Conditions for Which There is a Documented Medical Necessity to Receive Treatment With RotigotineNCT01095484
Named Patient Program With Rotigotine Transdermal System
An observational study of Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine, run by UCB Pharma at 51 sites in United States.
Trial summary
The named patient program will allow investigators to supply rotigotine transdermal system to patients who have a documented medical necessity to receive treatment with the drug. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
- What is being tested?
- Rotigotine patch
- How many people
- 520 participants
- Where
- 51 sitesUnited States
- Study dates
- Nov 2008to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
Who may be able to join
- Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- Subject is willing and able to comply with all trial requirements
- Subject either:
- is currently taking no more than 3 mg/24 h Rotigotine for Idiopathic Restless Legs Syndrome (RLS) in adults, 6 mg/24 h Rotigotine for early-stage Parkinson's disease, 8 mg/24 h Rotigotine for advanced stage Parkinson's disease (ie, treated with concomitant l-dopa) and has tried and failed an adequate course of another dopamine agonist, with failure defined as either suboptimal control of symptoms or the development of intolerable Adverse Events (AEs) (eg, hallucinations), or
- is not taking Rotigotine but has previously demonstrated an adequate response following an appropriate course of treatment with another dopamine agonist or l-dopa, based on the investigator's assessment and has tried and failed an adequate course of another dopamine agonist, or
- has completed participation in UCB Rotigotine clinical trial SP0934, SP1055, or RL0003
- The investigator attests to the medical necessity of treatment with Rotigotine in contrast to alternate treatments (eg, dysphagia).
- The investigator receives written approval from the Sponsor to enroll the subject
Who cannot join
- Subject is pregnant or nursing or is of child bearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods or (iii) not sexually abstinent or (iv) subject is not at least 2 years postmenopausal
- Subject has any other clinically significant medical condition, psychiatric condition, or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the trial
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
018
Albany, New York
065
Albany, Oregon
030
Atlanta, Georgia
070
Atlantis, Florida
048
Austin, Texas
072
Austin, Texas
036
Berkeley, California
088
Birmingham, Alabama
002
Boca Raton, Florida
066
Brooklyn, New York
052
Charlotte, North Carolina
031
Clearwater, Florida
091
Clinton Township, Michigan
082
Cullman, Alabama
071
Dallas, Texas
025
Destrehan, Louisiana
085
Fairhope, Alabama
035
Fort Collins, Colorado
024
Fountain Valley, California
086
Freehold, New Jersey
097
Gilbert, Arizona
041
Honolulu, Hawaii
046
Houston, Texas
014
Huntsville, Alabama
034
Irvine, California
005
Kirkland, Washington
028
Largo, Florida
026
Lincoln, Nebraska
019
Los Angeles, California
056
Milwaukee, Wisconsin
037
Ocean Springs, Mississippi
017
Olympia, Washington
040
Orange, California
075
Ormond Beach, Florida
006
Patchogue, New York
011
Peoria, Illinois
003
Phoenix, Arizona
044
Phoenix, Arizona
062
Ridgewood, New Jersey
009
Salem, Oregon
093
Salisbury, North Carolina
001
Southfield, Michigan
012
Spokane, Washington
022
St. Petersburg, Florida
076
Sunnyvale, California
053
Tacoma, Washington
004
Tampa, Florida
042
Warren, Michigan
027
Washington D.C., District of Columbia
016
West Plains, Missouri
054
Weston, Florida
About this study
The named patient program will allow investigators to supply rotigotine transdermal system to patients who have a documented medical necessity to receive treatment with the drug.
- Conditions
- Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
- Being tested
- Rotigotine patch
- Keywords
- Rotigotine, Neupro®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotigotine patchDrug
Also called Neupro patch
1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice. Receives: Drug: Rotigotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
Measured: From Baseline to End of Study (up to 48 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conditions for Which There is a Documented Medical Necessity to Receive Treatment With RotigotineStudies 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
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095484
- Sponsor's protocol ID
- SP0953
- Status last verified
- Dec 2012
- First submitted
- 26 Mar 2010
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Named Patient Program With Rotigotine Transdermal System
- ClinicalTrials.gov ID
- NCT01095484
- Acronym / sponsor ID
- SP0953
- Conditions
- Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine
- Keywords
- Rotigotine, Neupro®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 520 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Mar 2010 (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 named patient program will allow investigators to supply rotigotine transdermal system to patients who have a documented medical necessity to receive treatment with the drug.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | – | Drug: Rotigotine patchPatients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a documented medical necessity to receive treatment with rotigotine treatment in accordance with standard medical practice.
Key inclusion criteria (8 listed)
- Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
- Subject is willing and able to comply with all trial requirements
- Subject either:
- The investigator attests to the medical necessity of treatment with Rotigotine in contrast to alternate treatments (eg, dysphagia).
- The investigator receives written approval from the Sponsor to enroll the subject
Key exclusion criteria (3 listed)
- Subject is pregnant or nursing or is of child bearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods or (iii) not sexually abstinent or (iv) subject is not at least 2 years postmenopausal
- Subject has any other clinically significant medical condition, psychiatric condition, or laboratory abnormality that would, in the judgment of the investigator, interfere with the subject's ability to participate in the trial
- Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C SSRS) at Screening
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 |
|---|---|---|
| Rotigotine patchAlso: Neupro patch1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment | Drug | Rotigotine |
Primary outcome
Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
Time frame: From Baseline to End of Study (up to 48 months)
Adverse events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months)
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 20 Oct 2014.
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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conditions for Which There is a Documented Medical Necessity to Receive Treatment With Rotigotine, run by UCB Pharma at 51 sites 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 8 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites 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 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?
Adverse Events as reported spontaneously by the subject or as assessed by the investigator at the maintenance visits (about every three months) (time frame: From Baseline to End of Study (up to 48 months)). 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 20 Oct 2014.