Myasthenia GravisPhase 3NCT00309088
FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients
A Phase 3 study testing tacrolimus in people with Myasthenia Gravis, run by Astellas Pharma Inc at 9 sites in Japan.
Trial summary
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study. Read more about this study
- Who is it for?
- Ages 16 to 64 years
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 9 sitesJapan
- Study dates
- Apr 2006to Jun 2008
- Phase
- Phase 3
- 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 16 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinically diagnosed as myasthenia gravis
- Those whose MG symptoms are well-controlled by the treatment with prednisone
- Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain
Who cannot join
- Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
- Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
- Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
- Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
- Pancreatitis or diabetes
- Serum creatinine≦1.5mg/dL
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Study site
Chubu Region
Study site
Chugoku Region
Study site
Hokkaido Region
Study site
Hokuriku Region
Study site
Kansai Region
Study site
Kanto Region
Study site
Kyushu Region
Study site
Shikoku Region
Study site
Tohoku Region
About this study
Official title: FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
The purpose of the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
- Conditions
- Myasthenia Gravis
- Being tested
- tacrolimus, placebo
- Keywords
- Tacrolimus, Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimusDrug
Also called Prograf, FK506
oral
placeboDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: tacrolimus |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
Measured: 6 Months
Secondary outcomes (3)
Total amount of steroid therapy (mg)
Measured: 6 Months
QMG score;MG-ADL
Measured: 6 Months
Success rate of achievement to the targeted steroid dose
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study chair, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309088
- Sponsor's protocol ID
- F506-CL-0601
- Status last verified
- Aug 2014
- First submitted
- 29 Mar 2006
- Last updated
- 25 Aug 2014
- Results posted
- No
Publications
Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. doi: 10.1136/jnnp-2011-300148. Epub 2011 Jul 22.
PubMed 21784757
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients
- ClinicalTrials.gov ID
- NCT00309088
- Acronym / sponsor ID
- F506-CL-0601
- Conditions
- Myasthenia Gravis
- Keywords
- Tacrolimus, Myasthenia Gravis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 31 Mar 2006 (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 the study is to investigate the efficacy and safety for steroid non-resistant MG patients in a double blind, placebo controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: tacrolimus |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 16 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinically diagnosed as myasthenia gravis
- Those whose MG symptoms are well-controlled by the treatment with prednisone
- Steroid non-refractory Myasthenia Gravis: ≧20mg and ≦40mg / alternate day of steroid dose required to maintain
Key exclusion criteria (6 listed)
- Those who have thymoma or the history of thymoma (Masaoka stage III or IV)
- Patients who received steroid pulse therapy, plasma exchange therapy, globulin therapy or radiation therapy within 12 weeks prior to the initiation of test drug
- Patients who started the immunosuppressant therapy or increased the dose of immunosuppressant within 12 weeks prior to the initiation of test drug.
- Patients who had undergone thymectomy within 24 weeks prior to the initiation of test drug.
- Pancreatitis or diabetes
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 |
|---|---|---|
| tacrolimusAlso: Prograf, FK506oral | Drug | 1 |
| placebooral | Drug | 2 |
Primary outcome
Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.]
Time frame: 6 Months
3 secondary outcomes
Total amount of steroid therapy (mg)
Time frame: 6 Months
QMG score;MG-ADL
Time frame: 6 Months
Success rate of achievement to the targeted steroid dose
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Derived from this study: PubMed 21784757Yoshikawa H, Kiuchi T, Saida T, Takamori M. Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis. J Neurol Neurosurg Psychiatry. 2011 Sep;82(9):970-7. doi: 10.1136/jnnp-2011-300148. Epub 2011 Jul 22.
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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.
Central Contact study chair
Astellas Pharma Inc
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tacrolimus in people with Myasthenia Gravis, run by Astellas Pharma Inc at 9 sites in Japan.
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 6 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: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean dose of steroid to maintain minimal manifestation(MM)[The dose of steroid should be decreased by the rate of 5mg/alternate day/ 4 weeks after the initiation of tacrolimus or placebo treatment as far as the MM state should be maintained.] (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00309088, which also lists 1 linked publication.
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 25 Aug 2014.