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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3814-021 | Other Identifier | Merck |
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The purpose of this study is to assess the long term safety of SCH 420814 (preladenant) in participants with moderate to severe Parkinson's Disease who are taking an L-Dopa/dopa decarboxylase inhibitor and/or dopamine agonist. All participants must have participated in the main study (P04501; NCT00406029) entitled "A Phase 2, 12 Week, Double Blind, Dose Finding, Placebo Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesias."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preladenant 5 mg BID | Experimental | Preladenant 5 mg twice daily (BID) given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preladenant | Drug | 5 mg BID capsules |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect. | Up to 42 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in "Off" State Per Day | Participant diaires recorded time spent in the "off" state at half-hourly intervals for at least 3 full days before scheduled visits. "Off" time is defined as when the participant's medication is not working as subjectively determined by the participant and his/her physician. Higher "off" time values relative to Baseline (BL) signify that the Parkinson's disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23589371 | Result | Factor SA, Wolski K, Togasaki DM, Huyck S, Cantillon M, Ho TW, Hauser RA, Pourcher E. Long-term safety and efficacy of preladenant in subjects with fluctuating Parkinson's disease. Mov Disord. 2013 Jun;28(6):817-20. doi: 10.1002/mds.25395. Epub 2013 Apr 15. |
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Screening for entry into the TP was performed over an 8 day period.
Participants from Study P04501 (NCT00406029) were enrolled into this study (Treatment Phase [TP] and Follow-up Phase [FUP]).
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| ID | Title | Description |
|---|---|---|
| FG000 | Preladenant 5 mg BID | Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
|
| ||||||||||||||||||||||||
| Follow-up Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preladenant 5 mg BID | Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Time Spent in "Off" State Per Day | Participant diaires recorded time spent in the "off" state at half-hourly intervals for at least 3 full days before scheduled visits. "Off" time is defined as when the participant's medication is not working as subjectively determined by the participant and his/her physician. Higher "off" time values relative to Baseline (BL) signify that the Parkinson's disease symptoms are worse (i.e., participant can only move slowly or not at all). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | Hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
Up to 42 weeks
All participants who received treatment with study drug were included in the analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Preladenant 5 mg BID | Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019636 | Neurodegenerative Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
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| ID | Term |
|---|---|
| C539997 | 2-(2-furanyl)-7-(2-(4-(4-(2-methoxyethoxy)phenyl)-1-piperazinyl)ethyl)-7H-pyrazolo(4,3-e)(1,2,4)triazolo(1,5-c)pyrimidine-5-amine |
| D007980 | Levodopa |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| L-dopa | Drug | Participants must receive L-dopa as part of their usual ongoing treatment for Parkinson's Disease. L-dopa is often administered concomitantly with a dopa decarboxylase inhibitor (e.g., carbidopa). |
|
| Other Parkinson's Disease treatments | Drug | Participants may also receive other drugs as part of their usual ongoing treatment for Parkinson's Disease, such as dopamine agonists (e.g., pramipexole) and/or the catechol-O methyl transferase (COMT) inhibitor entacapone. |
|
| Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Awake Time Per Day in the "on" State | Participant diaries recorded time spent in the "on" state at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Higher "on" time values relative to BL mean that the Parkinson's disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Time Spent in the "on" State With no Dyskinesias | Participant diaries recorded time spent in the "on" state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time. Higher values relative to BL signify an improvement in the Parkinson's disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Time Spent in the "on" State With Troublesome Dyskinesias | Participant diaries recorded time spent in the "on" state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Time Spent in the "on" State Without Troublesome Dyskinesia | Participant diaries recorded time spent in the "on" state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Absolute Duration of Dyskinesias | Participant diaries recorded time spent in the "on" state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
| Total Sleep Time | Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Preladenant 5 mg BID |
Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen. |
|
|
| Secondary | Awake Time Per Day in the "on" State | Participant diaries recorded time spent in the "on" state at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Higher "on" time values relative to BL mean that the Parkinson's disease symptoms are better or absent (i.e., participant can move well). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Secondary | Time Spent in the "on" State With no Dyskinesias | Participant diaries recorded time spent in the "on" state with no dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time. Higher values relative to BL signify an improvement in the Parkinson's disease symptoms (i.e., participant can move well) concomitant with no dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Secondary | Time Spent in the "on" State With Troublesome Dyskinesias | Participant diaries recorded time spent in the "on" state with troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Secondary | Time Spent in the "on" State Without Troublesome Dyskinesia | Participant diaries recorded time spent in the "on" state without troublesome dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time; troublesome dyskinesias interfere with function or cause discomfort. Higher values relative to BL signify that the Parkinson's disease symptoms are better or absent (i.e., participant can move well) concomitant with absence of troublesome dyskinesias. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Secondary | Absolute Duration of Dyskinesias | Participant diaries recorded time spent in the "on" state with dyskinesias at half-hourly intervals for at least 3 full days before scheduled visits. "On" time is defined as when the participant's medication is working as subjectively determined by the participant and his/her physician. Dyskinesias are a side effect of long-term therapy with L-dopa consisting of unintentional twisting and/or turning movements that occur in the "on" time. Higher values relative to BL signify worsening of dyskinesia (i.e., more time spent with dyskinesia). BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Secondary | Total Sleep Time | Participant diaries recorded time spent in the sleep state at half-hourly intervals for at least 3 full days before scheduled visits. BL was determined using two methods: 1) P04501 BL refers to the starting BL of the double-blind base study P04501 and 2) P04501 BL_LA refers to BL as defined by the last assessment taken in P04501. Endpoint refers to the last observed result for participants within P05175. | All participants with a baseline value and at least one post-baseline value were included in the analysis. | Posted | Mean | Standard Deviation | hours/day | Baseline (P04501 BL; P04501 BL_LA), Week 4, Week 8, Week 12, Week 24, Week 36 |
|
|
|
| Primary | Number of Participants Who Experienced at Least One Adverse Event | An adverse event is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure. A serious adverse event is an adverse event that that results in death, life threatening adverse event, permanent or significant disability / unfitness for work, hospital treatment (i.e., admission to hospital) or prolongation of a patient's length of stay, or congenital deformity or birth defect. | All participants who received treatment with study drug were included in the analysis. | Posted | Number | Participants | Up to 42 weeks |
|
|
|
| 22 |
| 140 |
| 96 |
| 140 |
| Amaurosis Fugax | Eye disorders | MedDRA 12.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Abasia | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
|
| Akinesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Completed Suicide | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hallucination, Visual | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Hallucinations, Mixed | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
| Cystocele | Reproductive system and breast disorders | MedDRA 12.1 | Systematic Assessment |
|
| Benign Tumour Excision | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Inguinal Hernia Repair | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Shoulder Arthroplasty | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Orthostatic Hypotension | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
|
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 12.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Parkinson's Disease | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
|
The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the study.
| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|
| Title | Measurements |
|---|---|
|
| Week 8 (n=119) |
|
| Week 12 (n=119) |
|
| Week 24 (n=110) |
|
| Week 36 (n=99) |
|
| Endpoint (n=133) |
|