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NCT00400634 · ClinicalTrials.gov registry record · Phase 2
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease
A Phase 2 study, sponsored by Sangamo Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 58
- Enrollment target
NCT00400634: Completed Phase 2 study, sponsored by Sangamo Therapeutics.
NCT00400634 is a Phase 2 study that has completed, run by Sangamo Therapeutics. The registered enrollment target is 58 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00400634, a Phase 2 study, has completed, sponsored by Sangamo Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 58 participants
- Enrollment target
Study Summary
The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).
Primary Outcome
The UPDRS (Unified Parkinson's Disease Rating Scale) is a clinical rating scale that assesses the symptomatic burden of Parkinson's Disease. The scale has four main sections, and each item is scored from a 0 to a 4 (higher number is more severe manifestation). Part III is a subsection devoted to motor function, has 14 questions, resulting in a score range of 0 (unaffected) to 56 (severely affected). The scale is administered by a trained clinician, and patients were assessed in a practically def
Interventions
- PROCEDURE Sham Surgery
- DRUG CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2006-11 |
| Est. Completion | 2008-11 |
| Phase | Phase 2 |
What the finished NCT00400634 record still lists
NCT00400634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Surgery is the first listed.
NCT00400634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00400634 about?
NCT00400634 is a clinical study titled "Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease". The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 \[AAV2\]-neurturin \[NTN\]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the ...
What is the current status of trial NCT00400634?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2006-11. Estimated completion is 2008-11.
What interventions are being tested in trial NCT00400634?
The interventions under investigation include: Sham Surgery (PROCEDURE), CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) (DRUG).
Who is sponsoring clinical trial NCT00400634?
This trial is sponsored by Sangamo Therapeutics, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00400634's enrollment target sits among peer trials
58 1135th of 2000 higher than 860 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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