Parkinson's DiseasePhase 2NCT01351168
Use of Zolpidem in Parkinson's Disease
A Phase 2 study testing Levodopa, Zolpidem first dose and Zolpidem second dose in people with Parkinson's Disease, run by Rush University Medical Center at 1 site in United States.
Trial summary
Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Levodopa, Zolpidem first dose and Zolpidem second dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
- Subjects will be capable and willing to provide written informed consent prior to participation.
- Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
- Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
- All other PD medications are allowed.
- Subjects will be on a stable regimen of PD medications for 2 weeks prior to screening.
- Subjects will be required to come with a caregiver who can accompany the subject to/from each study visit. Note: Subjects will not be allowed to drive home.
- Female subjects will be advised to use adequate birth control throughout the study as the effects of ZLP on the fetus are unknown. Adequate birth control methods include surgical sterilization, a partner who has had a vasectomy, oral contraceptives, condom plus spermicidal cream/jelly, cervical cap plus spermicidal cream/jelly, diaphragm plus spermicidal cream/jelly, or intrauterine device (in place for at least 3 months) plus spermicidal cream/jelly. Abstinence is considered an acceptable contraceptive regimen. If a subject becomes pregnant during the study, it is important that they contact the study physician immediately.
Who cannot join
- Neurodegenerative diseases.
- Tremor predominant PD, with a score of > 2 in more than one body part.
- Inability to tolerate being off levodopa for 12 hours.
- A score on the Montreal Cognitive Assessment (MoCA) of less than 26.
- Pregnancy or lactation.
- History of drug or alcohol abuse.
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- Known or suspected sensitivity to the investigational study drugs.
- Other known medical or psychiatric condition that may compromise participation in the study or that judged by the site investigator could disqualify a subject from entering the study.
- Participation in another investigational drug study whereby they received experimental drug < 30 days prior to start of this study.
- Subjects who have undergone surgical procedures for PD but otherwise meet inclusion criteria will not be excluded a priori but evaluated on an individual basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: A Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism.
The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.
- Conditions
- Parkinson's Disease
- Being tested
- Levodopa, Zolpidem first dose, Zolpidem second dose, sugar pill
- Keywords
- Parkinson's disease, zolpidem
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevodopaDrug
Also called Sinemet
CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
Zolpidem first doseDrug
Also called Ambien
Zolpidem will be given at 10 mg on randomized testing day. The randomization is such that the first dose of Zolpidem given to any subject will always be 10 mg
Zolpidem second doseDrug
Also called Ambien
Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
sugar pillDrug
Also called Placebo
a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: sugar pill |
| Levodopa | Active comparator | Not described Receives: Drug: Levodopa |
| Zolpidam second dose | Experimental | Not described Receives: Drug: Zolpidem second dose |
| Zolpidam first dose | Experimental | Not described Receives: Drug: Zolpidem first dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS
Unified Parkinson's Disease Rating Scale
Measured: Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
Why it stopped: study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonard Verhagen Metman, Rush University Medical Center
- Investigators
- Leo Verhagen, MD PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351168
- Sponsor's protocol ID
- ZOL-PD
- Status last verified
- Nov 2012
- First submitted
- 9 May 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, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01351168
- Acronym / sponsor ID
- ZOL-PD
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, zolpidem
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- First posted
- 10 May 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.
Levodopa treatment is associated with long-term complications. Dopamine deficiency is associated with abnormal activity in certain parts of the brain. Zolpidem may change this abnormal activity and, by doing so, may work in a different way than levodopa to help parkinsonism.
The working hypothesis for this aim is that ZLP is superior to placebo in acutely improving motor symptoms of PD. The investigators will conduct a randomized,controlled, double-blind, cross-over study in 40 patients with PD. Each patient will receive placebo, levodopa and 2 doses of ZLP in a randomized order on 4 different occasions, about one week apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: sugar pill |
| Levodopa | Active comparator | Drug: Levodopa |
| Zolpidam second dose | Experimental | Drug: Zolpidem second dose |
| Zolpidam first dose | Experimental | Drug: Zolpidem first dose |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will have Idiopathic Parkinson's disease according to diagnostic criteria of the United Kingdom Parkinson's Disease Society Brain Bank.
- Subjects will be capable and willing to provide written informed consent prior to participation.
- Subjects will be ambulatory (in ON- and OFF-states) men and women, between the ages of 30 and 75 years.
- Subjects will be on levodopa therapy, with a good response and indisputable motor fluctuations.
- All other PD medications are allowed.
Key exclusion criteria (10 listed)
- Neurodegenerative diseases.
- Tremor predominant PD, with a score of > 2 in more than one body part.
- Inability to tolerate being off levodopa for 12 hours.
- A score on the Montreal Cognitive Assessment (MoCA) of less than 26.
- Pregnancy or lactation.
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 |
|---|---|---|
| LevodopaAlso: SinemetCD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day | Drug | Levodopa |
| Zolpidem first doseAlso: AmbienZolpidem will be given at 10 mg on randomized testing day. The randomization is such that the first dose of Zolpidem given to any subject will always be 10 mg | Drug | Zolpidam first dose |
| Zolpidem second doseAlso: AmbienZolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose. | Drug | Zolpidam second dose |
| sugar pillAlso: Placeboa sugar pill (placebo) will all be given orally in identical capsules to the other study drugs | Drug | Sugar pill |
Primary outcome
UPDRS
Time frame: Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.
Unified Parkinson's Disease Rating Scale
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 Dec 2012.
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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.
Leo Verhagen, MD PhD principal investigator
Rush University Medical Center
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 Levodopa, Zolpidem first dose and Zolpidem second dose in people with Parkinson's Disease, run by Rush University Medical Center 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 8 inclusion and 10 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 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 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. 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 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?
UPDRS (time frame: Subjects rated using the UPDRS at the Screening visit and then at each of the 4 study visits (1-2 weeks apart). During the study visits subjects will be rated every 30 minutes until they return to baseline.). 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.