Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:16 AM
Study NCT ID:
NCT07432958
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-01-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in average daily OFF time on motor diaries for AP-472 compared to placebo (normalized to 16-hour awake time)', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in ON time without troublesome dyskinesia (normalized to 16 hours)', 'timeFrame': 'Week 12'}, {'measure': "Change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 2 (Motor Experiences of Daily Living (M-EDL)) score", 'timeFrame': 'Week 12', 'description': 'For MDS-UPDRS Part II (Motor Experiences of Daily Living, M-EDL) there are 13 items each scored from 0 to 4. The total score range is from 0-52. A higher score indicates worse motor impact on daily activities; lower scores are better.'}, {'measure': "Change from baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index", 'timeFrame': 'Week 12', 'description': "For the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index the score is calculated by averaging the 8 domain scores and converting them to a 0-100 scale. A higher score indicates worse health-related quality of life; lower scores are better."}, {'measure': 'Change from baseline in MDS-UPDRS Part III (Motor Examination) score in the best ON state', 'timeFrame': 'Week 12', 'description': 'The MDS-UPDRS Part III includes 33 items, each scored from 0 to 4. The total score range is from 0-132. A higher score indicates worse motor impairment; lower scores are better.'}, {'measure': 'Change from baseline in Epworth Sleepiness Scale (ESS) total score', 'timeFrame': 'Week 12', 'description': 'The ESS consists of 8 items, each scored from 0 to 3. The total score range is from 0-24. Higher scores indicate greater daytime sleepiness; lower scores are better.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Parkinson Disease', 'Motor Fluctuations', 'OFF Time', 'Wearing-Off', 'Dyskinesia', 'AP-472', 'Adjunctive Therapy', 'Levodopa Adjunct', 'Positive Allosteric Modulator', 'Metabotropic Glutamate Receptor 4'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "This is a Phase 2 study in people with Parkinson's disease who experience motor fluctuations while taking levodopa. The study will evaluate how effective two different doses of the study drug AP-472 are when added to levodopa treatment, compared with a placebo.\n\nThe study will last about 12 weeks. Participants will be randomly assigned to receive one of the two doses of AP-472 or a placebo. Neither the participants nor the study staff will know which treatment is given.\n\nThe study includes a screening period, a 4-week period during which Parkinson's medications must remain stable, and an 8-week treatment period. During the treatment period, limited adjustments to levodopa are allowed if needed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nParticipants must meet all of the following criteria to take part in the study:\n\n1. Be a man or woman between 30 and 80 years of age at the time of screening.\n2. Have a diagnosis of Parkinson\'s disease, confirmed using standard medical criteria, including slowness of movement and symptoms that affect one side of the body more than the other.\n3. Have mild to moderate Parkinson\'s disease, defined as stage 3 or lower on the Hoehn and Yahr scale when medications are working ("ON" state).\n4. Experience an average of at least 3 hours of OFF time per day, based on home symptom diaries, with at least 2.5 hours of OFF time each day during the baseline period.\n5. Have a Montreal Cognitive Assessment (MoCA) score of 24 or higher at screening.\n6. Be able to walk independently, with or without the use of a walking aid.\n7. Be able to swallow oral medication.\n8. Have been on a stable Parkinson\'s medication regimen for at least 4 weeks before screening. Medications known as MAO-B inhibitors must have been stable for at least 12 weeks.\n9. Be taking levodopa at least four times daily (immediate- or controlled-release formulations) or three times daily (extended-release formulations such as Rytary or Crexont).\n\nKey Exclusion Criteria:\n\nParticipants cannot take part in the study if any of the following apply:\n\n1. Have a form of parkinsonism that is not typical Parkinson\'s disease, such as secondary or atypical parkinsonism.\n2. Have previously received, or plan to receive during the study, advanced Parkinson\'s therapies such as continuous levodopa or dopamine delivery systems, or Parkinson\'s disease-related brain surgery.\n3. Have dyskinesias (involuntary movements) that are severe enough, in the study doctor\'s opinion, to interfere with participation.\n4. Have a history of only certain types of dyskinesias (such as OFF-state, diphasic, myoclonic, or dystonic dyskinesias) without typical peak-dose dyskinesias.\n5. Are currently taking medications that block dopamine, except for low-dose quetiapine (up to 50 mg per day) used for insomnia.\n6. Routinely use on-demand "rescue" Parkinson\'s medications more than three times per week.'}, 'identificationModule': {'nctId': 'NCT07432958', 'briefTitle': "A Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations", 'organization': {'class': 'INDUSTRY', 'fullName': 'Appello Pharmaceuticals, Inc.'}, 'officialTitle': "Phase 2, Double-blind, Placebo-controlled Study to Evaluate the Effectiveness of Two Doses of AP-472 as Adjunctive Therapy to Levodopa in Parkinson's Disease (PD) Participants With Motor Fluctuations", 'orgStudyIdInfo': {'id': 'APLO-1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': 'AP-472 100 mg per day', 'interventionNames': ['Drug: AP-472', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'AP-472 300 mg per day', 'interventionNames': ['Drug: AP-472']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'AP-472', 'type': 'DRUG', 'description': 'Oral tablet', 'armGroupLabels': ['High Dose', 'Low Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oral tablet', 'armGroupLabels': ['Low Dose', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205-5551', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90720-3108', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'Collaborative Neuroscience Network - Los Alamitos- CenExel - PPDS', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90033-5310', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Medicine of USC - USC Healthcare Center 2', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92056-4454', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'North County Neurology Associates', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '94301', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Parkinson's Research Centers of America", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80113-2776', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Clinical Research - CenExel - PPDS', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '33136-1051', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology One', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33613-4808', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "USF Parkinson's Disease and Movement Disorders Center", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912-0020', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Medical Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '66103-2078', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'The University of Kansas (KU)', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40536-0001', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentucky Neuroscience Institute', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02215-5400', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System (UMHS)', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48334-2973', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Quest Research Institute - Alcanza - PPDS', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10029-6501', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Joan and Sanford I. Weill Department of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Neurological Disorders Clinic', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195-0001', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43202-4500', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '74136-7027', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Movement Disorder Clinic of Oklahoma PLLC', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78681-3578', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Neurology Consultants', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '98034-3013', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'facility': 'EvergreenHealth', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}], 'centralContacts': [{'name': 'Annie Blobaum, Ph.D.', 'role': 'CONTACT', 'email': 'annie@appellopharma.com', 'phone': 'Please email:'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Appello Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}