Trial · NCT01631825
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Adverse Events (AEs), Vital Signs, and Laboratory Parameters | Up to 55 weeks after dosing | The safety of the long-term SPM 962 treatment was examined based on the incidence and severity of AEs, vital signs, and laboratory parameters. AEs of special interest (1-3) are defined as below: 1. sudden onset of sleep 2. obsessive-compulsive disorder or impulse-control disorder 3. hallucination, delusion Application site reaction is scored as -, ±, +, ++, +++, or ++++. More + indicates a greater severity of symptoms. The worst score obtained throughout the evaluation period was to be assessed. |
| Secondary | Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 Sum Score | Baseline, Up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 3 sum score (on state). UPDRS is a scale for monitoring Parkinson's Disease-related disability and impairment. The UPDRS consists of the following four sub-scales. Part 1: Mentation, Part 2: Activities of Daily Living, Part 3: Motor, Part 4: Complications. Part 3 assesses 14 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
| Secondary | UPDRS Part 2 Sum Score (Average of on State and Off State) | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (average of on state and off state). UPDRS sub-scale Part 2 assesses 13 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
| Secondary | Absolute Time Spent "Off" | Baseline, up to 54 weeks after dosing | Mean number of hours in "off state" during a 24-hour period. |
| Secondary | UPDRS Part 1 Sum Score | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 1 sum score. UPDRS sub-scale Part 1 assesses 4 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
| Secondary | UPDRS Part 2 Sum Score (On State) | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (on state). A decrease in the scores means improvement. |
| Secondary | UPDRS Part 2 Sum Score (Off State) | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 2 sum score (off state). A decrease in the scores means improvement. |
| Secondary | UPDRS Part 4 Sum Score | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in UPDRS Part 4 sum score. UPDRS sub-scale Part 4 assesses 11 items. Each item is scored from 0 (normal) to 4 (severe). The sum score serves as the sub-scale score. A higher score indicates a greater severity of symptoms. Thus a decrease in the scores means improvement. |
| Secondary | Total of UPDRS Part 1 Sum Score, UPDRS Part 2 Sum Score (Average of on State and Off State), UPDRS Part 3 Sum Score (on State), and UPDRS Part 4 Sum Score | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in total of UPDRS Part 1 sum score, UPDRS Part 2 sum score (average of on state and off state), UPDRS Part 3 sum score (on state), and UPDRS Part 4 sum score. A decrease in the scores means improvement. |
| Secondary | The Modified Hoehn & Yahr Severity of Illness | Baseline, up to 54 weeks after dosing. | Change (LOCF) from baseline in the Modified Hoehn \& Yahr Severity of Illness. The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for staging: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease without impairment of balance; 2.5, Mild bilateral disease with recovery on pull test; 3, Mild to moderate bilateral disease, some postural instability, physically independent 4, Severe disability, still able to walk or stand unassisted; and 5, Wheelchair bound or bedridden unless aided. The data at week 52 is shown. |
| Secondary | Each Item of UPDRS Part 1 | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 1. The data at week 52 is shown. |
| Secondary | Each Item of UPDRS Part 2 (on State) | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 2 (on state). The data at week 52 is shown. |
| Secondary | Each Item of UPDRS Part 2 (Off State) | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 2 (off state). The data at week 52 is shown. |
| Secondary | Each Item of UPDRS Part 2 (Average of on State and Off State) | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 2 (average of on state and off state). The data at week 52 is shown. |
| Secondary | Total of UPDRS Part 2 Sum Score (Average of on State and Off State) and UPDRS Part 3 Sum Score (on State) | Baseline, up to 54 weeks after dosing | Mean change (LOCF) from baseline in total of UPDRS Part 2 sum score (average of on state and off state) and UPDRS Part 3 sum score (on state). A decrease in the scores means improvement. |
| Secondary | Each Item of UPDRS Part 3 (on State) | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 3 (on state). The data at week 52 is shown. |
| Secondary | Each Item of UPDRS Part 4 | Baseline, up to 54 weeks after dosing. | The percentage of subjects with elevated scores for each item of UPDRS Part 4. The data at week 52 is shown. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT01631825/registered