A Phase 3 interventional study of Preladenant 2 mg tablet and Preladenant 5 mg tablet in Parkinson Disease, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-11-07.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment
This is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).
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Preladenant 2 mg oral tablet and placebo for rasagiline taken in the morning (AM) followed by preladenant 2 mg oral tablet taken in the evening (PM) for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Drug: Preladenant 2 mg tablet · Drug: Placebo for Rasagiline 1 mg capsule
Preladenant 5 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 5 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Drug: Preladenant 5 mg tablet · Drug: Placebo for Rasagiline 1 mg capsule
Preladenant 10 mg oral tablet and placebo for rasagiline taken in the AM followed by preladenant 10 mg taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Drug: Preladenant 10 mg tablet · Drug: Placebo for Rasagiline 1 mg capsule
Placebo for preladenant and placebo for rasagiline taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
Drug: Preladenant 5 mg tablet · Drug: Placebo for Rasagiline 1 mg capsule · Drug: Placebo for Preladenant
Rasagiline 1 mg oral capsule and placebo for preladenant taken in the AM followed by placebo for preladenant taken in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
Drug: Rasagiline 1 mg capsule · Drug: Placebo for Preladenant
Preladenant 2 mg oral tablet taken twice daily
Also known as: SCH 420814
Preladenant 5 mg oral tablet taken twice daily
Also known as: SCH 420814
Preladenant 10 mg oral tablet taken twice daily
Also known as: SCH 420814
Rasagiline 1 mg oral capsule taken once daily
Also known as: Azilect
Placebo for rasagiline 1 mg oral capsule taken once daily
Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily
Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3)
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
Time frame: Baseline and Week 26
Number of Participants With Adverse Events (AEs) in Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time frame: Day 1 to Week 26
Number of Participants Who Discontinued Study Due to an AE in Part 1
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time frame: Day 1 to Week 26
Number of Participants With Adverse Events (AEs) in Part 2
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time frame: Week 27 to Week 52
Number of Participants Who Discontinued Study Due to an AE in Part 2
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
Time frame: Week 27 to Week 52
Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3)
UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.
Time frame: Baseline and Week 26
Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL])
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
Time frame: Baseline and Week 26
Participants with a diagnosis of idiopathic PD for less than 5 years were selected to participate in this study.
| Milestone | Preladenant 2 mg | Preladenant 5 mg | Preladenant 10 mg | Placebo | Rasagiline |
|---|---|---|---|---|---|
| Started | 204 | 204 | 206 | 204 | 204 |
| Treated | 200 | 202 | 204 | 198 | 203 |
| Completed | 166 | 177 | 167 | 177 | 181 |
| Not completed | 38 | 27 | 39 | 27 | 23 |
| Withdrew: Adverse event | 13 | 8 | 18 | 7 | 6 |
| Withdrew: Administrative | 2 | 2 | 2 | 0 | 0 |
| Withdrew: Did not meet protocol eligibility | 3 | 1 | 2 | 1 | 3 |
| Withdrew: Withdrawal by subject | 11 | 13 | 8 | 8 | 9 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Treatment failure | 3 | 0 | 3 | 1 | 2 |
| Withdrew: Did not receive treatment | 4 | 2 | 2 | 6 | 1 |
| Withdrew: Non-compliance with protocol | 2 | 1 | 3 | 3 | 2 |
| Milestone | Preladenant 2 mg | Preladenant 5 mg | Preladenant 10 mg | Placebo | Rasagiline |
|---|---|---|---|---|---|
| Started | 166 | 177 | 167 | 177 | 181 |
| Completed | 107 | 116 | 109 | 127 | 126 |
| Not completed | 59 | 61 | 58 | 50 | 55 |
| Withdrew: Adverse event | 7 | 6 | 8 | 3 | 4 |
| Withdrew: Administrative | 43 | 49 | 36 | 38 | 46 |
