Muscle SpasticitySTRETChNCT02145650
Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs
An observational study of Muscle Spasticity, run by Allergan at 1 site in United States.
Trial summary
This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Muscle Spasticity
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Aug 2015
- Phase
- Observational
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI in clinical practice evaluated for spasticity.
Who may be able to join
- -Diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI) for a minimum of 3 months
Who cannot join
- -Participation in a spasticity clinical trial in the past 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI).
- Conditions
- Muscle Spasticity
- Being tested
- No Intervention
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There is no intervention administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI will be evaluated for spasticity by their healthcare provider. Patients diagnosed with spasticity requiring treatment will be enrolled in the study. There is no intervention administered in this study. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Assessment of Spasticity Severity using a 5-Point Scale
Measured: Day 1
Percentage of Participants with Spasticity not Receiving Treatment
Measured: Day 1
Spasticity Symptom Assessment Score using a 21-item Questionnaire
Measured: Day 1
Spasticity Impact Assessment Score using a 32-item Questionnaire
Measured: Day 1
Secondary outcomes (3)
Percentage of Participants with Spasticity Receiving Treatment
Measured: Day 1
Referral Patterns for Spasticity Management
Measured: Day 1
Spasticity Screening Tool Score using a 13-item Questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: Study suspended due to company decision prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145650
- Sponsor's protocol ID
- EPI-SPAS-001
- Acronym
- STRETCh
- Status last verified
- Nov 2015
- First submitted
- 21 May 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spasticity Registry Evaluating Epidemiology, Treatment Patterns and Clinical Needs
- ClinicalTrials.gov ID
- NCT02145650
- Acronym / sponsor ID
- STRETCh / EPI-SPAS-001
- Conditions
- Muscle Spasticity
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study suspended due to company decision prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 May 2014 (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.
This study will examine the epidemiology (incidence and control of a disease), burden, clinical need, and treatment patterns of spasticity in patients with a diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: No InterventionPatients with a diagnosis of CP, MS, Stroke, SCI, or TBI will be evaluated for spasticity by their healthcare provider. Patients diagnosed with spasticity requiring treatment will be enrolled in the study. There is no intervention administered in this study. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of CP, MS, Stroke, SCI, or TBI in clinical practice evaluated for spasticity.
Key inclusion criteria (1 listed)
- -Diagnosis of Cerebral Palsy (CP), Multiple Sclerosis (MS), Stroke, Spinal Cord Injury (SCI), or Traumatic Brain Injury (TBI) for a minimum of 3 months
Key exclusion criteria (1 listed)
- -Participation in a spasticity clinical trial in the past 5 years.
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 |
|---|---|---|
| No InterventionThere is no intervention administered in this study. | Other | All Participants |
Primary outcome
Investigator Assessment of Spasticity Severity using a 5-Point Scale
Time frame: Day 1
Percentage of Participants with Spasticity not Receiving Treatment
Time frame: Day 1
Spasticity Symptom Assessment Score using a 21-item Questionnaire
Time frame: Day 1
Spasticity Impact Assessment Score using a 32-item Questionnaire
Time frame: Day 1
3 secondary outcomes
Percentage of Participants with Spasticity Receiving Treatment
Time frame: Day 1
Referral Patterns for Spasticity Management
Time frame: Day 1
Spasticity Screening Tool Score using a 13-item Questionnaire
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Spasticity, run by Allergan at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 3 Nov 2015. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Investigator Assessment of Spasticity Severity using a 5-Point Scale (time frame: Day 1). The study lists 4 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 3 Nov 2015.