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Parkinson's Disease (PD)Phase 3DYSCOVERNCT02799381

A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)

A Phase 3 study testing Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG) and CADD-Legacy ambulatory infusion pump in people with Parkinson's Disease (PD), run by AbbVie at 28 sites in 7 countries.

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 was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson's Disease (PD)
What is being tested?
Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG) and CADD-Legacy ambulatory infusion pump
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
28 sitesin 7 countries
Study dates
9 Feb 2017to 19 Sep 2019
Phase
Phase 3
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

  • Participants must have a diagnosis of idiopathic Parkinson's disease (PD) according to the United Kingdom Parkinson's Disease Society (UKPDS) Brain Bank Criteria
  • Participants with advanced levodopa-responsive PD and persistent motor fluctuations who have not been controlled with optimized medical treatment (OMT: the maximum therapeutic effect obtained with pharmacological antiparkinsonian therapies when no further improvement is expected with regard to any additional manipulations of levodopa and/or other antiparkinsonian medication based on the Investigator's clinical judgment)
  • Unified Dyskinesia Rating Scale (UDysRs) Total score ≥ 30 at Visit 3

Who cannot join

  • Participant(s) treated with levodopa-carbidopa intestinal gel (LCIG) previously
  • Participant's PD diagnosis is unclear or there is a suspicion that the subject has a parkinsonian syndrome such as secondary parkinsonism (e.g. caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), parkinson-plus syndrome (e.g. Multiple System Atrophy, Progressive supranuclear Palsy, Diffuse Lewy Body disease) or other neurodegenerative disease that might mimic the symptoms of PD
  • Participant(s) has undergone neurosurgery for the treatment of Parkinson's disease.
  • Participant(s) has contraindications to levodopa (e.g. narrow angle glaucoma, malignant melanoma)
  • Participant(s) experiencing clinically significant sleep attacks or clinically significant impulsive behavior (e.g. pathological gambling, hypersexuality) at any point during the three months prior to the Screening evaluation as judged by the Principal Investigator

Trial locations and contacts

28 sites in 7 countries.

28 sites in 7 countries

Spain9 sites

  • Hospital Universitario Cruces /ID# 203807

    Barakaldo, 48903

  • Hospital General Univ de Elche /ID# 150154

    Elche, 03202

  • Hospital Univ de la Princesa /ID# 150157

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon /ID# 150155

    Madrid, 28007

  • Hospital Univ Ramon y Cajal /ID# 150152

    Madrid, 28034

  • Hospital Universitario Infanta /ID# 159696

    Madrid, 28702

  • Hospital Regional Universitari /ID# 171485

    Málaga, Malaga, 29010

  • Hospital Universitario Virgen Macarena /ID# 158861

    Seville, 41009

  • Hospital Virgen de la Salud /ID# 166297

    Toledo, 45005

Other trials in Spain

Italy5 sites

  • A.O. Univ. Ospedali Riuniti /ID# 150853

    Ancona, The Marches, 60126

  • Azienda USL Toscana Centro /ID# 150770

    Florence, 50012

  • Seconda Universita' di Napoli /ID# 150851

    Naples, 80138

  • Policlinico Universitario Campus Bio-Medico /ID# 150846

    Rome, Lazio, 00128

  • Policlinico Tor Vergata /ID# 151167

    Rome, 00133

Other trials in Italy

Slovakia4 sites

  • Univerzitna Nemocnica Bratislava /ID# 150144

    Bratislava, 821 01

  • Univerzitna Nemocnica Bratislava /ID# 150171

    Bratislava, 821 01

  • Univerzitna nemocnica L. Pasteura /ID# 150146

    Košice - Západ, Košice Region, 041 66

  • Univerzitna nemocnica Martin /ID# 150145

    Martin, Žilina Region, 036 01

Other trials in Slovakia

Greece3 sites

  • Mediterraneo Hospital /ID# 150955

    Glyfada, 16675

  • University General Hospital of Heraklion "PA.G.N.I" /ID# 150956

    Heraklion, 71110

  • University Hospital of Ioannin /ID# 150954

    Ioannina, 45500

Other trials in Greece

Hungary3 sites

  • Semmelweis Egyetem /ID# 170117

    Budapest, 1085

  • Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 170116

    Pécs, Pecs, 7624

  • Szegedi Tudomanyegyetem /ID# 170115

    Szeged, 6720

Other trials in Hungary

United States2 sites

  • Parkinson's Disease Treatment Center of Southwest Florida /ID# 150095

    Port Charlotte, Florida, 33980

  • Central Texas Neurology Consul /ID# 150088

    Round Rock, Texas, 78681

Other trials in United States

Finland2 sites

  • Helsinki Univ Central Hospital /ID# 151214

    Helsinki, 00290

  • Oulun yliopistollinen sairaala /ID# 150947

    Oulu, 90220

Other trials in Finland

About this study

Official title: An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)

