Severe Upper Limb HemiplegiaPhase 2NCT01623622
Study of HC-58 in Upper Limb Hemiplegic Patients After Stroke
A Phase 2 study testing HC-58 in people with Severe Upper Limb Hemiplegia, run by Asahi Kasei Therapeutics Corporation at 3 sites in Japan.
Trial summary
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Severe Upper Limb Hemiplegia
- What is being tested?
- HC-58
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2012to May 2015
- 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
- Patients with severe upper limb hemiplegia after stroke
- Within 28 days after stroke at enrollment
Who cannot join
- Patients with sensory loss between shoulder and hand on paralyzed side
- Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Fukui-shi, Fukui
Study site
Hamamatsu, Shizuoka
Study site
Kumamoto, Kumamoto
About this study
Official title: A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
- Conditions
- Severe Upper Limb Hemiplegia
- Being tested
- HC-58, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-58Drug
once or more / week
PlaceboDrug
once or more / week
| Study group | Role | What they receive |
|---|---|---|
| HC-58 low dose | Experimental | Low dose Receives: Drug: HC-58 |
| HC-58 high dose | Experimental | High dose Receives: Drug: HC-58 |
| 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.
Onset of shoulder hand syndrome
The incidence rate of shoulder hand syndrome
Measured: 12 weeks
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
MBI efficiency means MBI gain divided by period of administration
Measured: 12 weeks
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency
FMA efficiency means FMA gain divided by period of administration
Measured: 12 weeks
Secondary outcomes (7)
Pain score by numeric rating scale
Measured: 12 weeks
Swelling asymmetry between hands
Measured: 12 weeks
Discolouration of the skin of the hand
Measured: 12 weeks
Difference in skin temperature between hands
Measured: 12 weeks
Decreased range of motion
Measured: 12 weeks
Radiographic finding of bone
Measured: 12 weeks
Bone metabolic marker
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Upper Limb HemiplegiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshiya Umeda, Study director, Asahi Kasei Pharma Corporation Clinical Development Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623622
- Sponsor's protocol ID
- HC-58 (SHS) II-1
- Status last verified
- Feb 2015
- First submitted
- 18 Jun 2012
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
- ClinicalTrials.gov ID
- NCT01623622
- Acronym / sponsor ID
- HC-58 (SHS) II-1
- Conditions
- Severe Upper Limb Hemiplegia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 20 Jun 2012 (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 investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HC-58 low dose | Experimental | Drug: HC-58Low dose |
| HC-58 high dose | Experimental | Drug: HC-58High dose |
| 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 (2 listed)
- Patients with severe upper limb hemiplegia after stroke
- Within 28 days after stroke at enrollment
Key exclusion criteria (2 listed)
- Patients with sensory loss between shoulder and hand on paralyzed side
- Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
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 |
|---|---|---|
| HC-58once or more / week | Drug | HC-58 high dose, HC-58 low dose |
| Placeboonce or more / week | Drug | Placebo |
Primary outcome
Onset of shoulder hand syndrome
Time frame: 12 weeks
The incidence rate of shoulder hand syndrome
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
Time frame: 12 weeks
MBI efficiency means MBI gain divided by period of administration
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency
Time frame: 12 weeks
FMA efficiency means FMA gain divided by period of administration
7 secondary outcomes
Pain score by numeric rating scale
Time frame: 12 weeks
Swelling asymmetry between hands
Time frame: 12 weeks
Discolouration of the skin of the hand
Time frame: 12 weeks
Difference in skin temperature between hands
Time frame: 12 weeks
Decreased range of motion
Time frame: 12 weeks
Radiographic finding of bone
Time frame: 12 weeks
Bone metabolic marker
Time frame: 12 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 15 Feb 2017.
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.
Toshiya Umeda study director
Asahi Kasei Pharma Corporation Clinical Development Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HC-58 in people with Severe Upper Limb Hemiplegia, run by Asahi Kasei Therapeutics Corporation at 3 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 2 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 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
Onset of shoulder hand syndrome (time frame: 12 weeks). 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 15 Feb 2017.