| Withdrew: Withdrawal by subject | 8 | 4 | 12 | 7 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 1 |
| Withdrew: Treatment failure | 0 | 1 | 2 | 0 | 1 |
| Withdrew: Non-compliance with protocol | 0 | 1 | 0 | 2 | 0 |
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician. The UPDRS Part 3 is the Motor Examination (Total Motor Score \[TMS\]) and is defined as the total score, ranging from 0-108 as determined by the physician, of the tests given in the motor examination section. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. Change from baseline was analyzed using a constrained longitudinal analysis (cLDA) model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
| Score on a Scale | Preladenant 2 mg (Part 1) | Preladenant 5 mg (Part 1) | Preladenant 10 mg (Part 1) | Placebo (Part 1) | Rasagiline (Part 1) |
|---|---|---|---|---|---|
| Change From Baseline in the Sum of Unified Parkinson's Disease Rating Scale Parts 2 and 3 Scores (UPDRS2+3) | 0.3 ± 0.63 | -1.0 ± 0.60 | -1.8 ± 0.61 | -2.2 ± 0.61 | -1.9 ± 0.61 |
UPDRS is a clinician based rating scale used to measure motor impairments and disability; it assesses 6 features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. UPDRS Part 2 is Activities of Daily Living score and ranges from 0-52. UPDRS Part 3 is Motor Examination and ranges from 0-108. The combined scores of Parts 2 and 3 can range from 0-160 with the higher score indicating the worse condition. A Responder is defined as a participant with at least 20% improvement in UPDRS2+3 from Baseline to Week 26 (End of Part 1 Treatment); a participant with at least a 20% decrease from Baseline score in UPDRS2+3 is defined as a responder. The proportion of Responders was analyzed using a generalized linear mixed model with treatment effect, strata and Baseline UPDRS2+3 as a covariate, and treatment-by-time interaction as fixed effects and subject as random effect.
| Percentage of Responders | Preladenant 2 mg (Part 1) | Preladenant 5 mg (Part 1) | Preladenant 10 mg (Part 1) | Placebo (Part 1) | Rasagiline (Part 1) |
|---|---|---|---|---|---|
| Percentage of Responders (Participants With a ≥20% Improvement in UPDRS2+3) | 25.90 (18.95 to 34.33) | 29.50 (22.50 to 37.72) | 31.50 (24.06 to 40.02) | 35.20 (27.49 to 43.82) | 33.10 (25.60 to 41.51) |
The UPDRS is a clinician based rating scale used to measure motor impairments and disability. The UPDRS assesses six features of PD impairment. These are evaluated using a combination of data collected by interview and examination of the participant. The UPDRS Part 2 is the Activities of Daily Living (ADL) score and can range from 0-52 as determined by the physician with the higher score indicating the worse condition. Change from baseline was analyzed using a cLDA model with treatment, time, strata and treatment-by-time interaction as fixed effects and participant as a random effect.
| Score on a Scale | Preladenant 2 mg (Part 1) | Preladenant 5 mg (Part 1) | Preladenant 10 mg (Part 1) | Placebo (Part 1) | Rasagiline (Part 1) |
|---|---|---|---|---|---|
| Change From Baseline in the UPDRS Part 2 Score (Activities of Daily Living [ADL]) | 0.30 ± 0.22 | 0.10 ± 0.21 | -0.20 ± 0.21 | -0.40 ± 0.21 | -0.20 ± 0.21 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
| Participants | Preladenant 2 mg (Part 1) | Preladenant 5 mg (Part 1) | Preladenant 10 mg (Part 1) | Placebo (Part 1) | Rasagiline (Part 1) |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) in Part 1 | 108 | 110 | 121 | 102 | 105 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
| Participants | Preladenant 2 mg (Part 1) | Preladenant 5 mg (Part 1) | Preladenant 10 mg (Part 1) | Placebo (Part 1) | Rasagiline (Part 1) |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Due to an AE in Part 1 | 13 | 8 | 20 | 8 | 6 |
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
| Participants | Preladenant 2 mg (Part 2) | Preladenant 5 mg (Part 2) | Preladenant 10 mg (Part 2) | Placebo (Part 2) | Rasagiline (Part 2) |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs) in Part 2 | 116 | 120 | 113 | 120 | 119 |
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.
