Parkinson's DiseasePhase 2NCT01515410

Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations

A Phase 2 study testing DM-1992 and Sinemet IR in people with Parkinson's Disease and Motor Fluctuations, run by Depomed at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by: "ON" time with no dyskinesia or non-troublesome dyskinesia "OFF" time Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Parkinson's Disease, Motor Fluctuations
What is being tested?: DM-1992 and Sinemet IR
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 7 sitesUnited States
Study dates: Jan 2012to Oct 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Who cannot join

Patients with atypical or drug-induced Parkinson's disease.
Patients with a known history of hypersensitivity to levodopa or carbidopa.
Patients who receive treatments with dopamine receptor blocking agents
Patients with a history of seizures except of childhood febrile seizure.
Patients with dementia.
Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.

Show all 13Show fewer

Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
Patients with an immune-compromised state.
Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
Patients who have a difficulty swallowing tablets.
Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Study site
Bingham Farms, Michigan
Study site
Birmingham, Alabama
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Dallas, Texas
Study site
Little Rock, Arkansas
Study site
Long Beach, California

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations

The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:

"ON" time with no dyskinesia or non-troublesome dyskinesia
"OFF" time

Conditions: Parkinson's Disease, Motor Fluctuations
Being tested: DM-1992, Sinemet IR
Keywords: Parkinson's disease, PD, stage2/3Parkinson's, Advanced Parkinson's Disease with Motor Fluctuations
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DM-1992Drug
72.5mg carbidopa/230mg levodopa
Sinemet IRDrug
Immediate-release tablet containing 25mg carbidopa and 100mg levodopa

Study groups in NCT01515410
Study group	Role	What they receive
DM-1992	Experimental	DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) Receives: Drug: DM-1992
Sinemet IR	Active comparator	An Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) Receives: Drug: Sinemet IR

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100.
Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state.
Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1.
End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period.
Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.
Measured: Baseline and 10 days for each of the 2 study periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Oct 2012

First posted24 Jan 2012 (estimated)
Study startJan 2012
Primary completionSep 2012
Study completionOct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies 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: Crossover
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01515410
Sponsor's protocol ID: 81-0068
Status last verified: Nov 2012
First submitted: 11 Jan 2012
Last updated: 10 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor Fluctuations
ClinicalTrials.gov ID: NCT01515410
Acronym / sponsor ID: 81-0068
Conditions: Parkinson's Disease, Motor Fluctuations
Keywords: Parkinson's disease, PD, stage2/3Parkinson's, Advanced Parkinson's Disease with Motor Fluctuations
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: DepomedIndustry (pharma, biotech, devices)
Study start: Jan 2012
Primary completion: Sep 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 24 Jan 2012 (estimated)
Results: Posted 10 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to explore the efficacy and tolerability of DM-1992 compared to a standard carbidopa/Levodopa Immediate-Release (CD/LD IR) tablet (Sinemet IR) as measured by:

"ON" time with no dyskinesia or non-troublesome dyskinesia
"OFF" time

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DM-1992	Experimental	Drug: DM-1992DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
Sinemet IR	Active comparator	Drug: Sinemet IRAn Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when "on."
Patients should be able to differentiate between the "ON" and "OFF" states with an average daily "OFF" time of ≥ 2.5 hours at study entry.
On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).

Key exclusion criteria (13 listed)

Patients with atypical or drug-induced Parkinson's disease.
Patients with a known history of hypersensitivity to levodopa or carbidopa.
Patients who receive treatments with dopamine receptor blocking agents
Patients with a history of seizures except of childhood febrile seizure.
Patients with dementia.

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
DM-199272.5mg carbidopa/230mg levodopa	Drug	DM-1992
Sinemet IRImmediate-release tablet containing 25mg carbidopa and 100mg levodopa	Drug	Sinemet IR

Primary outcome

The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.
Time frame: Baseline and 10 days for each of the 2 study periods
"OFF" indicates wearing off motor fluctuations before the next levodopa dose. Percent "OFF" time is calculated as the total "OFF" time divided by the total awake time for each day and multiplied by 100. Patient diary-every 30min while awake for 3days prior to initial Day1 as baseline \& during the last 3days before Day10 for both treatments for dyskinesia state. Baseline is the average of the 3 days recorded in the patient diary prior to Day 1 of Period 1. End of Period is the average of the 3 days recorded in the patient diary prior to Day 10 in each period. Clinician-Assess efficacy at pre-dose, every 30min for Day1 and hourly for Day10 for dyskinesia state \& motor fluctuations at clinic visits.

Results and safety

Results posted to the registry on 10 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DM-1992 First, Then Sinemet IR	19	19
Sinemet IR First, Then DM-1992	15	15

Primary outcome: The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time.

Time frame: Baseline and 10 days for each of the 2 study periods. Least squares mean (95% Confidence Interval). Unit: percentage of time

Measure	DM-1992 n = 34	Sinemet IR n = 34
Value	-5.52 (-10.42 to -0.63)	1.33 (-3.56 to 6.22)

DM-1992 vs Sinemet IR: Difference in Least Squares Mean: -6.86 (95% CI -13.62 to -0.09), p = 0.0471, ANCOVA

Population analysed: Modified Intent-to-treat (ITT) Population

Adverse events

Time frame: Adverse events collected for a total of 5-6 weeks: from after signing the informed consent to the end of the study (Period 2, Day 10).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DM-1992	0 of 34 (0%)	12 of 34 (35.3%)	Not reported
Sinemet IR	0 of 34 (0%)	4 of 34 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
RecruitingPhase 1/2
Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease
Parkinson's Disease
Active, not recruiting
MR-guided Focused Ultrasound Plus GCase
Parkinsons Disease
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Not yet recruitingPhase 1
Stanford University Neurofiber Study
PARKINSON DISEASE (Disorder)

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.

Rekha Sathyanarayana study director

Depomed

7 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 DM-1992 and Sinemet IR in people with Parkinson's Disease and Motor Fluctuations, run by Depomed at 7 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 13 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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.

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?

Yes. Results are posted in the registry (first posted 10 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Primary Objective of This Study is to Explore the Efficacy and Tolerability of DM-1992 Compared to a Standard CD/LD IR Formulation as Measured by Percent "OFF" Time. (time frame: Baseline and 10 days for each of the 2 study periods). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01515410.

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 10 Mar 2014.