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NCT02486432
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach
Phase 1 trial testing Levodopa/Carbidopa (Sinemet) in Parkinson's Disease in 6 participants. Completed in 1 April 2015.
1 April 2015
Quick facts
| Lead sponsor | NeuroDerm Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Enrollment | 6 |
| Start date | 1 April 2015 |
| Primary completion | 1 April 2015 |
| Estimated completion | 1 April 2015 |
Drugs / interventions tested
- Levodopa/Carbidopa (Sinemet) — full drug profile →
Conditions studied
- Parkinson's Disease — all drugs for Parkinson's Disease →
Sponsor
NeuroDerm Ltd. — full company profile →
Who can join
Adults 40 to 65, any sex, with Parkinson's Disease. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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The objective of the study is to provide safety and tolerability information for oral doses of levodopa and carbidopa administered as a divided dose.
Time frame: 5 weeks
Safety and tolerability will be assessed by: adverse events (AEs), physical examination, safety laboratory tests, vital signs and electrocardiograms (ECGs).
Sponsor's own description
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02486432
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Parkinson's Disease
Currently open trials in the same condition.
- NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
- NCT07330258 — A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite · recruiting
- NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
- NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
- NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting
Other NeuroDerm Ltd. trials
Trials by the same sponsor.
- NCT03462043 — A Study in Patients With Advanced Parkinson's Disease to Assess the Relative Bioavailability of Levodopa Administered as · Phase 3 · withdrawn
- NCT02577523 — A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's Disease · Phase 2 · completed
- NCT02604914 — A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects · Phase 1 · completed
- NCT02096601 — A Safety, Tolerability, and Pharmacokinetic Study of ND0612 Delivered as a Continuous Subcutaneous in Parkinson's Diseas · Phase 1 · completed
- NCT01883505 — A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkins · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02486432 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NeuroDerm Ltd.
- Last refreshed: 28 June 2015
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02486432.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing