Today, we will be looking into the latest research and clinical trials focused on Parkinson's disease in adults.
The following list has been carefully curated by evaluating the ongoing Phase 3 trials for Parkinson's disease, specifically targeting adults in the United States. Please note that the dates provided are approximate and subject to change. This compilation primarily features studies that have released updates within the past 12 months.
This series aims to offer a glimpse into upcoming innovations in the field and how the outcomes of these studies could potentially influence clinical guidelines related to the topic.
Without further ado, let us explore the list of Parkinson's Disease Clinical Trials!
Quick View Table of Parkinson's Disease Clinical Trials
Phase 3 Clinical Trials:
Open-label Trial in Parkinson's Disease (PD) (TEMPO-4)
- Sponsor: AbbVie
- The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.
- Interventions:
- Drug: Tavapadon
- Primary Outcome Measures:
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, Vital Signs, Physical and Neurological evaluations and ECGs will be reported as TEAEs.
- Time frame - 62 Weeks
- Number of Participants Who Discontinued Study Treatment
- A participant may discontinue the study treatment due to any of the following reasons: adverse event, death, worsening of PD symptoms to such an extent that, in the judgement of the investigator, the participant requires additional anti-PD medications, treatment with a prohibited concomitant medication, noncompliance with the trial schedule or procedures, withdrawal of consent, pregnancy, investigator discretion.
- Time frame - 62 Weeks
- Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease Rating Scale (QUIP-RS)
- QUIP-RS is a global screening instrument that assesses impulse control disorders (ICDs) and related disorders (punding, hobbyism, and dopamine dysregulation syndrome) in participants with PD. The QUIP-RS has 4 primary questions that pertain to commonly reported thoughts, urges/desires, and behaviors associated with ICDs, each of which is applied to 4 ICDs (compulsive gambling, buying, eating, sexual behavior) and 3 related disorders (medication use, punding, and hobbyism). The QUIP-RS uses a 5-point Likert scale (score 0-4 [0 means "never" and 4 means "very often"] for each question) to gauge the frequency of behaviors. Scores for each ICD and related disorder range from 0 to 16, with a higher score indicating greater severity (frequency) of symptoms. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.
- Time frame - 58 Weeks
- Epworth Sleepiness Scale (ESS)
- ESS is a scale that is intended to measure daytime sleepiness. It assesses the likelihood of dozing off or falling asleep in the following common situations: sitting and reading, sitting inactive in a public place as a passenger in a car for an hour or more without stopping for a break, lying down to rest when circumstances permit, sitting and talking to someone, sitting quietly after a meal without alcohol, and in a car while stopped for a few minutes in traffic or at a light. Each situation is rated as 0 = would never nod off, 1 = slight chance of nodding off, 2 = moderate chance of nodding off, or 3 = high chance of nodding off. A score greater than or equal to (> =) 10 indicates that the participant may need to get more sleep, improve sleep practices, or seek medical attention to determine why he or she is sleepy.
- Time frame - 58 Weeks
- Columbia-Suicide Severity Rating Scale (C-SSRS)
- C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
- Time frame - 60 Weeks
- Study Medication Withdrawal Questionnaire (SMWQ)
- SMWQ is a questionnaire to assess withdrawal symptoms subsequent to completion of dosing with Investigational medicinal product (IMP). The SMWQ is a modification of the Amphetamine Withdrawal Questionnaire, in which the first question "Have you been craving amphetamine or methamphetamine?" is replaced with "Have you been craving the trial medication?" This change is intended to prevent bias by implying that the trial medication might be an amphetamine or amphetamine-like stimulant when presented with the survey. Participants will complete the SMWQ onsite when they are at a designated trial visit; on days when the participant is not onsite, they will complete the SMWQ remotely.
