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NCT00650104 · ClinicalTrials.gov registry record · Phase 3

Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
76
Enrollment target

NCT00650104: Completed Phase 3 study, sponsored by GlaxoSmithKline.

NCT00650104 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 76 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00650104, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
76 participants
Enrollment target

Study Summary

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

Primary Outcome

The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairmen

Interventions

  • DRUG Ropinirole XL (formerly CR)

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2002-05
Est. Completion 2009-03
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT00650104 record still lists

NCT00650104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Ropinirole XL (formerly CR) is the first listed.

NCT00650104 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00650104 about?

NCT00650104 is a clinical study titled "Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164". The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.

What is the current status of trial NCT00650104?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 76 participants. The study started on 2002-05. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00650104?

The interventions under investigation include: Ropinirole XL (formerly CR) (DRUG).

Who is sponsoring clinical trial NCT00650104?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00650104's enrollment target sits among peer trials

76 1773rd of 2000 higher than 228 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00650104, the US trial registry maintained by the National Library of Medicine. NCT00650104 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.