Spinocerebellar DegenerationPhase 3NCT01970137
A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
A Phase 3 study testing KPS-0373, High dose and KPS-0373, Low dose in people with Spinocerebellar Degeneration, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373) Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinocerebellar Degeneration
- What is being tested?
- KPS-0373, High dose and KPS-0373, Low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Start not givento Oct 2014
- 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 20 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)
Who cannot join
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
- Discontinuations in another clinical trials caused by side effects
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)
- Conditions
- Spinocerebellar Degeneration
- Being tested
- KPS-0373, High dose, KPS-0373, Low dose
- Keywords
- Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
- Medical subject headings
- Spinocerebellar Degenerations, Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPS-0373, High doseDrug
KPS-0373, Low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| KPS-0373 | Experimental | Not described Receives: Drug: KPS-0373, High dose; Drug: KPS-0373, Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARA (Scale for the Assessment and Rating of Ataxia)
Measured: 24 weeks
Secondary outcomes (1)
SF-8 (QOL)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar DegenerationStudies 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
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970137
- Sponsor's protocol ID
- KPS1304
- Status last verified
- Apr 2016
- First submitted
- 22 Oct 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Open-label Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
- ClinicalTrials.gov ID
- NCT01970137
- Acronym / sponsor ID
- KPS1304
- Conditions
- Spinocerebellar Degeneration
- Keywords
- Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH), Spinocerebellar Ataxia (SCA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Primary completion
- Oct 2014 (actual)
- First posted
- 25 Oct 2013 (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 evaluate the safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KPS-0373 | Experimental | Drug: KPS-0373, High dose, Drug: KPS-0373, Low dose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Japanese SCD patients with ataxia (Experience of clinical trials of KPS-0373)
Key exclusion criteria (3 listed)
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
- Discontinuations in another clinical trials caused by side effects
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 |
|---|---|---|
| KPS-0373, High dose | Drug | KPS-0373 |
| KPS-0373, Low dose | Drug | KPS-0373 |
Primary outcome
SARA (Scale for the Assessment and Rating of Ataxia)
Time frame: 24 weeks
1 secondary outcome
SF-8 (QOL)
Time frame: 24 weeks
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 18 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KPS-0373, High dose and KPS-0373, Low dose in people with Spinocerebellar Degeneration, run by Kissei Pharmaceutical Co., Ltd. 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 1 inclusion and 3 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 18 Apr 2016. 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 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?
SARA (Scale for the Assessment and Rating of Ataxia) (time frame: 24 weeks). 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 18 Apr 2016.