly for progress during the study.
- Conditions
- Fibromyalgia
- Being tested
- Tyrosine, Placebo
- Keywords
- Diet, Fibromyalgia, Pain, Drug, Amino-acid, Fatigue
- Medical subject headings
- Fibromyalgia, Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TyrosineDrug
1000 mg / day
TyrosineDrug
2000 mg / day
PlaceboDrug
Placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Tyrosine 1000 mg / day | Experimental | Patients receive 1000 mg tyrosine per day. Receives: Drug: Tyrosine |
| Tyrosine 2000 mg / day | Experimental | Patients receive 2000 mg tyrosine per day. Receives: Drug: Tyrosine |
| Placebo | Placebo comparator | Patients receive placebo daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Measured: daily for 21 days
FIQ Score
Measured: Day 1
FIQ Score
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Due to FDA comments, changes required unavailable resources. There are no results for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael A Mazzeffi, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219049
- Sponsor's protocol ID
- 09-1144
- Status last verified
- Apr 2017
- First submitted
- 8 Oct 2010
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Tyrosine Supplementation in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01219049
- Acronym / sponsor ID
- 09-1144
- Conditions
- Fibromyalgia
- Keywords
- Diet, Fibromyalgia, Pain, Drug, Amino-acid, Fatigue
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to FDA comments, changes required unavailable resources. There are no results for this study.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Oct 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.
Patients in the study, who have a diagnosis of fibromyalgia, will be randomly assigned to take the amino acid L-tyrosine or placebo (blank pill) for 3 weeks. They will fill out questionnaires about their symptoms and see if they have any improvement. The investigators hypothesis is that taking tyrosine will help alleviate the symptoms of fibromyalgia.
Detailed description
Fibromyalgia is a chronic pain syndrome with few treatment options available. The amino-acid L-tyrosine is the precursor for norepinephrine in the central nervous system (CNS). Norepinephrine in the CNS has important roles in pain and mood modulation and descending inhibition of pain pathways. By giving the precursor L-tyrosine in high doses we believe that we can increase levels of norepinephrine in the CNS. To study this question we designed a randomized blinded pilot study of 30 patients. Patients are randomly assigned to one of 3 groups (placebo, tyrosine 1000mg/day, and tyrosine 2000mg/day.) for 3 weeks. Patients then complete the Brief Pain Inventory (BPI) daily and the Fibromyalgia impact questionnaire (FIQ) on day 1 and day 21. Patients also complete a drug diary. They are monitored weekly for progress during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tyrosine 1000 mg / day | Experimental | Drug: TyrosinePatients receive 1000 mg tyrosine per day. |
| Tyrosine 2000 mg / day | Experimental | Drug: TyrosinePatients receive 2000 mg tyrosine per day. |
| Placebo | Placebo comparator | Drug: PlaceboPatients receive placebo daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of fibromyalgia
- Pain greater than 4/10
- Age greater than 18
Key exclusion criteria (2 listed)
- Pregnant
- Age less than 18
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 |
|---|---|---|
| Tyrosine1000 mg / day | Drug | Tyrosine 1000 mg / day |
| Tyrosine2000 mg / day | Drug | Tyrosine 2000 mg / day |
| PlaceboPlacebo daily | Drug | Placebo |
Primary outcome
Pain Score
Time frame: daily for 21 days
FIQ Score
Time frame: Day 1
FIQ Score
Time frame: Day 21
Results and safety
The study was stopped early (reason given: Due to FDA comments, changes required unavailable resources. There are no results for this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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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.
Michael A Mazzeffi, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tyrosine in people with Fibromyalgia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
The study was stopped early (reason given: Due to FDA comments, changes required unavailable resources. There are no results for this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: daily for 21 days). The study lists 3 primary outcomes in all. 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 11 Apr 2017.