- Time frame - 60 Weeks
- Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II and III
- The MDS-UPDRS is a multidimensional scale that assesses the motor and non-motor impacts of PD across 4 parts. Part I, non-motor aspects of experiences of daily living, comprises 13 items, 6 of which are rated by the physician (Part IA) and 7 of which are rated by the participant (Part IB). Part II, motor aspects of experiences of daily living, comprises 13 items that are rated by the participant. Part III, motor examination, comprises 18 items that are assessed by the investigator (resulting in 33 scores by location and lateralization). Part IV, motor complications, comprises 6 item (3 items for dyskinesia and 3 items for fluctuation) and requires the physician to use historical and objective information to assess dyskinesia and motor fluctuations. Each item of all the parts will be rated on a scale from 0 to 4 on which 0 = normal, 1=slight, 2=mild, 3=moderate, and 4=severe. Change from baseline in MDS-UPDRS parts I, II and III combined score will be assessed.
- Time frame - 60 Weeks
- Change From Baseline in the Hauser diary
- The Hauser diary (Hauser et al, 2000) assesses participant-defined clinical status over a period of time and provides a tool for assessment of the change in "off" time and "on" time with troublesome dyskinesia (which is a more accurate reflection of clinical response than "off" time alone). The Hauser diary asks participants to rate their mobility for each 30-minute period and to record their status for the majority of the period in 1 of 5 categories as: "on" time without dyskinesia, "on" time with nontroublesome dyskinesia, "on" time with troublesome dyskinesia, "off" time, or asleep.
- Time frame - 58 Weeks
- Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L)
- Index EQ-5D-5L is a survey instrument used for participant-reported outcome that measures health in 5 dimensions. The EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels of perceived problems (1 = no problem, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = extreme problems). Participant selects an answer for each of 5 dimensions considering the response that best matches his/her health "today". The digits for the 5 dimensions are combined into a 5-digit number that describes the participant's health state.
- Time frame - Baseline (Day 1), Weeks 32 and 58
- Change From Baseline in the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scores (VAS) EQ-5D-5L
- VAS is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine).
- Time frame - Baseline (Day 1), Weeks 32 and 58
Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease
- Sponsor:AbbVie
- Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia.
- Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.
- There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.
- Interventions:
- Drug: ABBV-951
- Primary Outcome Measures:
- Percentage of Participants with Adverse Event (AEs)
- An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An SAE is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
- Time frame - Up to Week 96
- Percentage of Participants with AEs of Special Interest (AESIs)
- AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.
- Time frame - Up to Week 96
- Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
- The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").
- Time frame - Up To Week 96
- Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
- The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").
- Time frame - Up To Week 96
- Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
- C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.
- Time frame - Up To Week 96
- Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)
- The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.
- Time frame - Up To Week 96
- Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)
- Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.
- Time frame - Up To Week 96
- Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.
- Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..
- Time frame - Up to Week 96
- Number of Participants with Abnormal Change From Baseline in Vital Sign
- Measurements like Systolic and Diastolic Blood Pressure will be Assessed Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
- Time frame - Up to Week 96
- Change From Baseline in Electrocardiograms (ECGs)
- 12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.
- Time frame - Up to Week 96
A Double-blind Study to Investigate Efficacy and Safety of Buntanetap Compared With Placebo in Participants With Early PD
- Sponsor: Annovis Bio Inc.
- The purpose of this study is to measure safety and efficacy of buntanetap/posiphen capsules compared with placebo capsules in participants with early PD.
- Study details include:
- The study duration will be up to 7-8 months.
- The double-blind treatment duration will be up to 6 months.
- There will be 5 in-clinic visits and 7 phone calls
- Interventions:
- Drug: buntanetap/posiphen
- Drug: Placebo
- Primary Outcome Measures:
- Change From Baseline to Month 6 in MDS-UPDRS Part II (OFF-state)
- Change in the Score from the MDS- Unified Parkinson's Disease Rating Scale (UPDRS) Parts II from Baseline to the End of Trial. MDS-UPDRS Part II (Motor experiences of daily living) has 13 items and the score ranges from 0-52, with higher scores reflecting greater severity.