The primary objective of this study was to examine the effect of levodopa-carbidopa intestinal gel (LCIG) compared with optimized medical treatment (OMT) on dyskinesia in participants with advanced Parkinson's disease (PD).

Read the detailed description

This was a Phase 3b, open-label, randomized, multicenter, 12-week study. The study consisted of 3 sequential periods: Screening, Treatment, and Follow-Up. The OMT group had the same schedule of visits/procedures throughout the study as the LCIG treatment group, except for visits related to nasojejunal (NJ)/percutaneous endoscopic gastrostomy (PEG) procedures, titration of LCIG, and follow-up period.

Being tested
Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG), CADD-Legacy ambulatory infusion pump, Percutaneous endoscopic gastrostomy tube, Jejunal extension tube
Keywords
Carbidopa, Levodopa, Efficacy, Levodopa-carbidopa intestinal gel, Advanced Parkinson's Disease
Medical subject headings
Parkinson Disease

What participants receive

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

  • Optimized antiparkinsonian treatmentDrug

    Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.

  • Levodopa-Carbidopa Intestinal Gel (LCIG)Drug

    Also called ABT-SLV187, DUOPA (carbidopa and levodopa Enteral Suspension), DUODOPA

    Dose levels were individually optimized.

  • CADD-Legacy ambulatory infusion pumpDevice

    (manufactured by Smiths Medical)

  • Percutaneous endoscopic gastrostomy tubeDevice

    (PEG tube)

  • Jejunal extension tubeDevice

    (J-tube)

Study groups in NCT02799381
Study groupRoleWhat they receive
Optimized Medical Treatment (OMT)Active comparatorParticipants randomized to OMT continued their current anti Parkinson's disease (anti-PD) medication regimen for the duration of the study. All anti-PD medications and medications to treat dyskinesia must have remained stable for the duration of the study unless adjustments were medically indicated. The Investigator provided the prescription for continued OMT.
Receives: Drug: Optimized antiparkinsonian treatment
Levodopa-Carbidopa Intestinal Gel (LCIG)ExperimentalThe total daily dose of infusion LCIG was composed of three components: (i) the morning dose, (ii) continuous maintenance infusion dose and (iii) extra doses. A temporary nasojejunal (NJ) tube may have been used initially with the infusion pump to determine a participant's response to this method of treatment and to optimize the dose of LCIG before treatment with a permanent percutaneous endoscopic gastrostomy - with jejunal extension (PEG-J) tube was started. Following optional NJ and/or PEG-J placement and, at the investigator's discretion, the participant may have begun initiation and titration of LCIG infusion on Day 1 once tube placement was confirmed. The dose of LCIG was adjusted to obtain the optimal clinical response. The rate of LCIG infusion is typically within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances and runs over a period of 16 consecutive hours each day.
Receives: Drug: Levodopa-Carbidopa Intestinal Gel (LCIG); Device: CADD-Legacy ambulatory infusion pump; Device: Percutaneous endoscopic gastrostomy tube; Device: Jejunal extension tube

What is being measured

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

  1. Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score

    The Unified Dyskinesia Rating Scale (UDysRS) is a tool used to assess dyskinesia in Parkinson's disease (PD) and contains both self-evaluation questions and items that are assessed directly by the physician to objectively rate the abnormal movements associated with PD. Part 1 contains 11 questions about the ON time dyskinesia and the impact of ON-dyskinesia on experiences of daily living. Part 2 contains 4 questions about OFF-dystonia rating. Part 3 contains 7 questions about objective evaluation of dyskinesia impairment and Part 4 contains 4 questions regarding dyskinesia disability. Each question is scored with respect to severity, which is rated on a scale where 0 = normal, 1 = slight, 2 = mild, 3= moderate and 4 = severe. The UDysRS total score is obtained by summing the item scores, ranging from 0 to 104. Higher scores are associated with more disability. Negative changes from baseline indicate improvement.

