Moderate to Severe Idiopathic RLS With Daytime Symptoms Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).
| Verified date | October 2018 |
| Source | Mundipharma Research GmbH & Co KG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The primary objective for the 12-week Titration-/Maintenance Period is:
To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom
severity of RLS.
| Status | Completed |
| Enrollment | 205 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Moderate to severe idiopathic RLS with daytime symptoms Exclusion Criteria: - Females who are pregnant or lactating. - Subjects with evidence of significant structural abnormalities of the gastrointestinal tract. - Subjects with evidence of impaired liver/kidney function upon entry into the study |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Paracelsus Elena Klinik | Kassel |
| Lead Sponsor | Collaborator |
|---|---|
| Mundipharma Research GmbH & Co KG |
Germany, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in the IRLS score between the two treatment arms will be compared | The primary objective for the 12-week Titration-/Maintenance Period is: IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period. |
12 weeks and a 6 month extension |