- Time frame - Baseline and 6 months visits
To Evaluate the Efficacy of CVN424 in Parkinson's Disease Participants With Motor Complications
- Sponsor: Cerevance
- This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424, 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.
- Interventions:
- Drug: CVN424 75 mg
- Drug: CVN424 150 mg
- Drug: Placebo
- Primary Outcome Measures:
- Change from Baseline to Week 12 in average daily OFF time on motor diaries for 150 mg CVN424 compared to placebo
- The assessment of the average daily OFF time, normalized to waking hours will be based on diaries completed at home for three consecutive days during the 7-day period before a scheduled in-person visit.
- Time Frame - Baseline and Up to Week 12
Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1)
- Sponsor: Cerevel Therapeutics, LLC
- The purpose of this study is to evaluate the clinical efficacy, safety and pharmacokinetics (PK) of 2 fixed doses of tavapadon and placebo in participants with early PD.
- Interventions:
- Drug: Tavapadon
- Drug: Placebo
- Primary Outcome Measures:
- Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II and III Combined Score
- The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscales. Part II contains 13 sub-scores for the motor experiences of daily living and Part III, 33 sub-scores based on 18 items, several with right, left or other body distribution scores for the motor examination. Each sub-score is anchored with 5 responses that are linked to the commonly accepted clinical terms: 0=normal, 1=slight, 2=mild, 3=moderate, and 4=severe. The sub-score for each is summed to calculate the total scores. The scale range for Part II+III Total Score is 0-184 (Part II maximum total score 52 + Part III maximum total score132). The higher the score the greater the severity. A negative change from baseline represents an improvement in motor function.
- Time frame - 27 Weeks
A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's Disease (KW-6002)
- Sponsor: Kyowa Kirin Co., Ltd.
- This is a study to assess the efficacy and safety of oral Istradefylline (KW-6002) in patients with moderate to severe Parkinson's Disease. While on this study, participants will continue to take their usual, prescribed, stable regimen of Levodopa/Carbidopa or Levodopa/Benserazide therapy plus adjunct Parkinson's medications. Patients will be randomized 1:1:1 to receive either Istradefylline 20 mg per day, or Istradefylline 40 mg per day or an equivalent placebo. Patients will be treated for a 12 week period to demonstrate the effectiveness of Istradefylline in improving Parkinson's disease symptoms (referred to as improvement in patient OFF time) and that Istradefylline has an acceptable safety profile in this group.
- Interventions:
- Drug: Istradefylline 40 mg
- Drug: Istradefylline 20 mg
- Drug: Placebo
- Primary Outcome Measures:
- Change From Baseline in the Total Hours of Awake Time/Day Spent in the OFF State at Week 12
- Based on the 24-hour ON/OFF patient diary data.
- Time frame - Baseline, Week 2, Week 6, Week 10 and Week 12.
An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018
- Sponsor: Kyowa Kirin, Inc.
- This is a 1-year, open-label, long-term safety extension for patients who have completed prior istradefylline studies 6002-EU-007, 6002-US-013 or 6002-US-018.
- Interventions:
- Drug: Istradefylline ( KW-6002)
- Primary Outcome Measures:
- Safety
Potential Guidelines That May Be Affected Include:
- Parkinson’s Disease & Psychosis in the Post-Acute and Long-Term Care Setting
- Post-Acute and Long-Term Care Medical Association
- Publication: May 31, 2021
- Physical Therapist Management of Parkinson Disease
- American Physical Therapy Association
- Publication: December 27, 2021
And there you have it - a roundup of Phase 3 clinical trials for Parkinson's disease as of April 2025. Stay tuned for our next Guidelines+ Trials Rundown! In the meantime, explore more clinical trials and sign up for alerts to stay up to date with the latest published guidelines and research.
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