| Participants | Preladenant 2 mg (Part 2) | Preladenant 5 mg (Part 2) | Preladenant 10 mg (Part 2) | Placebo (Part 2) | Rasagiline (Part 2) |
|---|---|---|---|---|---|
| Number of Participants Who Discontinued Study Due to an AE in Part 2 | 7 | 5 | 8 | 3 | 4 |
Collected over Up to 54 weeks (including 2 weeks of follow-up). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Preladenant 2 mg - Part 1 | — | 4/200 (2%) | 33/200 (16.5%) |
| Preladenant 5 mg - Part 1 | — | 5/202 (2.5%) | 39/202 (19.3%) |
| Preladenant 10 mg - Part 1 | — | 8/204 (3.9%) | 40/204 (19.6%) |
| Placebo - Part 1 | — | 3/198 (1.5%) | 36/198 (18.2%) |
| Rasagiline - Part 1 | — | 9/203 (4.4%) | 34/203 (16.7%) |
| Preladenant 2 mg - Part 2 | — | 7/166 (4.2%) | 18/166 (10.8%) |
| Preladenant 5 mg - Part 2 | — | 1/177 (0.6%) | 22/177 (12.4%) |
| Preladenant 10 mg - Part 2 | — | 8/167 (4.8%) | 17/167 (10.2%) |
| Placebo/Preladenant 5 Mg-Part 2 | — | 4/177 (2.3%) | 16/177 (9%) |
| Rasagiline - Part 2 | — | 8/181 (4.4%) | 19/181 (10.5%) |
| Event | Preladenant 2 mg - Part 1 | Preladenant 5 mg - Part 1 | Preladenant 10 mg - Part 1 | Placebo - Part 1 | Rasagiline - Part 1 | Preladenant 2 mg - Part 2 | Preladenant 5 mg - Part 2 | Preladenant 10 mg - Part 2 | Placebo/Preladenant 5 Mg-Part 2 | Rasagiline - Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|
| Atrial FibrillationCardiac disorders | 0/200 | 0/202 | 1/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| AppendicitisInfections and infestations | 0/200 | 0/202 | 1/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| PneumoniaInfections and infestations | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Femur FractureInjury, poisoning and procedural complications | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Suicide AttemptPsychiatric disorders | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Cystitis HaemorrhagicRenal and urinary disorders | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 1/181 |
| PhlebitisVascular disorders | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 1/166 | 0/177 | 0/167 | 0/177 | 0/181 |
| Acute Myocardial InfarctionCardiac disorders | 0/200 | 0/202 | 0/204 | 0/198 | 0/203 | 0/166 | 0/177 | 1/167 | 0/177 | 0/181 |
| Event | Preladenant 2 mg - Part 1 | Preladenant 5 mg - Part 1 | Preladenant 10 mg - Part 1 | Placebo - Part 1 | Rasagiline - Part 1 | Preladenant 2 mg - Part 2 | Preladenant 5 mg - Part 2 | Preladenant 10 mg - Part 2 | Placebo/Preladenant 5 Mg-Part 2 | Rasagiline - Part 2 |
|---|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 13/200 | 10/202 | 15/204 | 5/198 | 10/203 | 11/166 | 4/177 | 9/167 | 5/177 | 7/181 |
| TremorNervous system disorders | 8/200 | 7/202 | 3/204 | 11/198 | 6/203 | 7/166 | 11/177 | 5/167 | 8/177 | 6/181 |
| HypertensionVascular disorders | 4/200 | 11/202 | 11/204 | 11/198 | 11/203 | 1/166 | 5/177 | 6/167 | 4/177 | 5/181 |
| DizzinessNervous system disorders | 7/200 | 11/202 | 5/204 | 9/198 | 10/203 | 4/166 | 1/177 | 4/167 | 1/177 | 6/181 |
| ConstipationGastrointestinal disorders | 5/200 | 9/202 | 11/204 | 5/198 | 3/203 | 1/166 | 1/177 | 4/167 | 4/177 | 2/181 |
| Back PainMusculoskeletal and connective tissue disorders | 6/200 | 10/202 | 8/204 | 6/198 | 6/203 | 3/166 | 9/177 | 3/167 | 7/177 | 7/181 |
All Participants as Randomized
| Age, Continuous(Years) | Preladenant 2 mg | Preladenant 5 mg | Preladenant 10 mg | Placebo | Rasagiline | Total |
|---|---|---|---|---|---|---|
| Mean | 63.0 ± 10.5 | 62.3 ± 10.2 | 63.8 ± 11.1 | 63.3 ± 10.0 | 62.9 ± 10.2 | 63.1 ± 10.4 |
| Sex: Female, Male(Participants) | Preladenant 2 mg | Preladenant 5 mg | Preladenant 10 mg | Placebo | Rasagiline | Total |
|---|---|---|---|---|---|---|
| Female | 78 | 90 | 90 | 82 | 85 | 425 |
| Male | 126 | 114 | 116 | 122 | 119 | 597 |
No study locations are listed for this record.
Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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