Amyotrophic Lateral SclerosisPhase 2NCT00886977
Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study testing YAM80 in people with Amyotrophic Lateral Sclerosis, run by Yoshino Neurology Clinic at 1 site in Japan.
Trial summary
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- YAM80
- Type of treatment
- Pill or oral medicine
- How many people
- 25 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2009to Dec 2010
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 25 and 65 years
- ALS patients who can visit the clinic for six months
- Forced Vital Capacity (FVC) > 70%
- Patients who can walk by themselves
- Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
- Patients who are willing to give informed consent
Who cannot join
- Tracheotomy and invasive ventilation
- Pregnant or possibly pregnant female patients
- Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
- Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
- Patients who are being treated with investigational drugs
- Patients who are treated with other ALS drugs within 2 weeks prior to the first administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
The efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- YAM80
- Keywords
- ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YAM80Drug
Oral administration, 2 to 6 mg, once a day.
What is being measured
The primary outcome is the main question the study is designed to answer.
ALSFRS-R
Measured: 24w + follow-up period
Safety
Measured: 24w and the follow up period
Secondary outcomes (3)
Manual Muscle Testing
Measured: 24w + follow-up period
Grip/pinch strength
Measured: 24w + followup period
Pulmonary function (forced vital capacity)
Measured: 24w + follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yoshino Neurology Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Hiide Yoshino, M.D., Principal investigator, Yoshino Neurology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886977
- Sponsor's protocol ID
- YAM80-01
- Status last verified
- Apr 2009
- First submitted
- 21 Apr 2009
- Last updated
- 25 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Study of YAM80 in Amyotrophic Lateral Sclerosis. Evaluation of the Efficacy and Safety of YAM80 in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT00886977
- Acronym / sponsor ID
- YAM80-01
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- ALS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yoshino Neurology ClinicUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2010 (estimated)
- First posted
- 23 Apr 2009 (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 efficacy and safety are evaluated when YAM80 is administered orally to the patients of Amyotrophic Lateral Sclerosis (ALS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 25 and 65 years
- ALS patients who can visit the clinic for six months
- Forced Vital Capacity (FVC) > 70%
- Patients who can walk by themselves
- Change in ALSFRS-R score from -1 to -4 during 12 weeks before the initial administration
Key exclusion criteria (6 listed)
- Tracheotomy and invasive ventilation
- Pregnant or possibly pregnant female patients
- Female patients of childbearing potential who cannot practice contraception during and two years after the administration, and male patients who cannot practice contraception during and six months after the administration
- Patients with clinically significant conditions such as cardiovascular, respiratory, haematological, and renal diseases.
- Patients who are being treated with investigational drugs
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 |
|---|---|---|
| YAM80Oral administration, 2 to 6 mg, once a day. | Drug | – |
Primary outcome
ALSFRS-R
Time frame: 24w + follow-up period
Safety
Time frame: 24w and the follow up period
3 secondary outcomes
Manual Muscle Testing
Time frame: 24w + follow-up period
Grip/pinch strength
Time frame: 24w + followup period
Pulmonary function (forced vital capacity)
Time frame: 24w + follow-up period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2010.
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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.
Hiide Yoshino, M.D. principal investigator
Yoshino Neurology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YAM80 in people with Amyotrophic Lateral Sclerosis, run by Yoshino Neurology Clinic at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 25 Oct 2010. 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 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. 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?
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?
ALSFRS-R (time frame: 24w + follow-up period). The study lists 2 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 25 Oct 2010.