Trial · NCT07905976
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) and DLT | baseline up to 15 weeks | Safety and tolerability of single increasing IMM02-KORA doses |
| Secondary | Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | Determined by change from baseline of Abnormal Involuntary Movements Scale (AIMS). AIMS is 12-item scale scored by an observer to measure dyskinesia severity. Seven items are scored from 0-4 with zero being no dyskinesia observed and 4 being severe dyskinesia. Higher scores indicate a worse outcome. |
| Secondary | Obtain information on a minimum inhibitory dose (MID) on peak dose dyskinesia and evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | Determined by change from baseline of Hauser motor symptom diary |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on Cmax of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on Tmax of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on T1/2 of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by obtaining information on area under the plasma concentration versus time curve (AUC) of IMM02-KORA in serum. |
| Secondary | Obtain PK parameters necessary to calculate a repeated dose regimen | baseline up to 15 weeks | Determined by calculating a dose size and interval of administration that maintain a MID serum concentration |
| Secondary | Obtain information on treatment interference with neurotransmitters | baseline up to 15 weeks | Determined by change from pre-administration of serum dopamine, norepinephrine, epinephrine, and serotonin |
| Secondary | Obtain information on treatment interference with neurotransmitters | baseline up to 15 weeks | Determined by change from baseline of pre-administration of testosterone, FSH and LH levels |
| Secondary | Evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | Determined by post-treatment change from baseline of Abnormal Involuntary Movements Scale (AIMS) during the 1b portion. AIMS is 12-item scale scored by an observer to measure dyskinesia severity. Seven items are scored from 0-4 with zero being no dyskinesia observed and 4 being severe dyskinesia. Higher scores indicate a worse outcome. |
| Secondary | Evaluate initial efficacy of repeated administration on peak dose dyskinesia | baseline up to 15 weeks | Determined by post-treatment change from baseline of Hauser motor symptom diary during the 1b portion. |
| Secondary | Obtain additional efficacy information | baseline up to 15 weeks | Determined by change from baseline of Dyskinesia as measured by MDS-UPDRS (Unified Parkinson's Disease Rating Scale) Part IV. This scale has a minimum of 0 and a maximum of 24. Higher scores mean a worse outcome. |
| Secondary | Obtain additional efficacy information | baseline up to 15 weeks | Determined by change from baseline of grip strength measured with hand dynamometer |
| Secondary | Assess PK parameters during repeated dose administration | baseline up to 15 weeks | Determined by assessing bi-weekly the steady state serum concentration of IMM02-KORA during repeated administration during the 1b portion |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07905976/registered