    Measured: Baseline, Week 12

Secondary outcomes (6)

  1. Mean Change From Baseline to Week 12 in ON Time Without Troublesome Dyskinesia

    The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Positive change from baseline for ON time without troublesome dyskinesia indicates improvement.

    Measured: Baseline, Week 12

  2. Mean Change From Baseline to Week 12 in Parkinson's Disease Questionnaire-8 (PDQ-8) Summary Index

    The Parkinson's Disease Questionnaire-8 (PDQ-8) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires. The PDQ-8 is a self-administered questionnaire. Each item is scored on the following 5-point scale: 0 = Never, 1 = Occasionally, 2 = Sometimes, 3 = Often, 4 = Always (or cannot do at all, if applicable). Higher scores are consistently associated with the more severe symptoms of the disease such as tremors and stiffness. The results are presented as a summary index. The PDQ-8 summary index ranges from 0 to 100, where lower scores indicate a better perceived health status. Negative changes from baseline indicate improvement.

    Measured: Baseline, Week 12

  3. Mean Clinical Global Impression of Change (CGI-C) Score at Week 12

    The Clinical Global Impression of Change (CGI-C) score is a clinician's rating scale for assessing Global Improvement of Change. The CGI-C rates improvement by 7 categories: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), very much worse (7). The CGI-C score ranges from 1 to 7, with lower scores indicating improvement.

    Measured: Baseline, Week 12

  4. Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score (Activities of Daily Living)

    The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions related to Activities of Daily Living, and ranges from 0-52. Higher scores are associated with more disability. Negative values indicate improvement from baseline.

    Measured: Baseline, Week 12

  5. Mean Change From Baseline to Week 12 in OFF Time

    The Parkinson's Disease (PD) Symptom Diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected study visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e., 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. ON time is when PD symptoms are well controlled by the drug, and OFF time is when PD symptoms are not adequately controlled by the drug. Negative change from baseline for OFF time indicates improvement.

    Measured: Baseline, Week 12

  6. Mean Change From Baseline to Week 12 in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score (Motor Examination)

    The Unified Parkinson's Disease Rating Scale (UPDRS) is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers related to Motor Examination, and ranges from 0-108. Higher scores are associated with more disability. Negative values indicate improvement from baseline.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted14 Jun 2016 (estimated)
  2. Study start9 Feb 2017
  3. Primary completion19 Sep 2019
  4. Study completion19 Sep 2019

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02799381
Sponsor's protocol ID
M15-535
Other IDs
2016-001403-23, 2016
Acronym
DYSCOVER
Status last verified
Aug 2020
First submitted
10 Jun 2016
Last updated
18 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Freire-Alvarez E, Vanni P, Kurca E, Lopez-Manzanares L, Kovacs N, Spanaki C, Gao T, Bergmann L, Sanchez-Solino O. Dyskinesia and Pain in Advanced Parkinson's Disease: Post Hoc Analysis from the Phase 3b, Open-Label, Randomized DYSCOVER Study. Neurol Ther. 2024 Apr;13(2):437-447. doi: 10.1007/s40120-024-00583-z. Epub 2024 Feb 12.

    PubMed 38345741

  • Freire-Alvarez E, Kurca E, Lopez Manzanares L, Pekkonen E, Spanaki C, Vanni P, Liu Y, Sanchez-Solino O, Barbato LM. Levodopa-Carbidopa Intestinal Gel Reduces Dyskinesia in Parkinson's Disease in a Randomized Trial. Mov Disord. 2021 Nov;36(11):2615-2623. doi: 10.1002/mds.28703. Epub 2021 Jul 8.

    PubMed 34236101

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Optimized antiparkinsonian treatment, Levodopa-Carbidopa Intestinal Gel (LCIG) and CADD-Legacy ambulatory infusion pump in people with Parkinson's Disease (PD), run by AbbVie at 28 sites in 7 countries.

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 3 inclusion and 5 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Spain, Italy, Slovakia, Greece, Hungary and 2 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Aug 2020). 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?

Mean Change From Baseline to Week 12 in Unified Dyskinesia Rating Scale (UDysRS) Total Score (time frame: Baseline, Week 12). 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 NCT02799381, which also lists 2 linked publications.

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 18 Aug 2020.

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