SCDPhase 2NCT01384435
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
A Phase 2 study testing KPS-0373 in people with SCD, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- SCD
- What is being tested?
- KPS-0373
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese SCD patients with mild to moderate ataxia
Who cannot join
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).
- Conditions
- SCD
- Being tested
- KPS-0373, Placebo
- Keywords
- Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH)
- Medical subject headings
- Spinocerebellar Degenerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KPS-0373Drug
KPS-0373Drug
KPS-0373Drug
KPS-0373Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| KPS-0373, lowest dose | Experimental | Not described Receives: Drug: KPS-0373 |
| KPS-0373, 2nd lowest dose | Experimental | Not described Receives: Drug: KPS-0373 |
| KPS-0373, 2nd highest dose | Experimental | Not described Receives: Drug: KPS-0373 |
| KPS-0373, highest dose | Experimental | Not described Receives: Drug: KPS-0373 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Scale for the assessment and rating of ataxia (SARA)
Measured: 24 weeks
Secondary outcomes (1)
Change from baseline in patient improvement impression of activities of daily living
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 posted29 Jun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCDStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Katsumi Hontani, Study director, Clinical Research Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384435
- Sponsor's protocol ID
- KPS1203
- Status last verified
- Mar 2012
- First submitted
- 23 Jun 2011
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-controlled Phase II Study of KPS-0373 in Patients With SCD
- ClinicalTrials.gov ID
- NCT01384435
- Acronym / sponsor ID
- KPS1203
- Conditions
- SCD
- Keywords
- Spinocerebellar degeneration (SCD), Thyrotropin-Releasing Hormone (TRH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 Jun 2011 (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 efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| KPS-0373, lowest dose | Experimental | Drug: KPS-0373 |
| KPS-0373, 2nd lowest dose | Experimental | Drug: KPS-0373 |
| KPS-0373, 2nd highest dose | Experimental | Drug: KPS-0373 |
| KPS-0373, highest dose | Experimental | Drug: KPS-0373 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Japanese SCD patients with mild to moderate ataxia
Key exclusion criteria (2 listed)
- Patients with secondary ataxia
- Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
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 | Drug | KPS-0373, lowest dose |
| KPS-0373 | Drug | KPS-0373, 2nd lowest dose |
| KPS-0373 | Drug | KPS-0373, 2nd highest dose |
| KPS-0373 | Drug | KPS-0373, highest dose |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in Scale for the assessment and rating of ataxia (SARA)
Time frame: 24 weeks
1 secondary outcome
Change from baseline in patient improvement impression of activities of daily living
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 3 Dec 2012.
Related trials for SCD
Not yet recruitingPhase 1
Minocycline In Neurocognitive Outcomes - Sickle Cell Disease
Sickle Cell Disease, Cognitive Impairment
RecruitingPhase 2
Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)
Sickle Cell Disease
Not yet recruitingObservational study
Data Collection For Patients With Sickle Cell Disease
Data Collection, Sickle Cell Disease
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Not yet recruiting
Hypoxic Red Blood Cells in Sickle Cell Anemia
Sickle Cell Anaemia, Sickle Cell Anemia Crisis
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.
Katsumi Hontani study director
Clinical Research Dept.
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 KPS-0373 in people with SCD, 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 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: finished, as of the sponsor's last update on 3 Dec 2012. 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. 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?
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?
Change from baseline in Scale for the assessment and rating of ataxia (SARA) (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 3 Dec 2012.