Trial · NCT01190735
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tolerability | 6 weeks | Patients will be given a structured questionnaire targeting common side effects of caffeine, as well as a series of open-ended questions for other side effects. Vital signs will be measured. Questionnaire symptoms will be selected, where available, from the common terminology criteria for adverse events, version 3.0, developed by the National Cancer Institute. A severity of 2 or greater on the 5-point scale will delineate a dose-limiting effect. Evaluations will occur in person after 2 weeks, 4 weeks, 6 weeks (at study termination) and via telephone follow-up at the end of weeks 1,3 and 5. |
| Secondary | Epworth Sleepiness Scale (ESS) | 6 weeks | Will systematically track changes in ESS. |
| Secondary | Unified Parkinson Disease Rating Scale(UPDRS): Part II | 6 weeks | Systematically performing part II of the UPDRS, motor examination. |
| Secondary | Timed Up and Go (TUG) | 6 weeks | This is a measure of gait and transfer speed. |
| Secondary | Clinical Global Impression of Change | 6 weeks | |
| Secondary | Pittsburgh Sleep Quality Index | 6 weeks | |
| Secondary | Fatigue Severity Scale | 6 weeks | |
| Secondary | The Parkinson's Disease Questionnaire - PDQ-39 | 6 weeks | This self-completion questionnaire addresses aspects of functioning and well-being in those affected by Parkinson's Disease (PD). Considered to be the industry 'gold standard' in the assessment of quality of life in PD patients. The 39-point PDQ provides scores on 8 scales: mobility, activities of daily living, emotions, stigma, social support, cognition, communications and bodily discomfort. |
| Secondary | Beck Depression Inventory | 6 weeks | Self-administered questionnaire. |
| Secondary | Beck Anxiety Inventory | 6 weeks | Self-administered questionnaire. |
| Secondary | UPDRS: Part I,II,IV | 6 weeks | Systematically querying I (non-motor aspects of activities of daily living), II (motor aspects of activities of daily living) and IV (motor complications) |
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/NCT01190735/registered